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Oct 09
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U.S. Food and Drug Administration (FDA) accepts New Drug Application for elinzanetant

By Advent Life Sciences, KaNDy Therapeutics, Press Release
Press Release.

 

U.S. Food and Drug Administration (FDA) accepts New Drug Application for elinzanetant

  • The New Drug Application (NDA) for elinzanetant, an investigational compound for the treatment of moderate to severe vasomotor symptoms associated with menopause, is based on the positive data from three Phase III studies OASIS 1, 2 and 3
  • Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily
BERLIN–(BUSINESS WIRE)–Bayer today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for the investigational compound elinzanetant seeking approval for the treatment of moderate-to-severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause.

“If approved, elinzanetant will offer a new non-hormonal option to women seeking treatment for moderate to severe vasomotor symptoms and we look forward to the review by the agency.”

Post this

“The NDA acceptance of elinzanetant by the FDA marks a significant milestone in our efforts to advance menopause care for women in the U.S.,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, Member of the Pharmaceutical Leadership Team at Bayer.“If approved, elinzanetant will offer a new non-hormonal option to women seeking treatment for moderate to severe vasomotor symptoms and we look forward to the review by the agency.”

The NDA application is based on the positive results from the OASIS 1, 2 and 3 Phase III studies evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo. Findings from OASIS 1 and 2 were published in August 2024 in JAMA.1 Detailed results of the Phase III study OASIS 3 providing supporting efficacy and additional long-term safety data were presented at The Menopause Society (TMS) annual meeting in September 2024.

Bayer is continuing to submit applications for marketing authorizations of elinzanetant to further health authorities as well.

About the Elinzanetant clinical development program
The Phase III clinical development program of elinzanetant, OASIS, currently comprises four Phase III studies: OASIS 1, 2, 3 and 4. OASIS 1 and 2 investigated the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause over 26 weeks and randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries. Patients in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks and patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks. OASIS 3 investigated the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms over 52 weeks in postmenopausal women and randomized 628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries. The OASIS 4 study is an expansion of the clinical Phase III program and investigates the efficacy and safety of elinzanetant in women with moderate to severe VMS caused by endocrine therapy for treatment or prevention of breast cancer.

In addition to the OASIS program, Bayer is conducting NIRVANA (NCT06112756), an exploratory Phase II randomized, parallel-group treatment, double-blind study. The primary objective is to explore the efficacy of elinzanetant on sleep disturbances associated with menopause (SDM) as determined by polysomnography (PSG). PSG is a validated method to study sleep and underlying causes of sleep disturbances. Additional objectives include exploring the efficacy of elinzanetant on SDM as determined by patient-reported outcomes and further evaluating the safety of elinzanetant.

About Elinzanetant
Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily. Elinzanetant may address moderate to severe VMS by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS. Based on key secondary endpoints of OASIS 1 and 2, Elinzanetant may also decrease sleep disturbances associated with menopause.

About Vasomotor Symptoms
Vasomotor symptoms (VMS; also referred to as hot flashes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons. This is due to a decrease of estrogen, which can result from the progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or endocrine therapy.

VMS are reported by up to 80% of women at some point during the menopausal transition and are one of the leading causes for seeking medical attention during this phase of a woman’s life. Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact on quality of life.

VMS may also be caused by endocrine therapy, for the treatment or prevention of breast cancer, impacting quality of life and treatment adherence. For these women, there are currently no approved treatment options.

About Menopause
By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million women entering this phase each year. Menopause is a transitional phase in women’s lives, related to the progressive decline of ovarian function. It usually occurs in women during their 40s or early 50s. It can also be the result of surgical or medical treatment such as breast cancer treatment. The hormonal decline can lead to various symptoms which can substantially affect a woman’s health, quality of life, healthcare utilization and work productivity. The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes. Addressing these symptoms is key to maintaining functional ability and quality of life in menopause which is highly relevant from both a healthcare and socio-economic perspective.

