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Aug 08
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Levicept Announces Positive Results of Phase II Trial of novel Neurotrophin-3 Inhibitor, LEVI-04

By Levicept, Press Release, Private Companies
Press Release.

 

Levicept Announces Positive Results of Phase II Trial of novel

Neurotrophin-3 Inhibitor, LEVI-04, for the Treatment of Patients with Moderate to Severe Osteoarthritis

  • All primary and secondary efficacy endpoints met – significant analgesia across all measures for all doses
  • Well tolerated with no increase in incidence of rapid joint deterioration compared to placebo
  • First in class novel biologic under development as non-addictive pain treatment

Sandwich, UK – 6 August 2024 – Levicept Ltd, a biotechnology company focused on the development of LEVI-04, a first-in-class treatment for osteoarthritis and other pain indications, today announces positive results from its Phase II trial of LEVI-04 a novel and first in class neurotrophin-3 (NT-3) inhibitor, showing that LEVI-04 was highly effective and well tolerated.

The multiple arm, multicentre, randomized, double-blind, placebo-controlled, Phase II study enrolled more than 510 participants with pain and disability due to osteoarthritis of the knee (ClinicalTrials.gov ID: NCT05618782). The trial was conducted at sites across Europe and in Hong Kong, led by Professor Philip Conaghan MD from the University of Leeds and Leeds Teaching Hospitals NHS Trust, UK.

LEVI-04 demonstrated significant differences to placebo at Week 17 for all primary and secondary endpoints for all doses evaluated:

  • The primary endpoint was WOMACi pain assessment (change from baseline at Week 17). The mean reduction in WOMAC pain score from baseline was greater than 50% for all three doses of LEVI-04 and all statistically different to placebo.
  • Secondary endpoints were WOMAC subscales of function and joint stiffness, patient global assessment and daily pain scores and all statistically different to placebo.

Standard safety monitoring plus peripheral nervous system assessments showed LEVI-04 to be well tolerated. There was no increase in incidence of rapidly progressive osteoarthritis (RPOA) as measured via detailed, closely examined, radiographic analysis.

Levicept intends to submit full results for publication in a peer-reviewed journal.

Professor Philip Conaghan MD, Director NIHR Leeds Biomedical Research Centre and Principal Investigator said, “These results are truly exceptional and clinically meaningful in their extent. Safe and effective pain management is of critical importance in arthritis with existing treatments limited by adverse effects, addiction liabilities and poor efficacy. In this trial, LEVI-04 has demonstrated the potential to safely harness the analgesic properties of neurotrophin-3 inhibition and offer a vital new treatment option to millions of patients in huge need. If Phase III trials replicate these results, LEVI-04 would represent a major break-through for osteoarthritis treatment, and with substantial potential in other pain indications.”

Globally, 595 million people had osteoarthritis (OA) in 2020, affecting 7.6% of the population and making it the most common form of arthritisii. It is estimated that the market opportunity for drugs that treat OA is worth in excess of $10 billioniii.

Simon Westbrook, founder and CSO of Levicept, “The discovery of LEVI-04 harnessed the power of

evolution to design a molecule that supplements the endogenous NT regulator, soluble p75NTR. LEVI- 04 provides analgesia via inhibition of neurotrophin-3, while avoiding the use-limiting side effects of anti-NGF antibodies, including rapidly progressive of osteoarthritis. LEVI-04 retains the important trophic effects of the neurotrophins, including joint re-modelling. We want to thank all the clinicians and trial participants and hope that the results bring the prospect of a new treatment for them and many others.”

Kevin Johnson, Chairman of Levicept and Partner at founding investor Medicxi said, “The results from this robust and large-scale Phase II fully validate the belief of Levicept’s founders and investors that LEVI-04 could be a genuine breakthrough in the treatment of osteoarthritis. They also leave Levicept exceptionally well-positioned to consider the next strategic options to advance LEVI-04’s development.”

LEVI-04 is a proprietary p75 neurotrophin receptor fusion protein (p75NTR-Fc) that provides analgesia via inhibition of NT-3 activity and returns neurotrophin homeostasis by supplementing the endogenous p75NTR binding protein to scavenge excess neurotrophins present in chronic pain states.

ENDS

Levicept

Eliot Forster, CEO – eliot@levicept.com

Media Enquiries Charles Consultants

Sue Charles – Sue@charles-consultants.com +44 (0)7968 726585

Chris Gardner – Chris@CGComms.onmicrosoft.com +44 (0)7956 031077

About Levicept – www.levicept.com

Levicept Ltd is a UK-based biotechnology company developing the first in a new class of novel, safe

and efficacious biological therapies, LEVI-04 [p75NTR-Fc], for the treatment of osteoarthritis and chronic pain. LEVI-04 inhibits NT-3, one of the neurotrophin family of proteins. LEVI-04 has completed a Phase II clinical trial in more than 500 patients with osteoarthritis. It is estimated that the market opportunity for drugs that treat osteoarthritis is worth in excess of $10 billion. LEVI-04 was discovered by Levicept’s founder, Simon Westbrook. Levicept’s investors include Medicxi, Advent Life Sciences, Gilde Healthcare and Pfizer Ventures.