About Women’s Healthcare at Bayer
Women’s Health is in Bayer’s DNA. As a global leader in women’s healthcare Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer
Follow us on LinkedIn: Bayer | Pharmaceuticals

kw (2024-0157E)

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conformthem to future events or developments.

_________________________
1 https://jamanetwork.com/journals/jama/fullarticle/2822766

Contacts

Contact for US media inquiries:
Courtney Ambrosi, phone 1 (908) 798-1107
Email: courtney.ambrosi@bayer.com

Contact for global media inquiries:
Katja Wiggers, phone +49 30 221541614
Email: katja.wiggers@bayer.com

Jan 09
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Bayer’s elinzanetant meets all primary and key secondary endpoints in pivotal OASIS 1 and 2 Phase III studies

By KaNDy Therapeutics, Press Release, Private Companies
Press Release.

 

Bayer’s elinzanetant meets all primary and key secondary endpoints in pivotal OASIS 1 and 2 Phase III studies

 

OASIS 1 and 2 pivotal studies evaluating investigational compound elinzanetant met all primary endpoints demonstrating a statistically significant reduction in frequency and severity of moderate to severe vasomotor symptoms (VMS) compared to placebo in postmenopausal women / Both studies also showed superiority over placebo for all key secondary endpoints with a statistically significant reduction in frequency of VMS at week 1, as well as improvement of sleep disturbances and menopause-related quality of life / The safety profile observed in both studies is overall consistent with previously published data on elinzanetant / OASIS 1 and 2 are two of three Phase III clinical studies investigating the efficacy and safety of elinzanetant, a first dual neurokinin-1,3 (NK-1,3) receptor antagonist, as a non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily

Berlin, January 8, 2024 – Bayer today announced positive top-line results of the pivotal Phase III studies OASIS 1 and 2 evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo. Elinzanetant successfully met all four primary endpoints in both studies demonstrating statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to week 4 and 12 compared to placebo.

Both studies also achieved all three key secondary endpoints showing a statistically significant reduction in the frequency of VMS from baseline to week 1, as well as statistically significant improvements in sleep disturbances and menopause-related quality of life compared to placebo. The safety profile observed in the OASIS 1 and 2 studies is overall consistent with previously published data1,2 on elinzanetant.

“We are excited about the positive results of these two pivotal Phase III studies for elinzanetant, reinforcing its potential as a non-hormonal treatment option in menopause management,” said Dr. Christian Rommel, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development. “We want to thank the women participating in the OASIS studies, their families, and all study investigators as well as their clinical and nursing staff for their time and commitment to advance menopause research.”

Elinzanetant is a first dual neurokinin-1,3 (NK-1,3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily.

“Menopausal symptoms such as hot flashes and sleep disturbances can be highly disruptive and broadly impact health and quality of life, still many women cope in silence and remain untreated,” said JoAnn Pinkerton, M.D., Professor and Director of Midlife Health at UVA Health. “It’s important that we continue to research for solutions that address the unmet needs of women, and I am looking forward to the unveiling of the full results.”

OASIS 1 and 2 (NCT05042362 and NCT05099159) are the first two Phase III studies in the OASIS clinical development program with results, and the details are planned to be presented at upcoming scientific congresses. The results of the third Phase III study OASIS 3 (NCT05030584) are expected in the coming months. Bayer plans to submit data from the OASIS 1, 2 and 3 studies to health authorities for approval of marketing authorizations for treatment of moderate to severe VMS associated with menopause.

About the OASIS 1 and 2 studies
OASIS 1 and 2 are double-blind, randomized, placebo-controlled multicenter studies investigating the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause. OASIS 1 and 2 randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries.

About the OASIS Clinical Development Program
The Phase III clinical development program of elinzanetant, OASIS, currently comprises four Phase III studies: OASIS 1, 2, 3 and 4. The OASIS 1, 2 and 3 studies investigate the efficacy and safety of elinzanetant 120 mg in women with moderate to severe VMS associated with menopause. The OASIS 4 study is an expansion of the clinical phase III program and investigates the efficacy and safety of elinzanetant in women with moderate to severe VMS caused by endocrine therapy for treatment or prevention of breast cancer.

The design and dosing of the Phase III clinical development program is based on the positive data from two Phase II studies (RELENT-1 and SWITCH-1). RELENT-1 was a Phase Ib/IIa study investigating the safety, pharmacokinetics and preliminary efficacy of elinzanetant. SWITCH-1 was a Phase IIb study investigating the efficacy and safety of four different doses of elinzanetant compared to placebo in women with VMS.

About Elinzanetant
Elinzanetant is a first dual neurokinin-1,3 (NK-1,3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily. Elinzanetant may address moderate to severe VMS by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS. Elinzanetant may also decrease sleep disturbances associated with menopause.

About Vasomotor Symptoms
Vasomotor symptoms (VMS; also referred to as hot flashes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons. This is due to a decrease of estrogen, which can result from the progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or endocrine therapy.

VMS are reported by up to 80% of women at some point during the menopausal transition and are one of the leading causes for seeking medical attention during this phase of a woman’s life. Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact on quality of life.

VMS may also be caused by endocrine therapy, for the treatment or prevention of breast cancer, impacting quality of life and treatment adherence. For these women, there are currently no approved treatment options.

About Menopause
By 2030, the world population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million new women entering this phase each year. Menopause is a transitional phase in women’s lives, related to the progressive decline of ovarian function, and which usually occurs in women during their 40s or early 50s. It can also be the result of surgical or medical treatment, for example breast cancer treatment. The hormonal decline can lead to various symptoms which can substantially affect a woman’s health, quality of life, healthcare utilization and work productivity. The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes. Addressing these symptoms is key to maintaining functional ability and quality of life in menopause which is highly relevant from both a healthcare and socio-economic perspective.

About Women’s Healthcare at Bayer
Women’s Health is in Bayer’s DNA and as a global leader in women’s healthcare Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com
Follow us on Facebook: http://www.facebook.com/bayer
Follow us on LinkedIn: Bayer | Pharmaceuticals

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References:

1 Simon JA, Anderson RA, Ballantyne E, Bolognese J, Caetano C, Joffe H, Kerr M, Panay N, Seitz C, Seymore S, Trower M, Zuurman L, Pawsey S. Efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms: a dose-finding clinical trial (SWITCH-1). Menopause. 2023 Mar 1;30(3):239-246.

2 Trower M, et al. Effects of NT-814, a dual neurokinin 1 and 3 receptor antagonist, on vasomotor symptoms in postmenopausal women: a placebo-controlled, randomized trial. Menopause: The Journal of The North American Menopause Society. 2020; 27 (5): 498-505.

Contact for global media inquiries:
Katja Wiggers, phone +49 30 221541614
Email: katja.wiggers@bayer.com

Contact for US media inquiries:
Courtney Ambrosi, phone 1 (908) 798-1107
Email: courtney.ambrosi@bayer.com

Contact for investor inquiries:
Bayer Investor Relations Team, phone +49 214 30-72704
Email: ir@bayer.com
www.bayer.com/en/investors/ir-team

Jan 13
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KaNDy Therapeutics Announces Positive Phase 2b Data in Post-Menopausal Women with its Lead Non-Hormonal Product NT-814

By KaNDy Therapeutics, Press Release
Press Release.

 

  • Phase 2b dose range finding study showed rapid and highly significant reductions in the frequency of hot flashes (primary endpoint) for the full 12-week treatment period~
  • Reduction in hot flashes was associated with statistically significant improvements in quality of life, mood and sleep – all key secondary endpoints~
  • All doses of NT-814 were well tolerated during the study, demonstrating a safety profile that supports progression to Phase 3

Stevenage, UK, 13 January 2020 – KaNDy Therapeutics, a UK clinical-stage biotech company, today announces positive data from the Phase 2b “SWITCH-1” clinical trial with its lead non-hormonal drug candidate, NT-814, for the treatment of symptoms of the menopause.