Follow us on LinkedIn – https://www.linkedin.com/company/levicept-ltd

i The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale – a recognised standard

pain scale

ii https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(23)00163-7/fulltext

iii Global Neurotrophins Market- Analysis, Size, Forecast 2033 (futuremarketinsights.com)

Dec 13
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Levicept Completes Recruitment in Phase II Clinical Trial of Neurotrophin Modulator, LEVI-04

By Levicept, Press Release, Private Companies
Press Release.

 

Levicept Completes Recruitment in Phase II Clinical Trial of Neurotrophin Modulator, LEVI-04
Study of Novel Biological Agent for Chronic Pain in Patients with Osteoarthritis

Sandwich, UK – 13 December 2023 – Levicept Ltd, a biotechnology company focused on the development of LEVI-04, a first-in-class treatment for chronic pain indications, today announces it has completed recruitment in its Phase II clinical trial of LEVI-04, a novel neurotrophin-modulating biological agent. Top line data are expected to be announced in late first half of 2024.

The multiple arm, multicentre, prospective, randomized, double-blind, placebo-controlled, Phase II study enrolled more than 500 participants with pain due to osteoarthritis of the knee (ClinicalTrials.gov ID: NCT05618782). The trial was designed to evaluate the efficacy, safety and tolerability of five, monthly, infusions of LEVI-04 as compared to placebo in participants with radiographic and symptomatic knee osteoarthritis. The trial is being conducted at sites across Europe and in Hong Kong, led by Dr Philip Conaghan at The School of Medicine, University of Leeds, UK.

LEVI-04 modulates the neurotrophin pathway that is clinically proven to provide effective analgesia in a range of indications and is designed to minimise use-limiting side effects of anti-NGF antibodies, including rapid progression of osteoarthritis. It is a proprietary p75 neurotrophin receptor fusion protein (p75NTR-Fc).

LEVI-04 is designed to deliver neurotrophin homeostasis by providing a reversible binding protein which scavenges excess neurotrophins present in chronic pain states. It operates across four receptor pathways in the neurotrophin system and is designed to supplement the existing endogenous p75NTR binding protein and returning normal neurotrophin function. Importantly, unlike anti-NGF antibodies which ablate NGF signalling as they bind irreversibly to NGF, LEVI-04 provides analgesia while maintaining the neurotrophin function required for cartilage and bone repair.

Phase I data on LEVI-04 demonstrated a favourable safety, tolerability and pharmacokinetic profile. Analysis of biomarkers indicated target engagement and provided early supporting evidence of efficacy / proof-of-concept.

Dr Philip Conaghan, Principal Investigator said, “Safe and effective pain management is a critical need in arthritis with existing treatments limited by addiction-liabilities, adverse effects and poor efficacy. While the potential of the neurotrophin pathway to provide effective pain relief is recognised, safety issues have significantly hampered development. LEVI-04 offers a highly promising new approach to safely harness the analgesic potential of neurotrophin modulation and we look forward to the trial results next year.”

Simon Westbrook, founder and CSO of Levicept, and study director said, “The fact we completed recruitment in this large-scale Phase II in under a year is testament to physicians’ interest in our programme and patients’ pressing need for new treatment options for their chronic pain.”

LEVI-04 was originally discovered at Pfizer UK by Levicept’s founder, Simon Westbrook who subsequently acquired the asset. Levicept recently announced the appointment of experienced biotech executive Eliot Forster as CEO to help steer the best path for the further development of LEVI-04 and its ultimate commercialisation.
ENDS

Levicept
Eliot Forster, CEO – info@levicept.com

Media Enquiries
Charles Consultants
Sue Charles – Sue@charles-consultants.com +44 (0)7968 726585
Chris Gardner – Chris@CGComms.onmicrosoft.com +44 (0)7956 031077

About Levicept – www.levicept.com

Levicept Ltd is a UK-based biotechnology company developing a novel, safe and efficacious biological therapy (LEVI-04 [p75NTR-Fc]) for the treatment of chronic pain. LEVI-04 is currently in phase II in patients with osteoarthritis of the knee. LEVI-04 modulates the neurotrophin pathway, clinically proven to provide effective analgesia in a range of indications and is designed to minimise use-limiting side effects of anti-NGF antibodies, including rapid progression of osteoarthritis. It is estimated that the market opportunity for drugs that modulate neurotrophins, developed to a high safety standard, is worth in excess of $10 billion. LEVI-04 was originally discovered at Pfizer by Levicept’s founder, Simon Westbrook who subsequently acquired the asset. Levicept’s investors include Medicxi, Advent Life Sciences, Gilde Healthcare and Pfizer Ventures.