Following on from the clear benefits NT-814 demonstrated in the Phase 2a RELENT-1 study, the SWITCH-1 trial provides further compelling evidence that NT-814, a first in class, once-daily, oral neurokinin-1,3 receptor antagonist, can produce a rapid and marked reduction in the most troublesome and frequent symptoms of the menopause, hot flashes and night sweats (vasomotor symptoms). The clinical relevance of the marked improvements shown on the vasomotor symptom endpoints was supported by highly statistically significant improvements across patient reported assessments of quality of life, mood and sleep.

The SWITCH-1 study was a randomised, double-blind, placebo-controlled trial conducted in the US, UK and Canada.  One hundred and ninety-nine women experiencing at least 7 moderate or severe hot flashes/flushes (HF) per day were recruited into the study and randomised to receive one of four doses of NT-814 or placebo. Treatment with NT-814 once daily for 12 weeks at the most effective dose evaluated resulted in:

•    Statistically significant reductions compared to placebo in average hot flash frequency (primary endpoint), starting during the first week of treatment and continuing throughout the 12-week treatment period. Least squares mean reductions in average hot flash frequency were -6.7 for NT-814 vs -2.7 for placebo at week 4, and -7.8 vs -4.7 at Week 12 (p<0.0001 and p=0.0092, respectively).

•    Marked improvements in all key secondary endpoints: improved quality of life was shown by highly    significant improvements over placebo in the MenQoL menopause-specific quality of life scores, benefits on mood were demonstrated by significant improvements in the Beck Depression Inventory (II), and improved quality of sleep  was shown by statistically significant improvements compared to placebo in the Pittsburgh Sleep Quality Index scores.

•    NT-814 was well tolerated across the dose range with a safety profile that supports progression to Phase 3.

Dr. James A. Simon, Clinical Professor of Reproductive Endocrinology & Infertility at George Washington University, and the study’s Lead Investigator, commented:

“These top-line results of the SWITCH-1 study are very exciting. They demonstrate that NT-814, a truly novel therapy, offers a rapidly effective, non-hormonal approach to treating menopausal hot flashes and night sweats, debilitating symptoms of menopause. Unique to this trial, patients also reported improvements in quality of life, mood and sleep with NT-814.”

Dr Mary Kerr, Co-Founder and CEO KaNDy Therapeutics, said:

“The SWITCH-1 study started in November 2018, and so we are excited to share such positive results on schedule. The data confirms and validates Phase 2a observations, providing more evidence that neurokinins are fundamental to sex hormone biology and the pathophysiology of the menopause, resulting in almost immediate symptom relief. The Company looks forward to presenting these data at future scientific meetings and discussing it with regulatory agencies in advance of progressing the compound into pivotal registration studies.”

For more information, please contact:

KaNDy Therapeutics
Email: info@kandytherapeutics.com

Consilium Strategic Communications
Mary-Jane Elliott/ Lindsey Neville/ Carina Jurs
Tel: +44 (0) 20 3709 5700
KaNDyTherapeutics@consilium-comms.com

About the SWITCH-1 Study: The Phase 2b SWITCH-1 study was a randomised, double-blind, placebo-controlled study conducted at 25 sites in the UK, US and Canada.  It included an adaptive randomisation design that enabled the randomisation ratio to be modified to focus on doses of greatest interest based on emerging data. The study was initiated in November 2018 and completed, ahead of schedule, at the end of 2019.  A total of 199 post-menopausal women experiencing at least 7 moderate or severe HFs per week were recruited into the study and randomized to receive one of four doses of NT-814 or placebo. Study drug was taken once daily in the evening for 12 weeks. Subjects completed electronic diaries twice daily for the two weeks before and throughout treatment and underwent routine safety assessments periodically throughout the trial. Patient reported assessments of sleep, quality of life and mood were also completed periodically during study visits. Further information on the study design can be found on www.clinicaltrials.gov and full results of the study will be published at scientific congresses and in peer-reviewed journals over the coming months.

NT-814 is an orally administered, potent and selective small molecule dual antagonist of both the neurokinin-1 and 3 receptors under development by KaNDy as a therapy for a range of Women’s Health conditions. NT-814 addresses vasomotor symptoms by modulating a group of oestrogen sensitive neurones in the hypothalamus in the brain (the KNDy neurones), that in menopausal women due to the absence of oestrogen, become hyperactive and consequently disrupt body heat control mechanisms resulting in the debilitating vasomotor symptoms of hot flashes and night sweats.

KaNDy Therapeutics is a clinical-stage company focused on optimizing the potential of NT-814 in the treatment of common, chronic debilitating female sex-hormone related conditions. These conditions, such as post-menopausal vasomotor symptoms, are debilitating for women often over many years and associated with significant healthcare and economic costs. NT-814 is wholly owned by KaNDy.

Aug 29
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KaNDy Therapeutics successfully raises £25 million in a Series C financing

By KaNDy Therapeutics, Press Release
Press Release.

 

Funding to advance a breakthrough non-hormonal treatment for symptoms of the menopause, into a Phase 2b study in Q4 2018

Stevenage, UK, 29 August 2018 – KaNDy Therapeutics, a clinical-stage Women’s Health company, today announces it has successfully closed a Series C financing round, raising £25 million from new US investor Longitude Capital, and existing internationally recognised life sciences investors Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed.

The proceeds will enable KaNDy Therapeutics to advance its breakthrough non-hormonal drug candidate, NT-814, for treatment of multiple symptoms of the menopause, through a multi-country Phase 2b dose-ranging study due to start recruiting patients in Q4 2018 with headline results expected in late 2019.

Commenting on the financing round, Mary Kerr CEO of KaNDy Therapeutics, said:

“We are delighted by the level of enthusiasm and financial support we have received from our investors and would like to welcome Longitude Capital into the syndicate and the board of directors. Our investors and the KaNDy management team are united by the common belief that NT-814 has the potential to be a transformational treatment for the millions of women worldwide who suffer debilitating symptoms of the menopause.”

NT-814 is an orally administered once daily, potent and selective small molecule dual antagonist of both the neurokinin-1 and 3 receptors. It is being developed by KaNDy Therapeutics to provide a viable alternative to hormone replacement therapy. In June 2018, the Company announced positive data from the Phase Ib/IIa proof of concept clinical trial which showed that women who were treated with NT-814 once daily for two weeks at the most effective doses evaluated, experienced a rapid and profound reduction in two key symptoms of the menopause, namely frequency and severity of hot flashes and the number of night time awakenings

Josh Richardson, M.D., Managing Director of Longitude Capital said:

“We were very pleased to participate in this funding round.  We have been impressed with the data announced thus far, by KaNDy’s business strategy and the strong and experienced management team.  We believe NT-814 has the potential to greatly improve the quality of life of millions of women worldwide and we look forward to supporting the Company as it continues to progress this potentially transformational   candidate through the clinic towards commercialization.”

A Phase 2b study to further evaluate the safety and efficacy of NT-814 in women with bothersome post-menopausal symptoms, and to establish the optimum dose to take forward into Phase 3, is anticipated to start recruiting patients in the US, Canada and the UK in Q4 2018, with headline results expected in late 2019.