Follow us on LinkedIn – https://www.linkedin.com/company/levicept-ltd

Nov 30
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Levicept Appoints Eliot Forster as CEO

By Levicept, Press Release, Private Companies
Press Release.

 

Levicept Appoints Eliot Forster as CEO

Leadership Team Strengthened as Clinical Development of LEVI-04 a Novel Neurotrophin Modulator for Osteoarthritis and Chronic Pain Advances

Sandwich, UK – 30 November 2023 – Levicept Ltd, a biotechnology company focused on the development of LEVI-04, a first-in-class treatment for chronic pain indications, today announces the appointment of Eliot Forster as CEO. Founder and inventor of LEVI-04, Simon Westbrook, is to take the role of CSO.
Eliot brings more than thirty years of experience in the biotech and pharmaceutical sectors, with considerable experience in deal making and finance. His appointment strengthens the Levicept leadership team as the company matures through clinical development of LEVI-04 towards the future advancement and its ultimate commercialisation.

LEVI-04 modulates the neurotrophin pathway, that is clinically proven to provide effective analgesia in a range of indications and is designed to minimise use-limiting side effects of anti-NGF antibodies, including rapid progression of osteoarthritis. Having successfully completed a phase I trial in 2021, Levicept is advancing LEVI-04, a proprietary p75 neurotrophin receptor fusion protein (p75NTR-Fc), a once-a-month injectable for the treatment of osteoarthritis and chronic pain, through a 500+ patient phase II clinical trial.

Eliot was most recently CEO of F-star (NASDAQ:FSTX), a clinical-stage, NASDAQ-listed biotech that was acquired by inovX Pharma limited in March 2023. Prior to this he was CEO of Immunocore (NASDAQ:IMCR), and previously led the clinical development of several pain medicines, including the COX-2 inhibitors. His early career was at GSK and Pfizer. Alongside his role at Levicept, currently he serves on the Boards of Tessellate BIO, Avacta Group (AIM:AVCT), Ochre Bio, Protalix Biotherapeutics (AMEX:PLX), and Immatics NV (NASDAQ:IMTX).

Eliot Forster, CEO of Levicept, said, “The safe and effective management of chronic pain remains a critical need in medicine. While existing treatments can be effective their use is often limited by adverse effects, addiction-liabilities, or poor pain control. LEVI-04 has the potential to effectively target the clinically proven neurotrophin pain pathways, but with a superior safety profile. I very much look forward to working with Simon and his team to advance this important programme to its completion.”

Kevin Johnson, Chairman of Levicept and Partner at investor Medicxi said, “As a highly focused single asset company, Levicept has made excellent progress with LEVI-04 though phase I and ongoing phase II studies. With data to date looking very promising, I am delighted to welcome Eliot to the company at an important time for the company, to work with Simon and the team to help steer the best path for the further development of LEVI-04.”

Simon Westbrook, founder and CSO of Levicept said, “Eliot’s appointment underlines the potential we see in LEVI-04 and the near-term opportunities on the back of the pre-clinical and clinical work we have undertaken. With our phase II trial nearing completion, we can now benefit from Eliot’s experience and networks to ultimately maximise the chances of LEVI-04 reaching patients and offering a new, safe treatment for chronic pain.”

It is estimated that the market opportunity for drugs that modulate neurotrophins, developed to a high safety standard, will be worth in excess of $10 billion by 2033.

Levicept
Eliot Forester, CEO – info@levicept.com

Media Enquiries
Charles Consultants
Sue Charles – Sue@charles-consultants.com +44 (0)7968 726585
Chris Gardner – Chris@CGComms.onmicrosoft.com +44 (0)7956 031077

About Levicept – www.levicept.com

Levicept Ltd is a UK-based biotechnology company developing a novel, safe and efficacious biological therapy (LEVI-04 [p75NTR-Fc]) for the treatment of chronic pain. LEVI-04 is currently in phase II in patients with osteoarthritis of the knee. LEVI-04 modulates the neurotrophin pathway, clinically proven to provide effective analgesia in a range of indications and is designed to minimise use-limiting side effects of anti-NGF antibodies, including rapid progression of osteoarthritis. It is estimated that the market opportunity for drugs that modulate neurotrophins, developed to a high safety standard, will be worth in excess of $10 billion by 2033. LEVI-04 was originally discovered at Pfizer by Levicept’s
founder, Simon Westbrook who subsequently acquired the asset. Levicept’s investors include Medicxi, Advent Life Sciences, Gilde Healthcare and Pfizer Ventures.

Follow us on LinkedIn – https://www.linkedin.com/company/levicept-ltd