For more information, please contact:

KaNDy Therapeutics
Mary Kerr, Managing Director of KaNDy Therapeutics
Tel: +44 1438 906960
Email: info@kandytherapeutics.com

Consilium Strategic Communications
Mary-Jane Elliott/ Lindsey Neville/ Carina Jurs
Tel: +44 (0) 20 3709 5700
KaNDyTherapeutics@consilium-comms.com

About KaNDy Therapeutics
KaNDy Therapeutics is a clinical-stage company focused on optimizing the potential of NT-814 as a non-hormonal treatment for common, chronic debilitating female sex-hormone related conditions. These conditions, such as post-menopausal hot flashes, can impact womens’ quality of life for 10 years or more and are associated with significant social, healthcare and economic costs.

NT-814 is a once-a-day oral, potent and selective small molecule dual antagonist of both the neurokinin-1 and 3 receptors under development by KaNDy as a therapy for a range of Women’s Health conditions. NT-814 addresses hot flashes by modulating a group of oestrogen sensitive neurones in the hypothalamus in the brain (the KNDy neurones), that in menopausal women due to the absence of oestrogen, become hyperactive and consequently disrupt body heat control mechanisms resulting in the debilitating vasomotor symptoms of HF.

About Advent Life Sciences
Advent Life Sciences is one of Europe’s leading venture teams investing in life sciences businesses. The team consists of professionals with extensive scientific, medical and operational experience, and a long-standing track record of entrepreneurial and investment success across the UK, Europe and the US. The firm invests in a range of sectors within life sciences, principally in new drug discovery, enabling technologies and med tech. Realizations include Algeta, Avila, CardiAQ, CN Creative, EUSA and Micromet. Current investments include Acutus, Arrakis, Aura, Axonics, GMPO and NeRRe. For more information, please visit www.adventls.com.

About Forbion Capital Partners
Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands and Germany. Forbion invests in life sciences companies that are active in the pharmaceutical, as well as the medical device space. Forbion’s investment team has built an impressive performance track record since the late nineties with successful investments in over 50 companies. Forbion manages well over EUR 1 billion across ten funds. Its investors include the EIF, through its European Recovery Programme (ERP), LfA and Dutch Venture Initiative (DVI) facilities and the KFW through the ERP – Venture Capital Fondsfinanzierung facility. Forbion also operates a joint venture with BGV, the manager of seed and early stage funds focused on Benelux and Germany. www.forbion.com

About Fountain Healthcare Partners
Fountain Healthcare Partners is a life science focused venture capital fund with €176 million ($200 million) under management. Within the life science sector, specific areas of interest to Fountain include specialty pharma, medical devices, biotechnology and diagnostics. The firm deploys the majority of its capital in Europe, with the balance in the United States. Fountain’s main office is in Dublin, Ireland, with a second office in New York. For more information, please visit www.fh-partners.com.

About Longitude Capital
Longitude Capital is a private investment firm that makes venture growth investments in biotechnology and medical technology companies that seek to improve clinical outcomes, enhance quality of life and/or reduce system costs. Longitude Capital invests in both privately held and publicly traded life science companies through a variety of investment approaches. Since 2006, Longitude Capital has raised over $1.2 billion across three funds and has offices in Menlo Park, CA and Greenwich, CT. For more information, please visit www.longitudecapital.com.

About OrbiMed
OrbiMed is a leading healthcare investment firm, with $14 billion in assets under management. OrbiMed invests globally across the healthcare industry, from start-ups to large multinational corporations, utilizing a range of private equity funds, public equity funds, and royalty/credit funds. OrbiMed maintains offices in New York City, San Francisco, Shanghai, Hong Kong, Mumbai and Herzliya. OrbiMed seeks to be a capital provider of choice, providing tailored financing solutions and global team resources and support to help build world-class healthcare companies.

Sep 27
Love0

KaNDy Therapeutics launched to advance a breakthrough treatment in Women’s Health

By KaNDy Therapeutics, Press Release
Press Release.

 

First-in-class once daily NT-814 spun out of NeRRe Therapeutics into new company

Stevenage, UK, September 27th 2017 – KaNDy Therapeutics has been launched today to maximise the value of NT-814, a potential breakthrough medicine for the treatment of chronic debilitating Women’s Health conditions and is backed by internationally recognised life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed Advisors.

NT-814 is a first-in-class, once daily, dual mechanism neurokinin-1,3 receptor antagonist. The medicine is being developed as a non-hormonal alternative to hormone replacement therapy for the treatment of postmenopausal vasomotor symptoms (PMVMS). NT-814 has been spun out of NeRRe Therapeutics Holdings Ltd into KaNDy Therapeutics Ltd a separate legal entity.

KaNDy Therapeutics will advance the development of NT-814 into Phase 2b in the lead indication PMVMS while also exploring its potential in other Women’s Health conditions. All formulation, pre-clinical and clinical safety and efficacy data, and intellectual property associated with NT-814 have been transferred to the new company. KaNDy Therapeutics is led by Managing Director Mary Kerr and chaired by Iain Dukes, Venture Partner at OrbiMed Advisors. The company is based at the Stevenage Bioscience Catalyst in the UK.

NT-814 has significant potential to treat multiple debilitating Women’s Health conditions by virtue of the ability to beneficially modulate dysfunctional temperature control and reproductive hormone pathways. NT-814 has already successfully completed a Phase 2a proof of concept study demonstrating its potential to reduce the frequency and severity of PMVMS, and is now being prepared to enter an international Phase 2b study in this anchor indication.

Iain Dukes, Chairman of KaNDy Therapeutics, said,

“The formation of KaNDy Therapeutics enables us to maximise the potential of NT-814 in a range of debilitating Women’s Health conditions. We believe NT-814 is one of the few true innovations in Women’s Health in more than two decades and potentially represents a major breakthrough in areas of significant unmet medical need such as PMVMS. Mary has built up an excellent team who have made substantial progress with NT-814 and we’re looking forward to advancing this exciting new product into a Phase 2b programme.”

Professor Richard Anderson, Clinical Adviser, University of Edinburgh, commented,

“For many women, menopausal symptoms such as hot flashes are debilitating and long-lasting, and can have a major impact on quality of life. As a potential once daily alternative to HRT without the issues surrounding hormone replacement, NT-814 could bring them considerable relief.”

–ENDS–

 

For further information, please contact:

Mary Kerr, Managing Director of KaNDy Therapeutics

Tel:  +44 1438 906960
Email: info@kandytherapeutics.com

Notes for editors

About KaNDy Therapeutics
KaNDy Therapeutics is a UK based clinical-stage company focused on optimizing the potential of its unique NK-1,3 receptor antagonist NT-814 in the treatment of common, chronic debilitating female sex-hormone related conditions. NT-814 is in development initially as a non-hormonal therapy to treat moderate to severe post-menopausal vasomotor symptoms (PMVMS)).

PMVMS affect up to 75% of peri-menopausal women. Symptoms last for 1–2 years after menopause in most women, but may continue for up to 10 years or longer in others. Approximately 20% of women will have debilitating symptoms. Hot flashes are the primary reason women seek medical care at menopause. Hot flashes not only disturb women at work and interrupt daily activities, but also have a detrimental effect on sleep. Post-menopausal vasomotor symptoms are experienced by millions of women globally on a daily basis.

The company is led by an experienced management team including Dr Mary Kerr (Managing Director), formerly SVP and Global Franchise lead at GSK and Dr Mike Trower (CSO/COO), formerly VP & Head of the External Drug Discovery Group in the Neurosciences CEDD at GSK and Dr Steve Pawsey (CMO) formerly at Circassia and Vernalis.

KaNDy Therapeutics was spun out of NeRRe Therapeutics in September 2017, and is backed by internationally recognised life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed Advisors. KaNDy Therapeutics is based at Stevenage Bioscience Catalyst. You can find more information about KaNDy Therapeutics at www.kandytherapeutics.com.