F2G

Press Release.

First Clinical Trial for NeRRe Therapeutics

Press Release:

Start of Phase II study of neurokinin-1 receptor antagonist orvepitant for intense pruritus induced by epidermal growth factor receptor inhibitors

First Clinical Trial for NeRRe Therapeutics

Stevenage, UK, 23 January 2014. NeRRe Therapeutics Ltd, which is focused on the development of neurokinin (NK) receptor antagonists for a range of indications, is pleased to announce the start of a Phase II study of the novel NK-1 receptor antagonist orvepitant. The proof-of-concept study, results of which are expected in 2015, is investigating orvepitant’s effectiveness as a treatment for the intense pruritus (itch) associated with epidermal growth factor receptor inhibitor (EGFRi) anticancer therapies. The itch intensity experienced by patients can be so severe that their EGFRi dose must be reduced or the treatment withdrawn; also pruritus along with rash has a significant effect on quality of life1.

The RELIEVE-1 trial is a randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability and efficacy of two daily dose levels of oral orvepitant on EGFRi-induced intense pruritus in oncology subjects. Its primary endpoint is the difference between orvepitant and placebo in reducing the intensity of pruritus over 4 weeks, as measured on a subject-recorded numerical rating scale. RELIEVE-1 is being undertaken in 15 clinical sites in Italy, with Dr Bruno Vincenzi from Università Campus Bio-Medico di Roma as lead investigator. Dr Vincenzi and his colleagues at the centre have pioneered the use NK-1 antagonists as anti-pruritics in this setting2. Chemistry, manufacturing and control support for RELIEVE-1 is being provided by Aptuit (Verona) Srl, with clinical operations assistance from the CRO Cromsource.

Dermatologic adverse events such as pruritus are a common feature of targeted anti-cancer therapies, with incidence of this symptom induced by EGFRia drugs in clinical trials ranging from 14.6% to 54.9% depending on the specific agent3. Open-label studies in patients suffering from refractory chronic pruritus have indicated that NK-1 receptor antagonism can provide rapid and highly effective relief as well as significantly improving quality of life.2,4,5,6

Dr Mike Trower, Co-founder & Chief Operating Officer of NeRRe Therapeutics said:  ‘We are very pleased to announce the start of RELIEVE-1, NeRRe’s first clinical trial, in this important area of unmet medical need. There is a strong rationale and a growing body of clinical evidence supporting the potential of orvepitant as an anti-pruritic for this devastating symptom commonly associated with EGFRis. Given its known effects on mood and sleep, orvepitant may also provide additional benefits for patient well-being.’

Dr Emiliangelo Ratti, NeRRe Therapeutics Co-founder added: ‘The intense pruritus induced by EGFRis can lead to significant suffering and poor quality of life, and we believe that a treatment for this troubling side effect would be welcomed by cancer patients and supportive care doctors alike. A successful study of orvepitant in this indication would provide further evidence of the broad therapeutic potential of the NK-1 receptor antagonist mechanism which NeRRe is exploiting in its pipeline.’

–ENDS–

a This includes monoclonal antibodies that target the extracellular domain of EFGR, small molecule tyrosine kinase (TK) inhibitors, and small molecule dual TK inhibitors.

For more information about NeRRe Therapeutics, please contact:
Dr Mike Trower, Chief Operating Officer
Tel: +44 (0) 1438 906960
Email:  info@nerretherapeutics.com

About NeRRe Therapeutics
NeRRe Therapeutics was formed in December 2012 and is focussed on the development of a portfolio of NK receptor antagonists acquired from GlaxoSmithKline (GSK), which have therapeutic potential in a broad range of indications. NeRRe Therapeutics was co-founded by Drs Emiliangelo Ratti and Mike Trower, both of whom are both former senior leaders of neurosciences drug discovery at GSK with intimate knowledge of the transferred assets and the neurokinin receptor system field. In 2012 NeRRe Therapeutics raised £11.5 million ($18.4 million) in Series A financing from two leading European financial institutions, Novo A/S (www.novo.dk/ventures) and Advent Life Sciences (www.adventventures.com), who are represented by Dr Martin Edwards (Chairman) and Dr Kaasim Mahmood respectively on the company’s Board.

NeRRe (www.nerretherapeutics.com) is based at the state-of-the-art Stevenage Bioscience Catalyst (www.stevenagecatalyst.com), the UK’s first open innovation bioscience campus.

About Orvepitant
Orvepitant is a ‘novel generation’ brain penetrant, selective and potent, small molecule NK-1 receptor antagonist7 that features high receptor occupancy and full and long lasting (≥24hrs) central NK-1 receptor occupancy8. It has previously completed extensive safety and toxicology studies to support its clinical development; and it has already demonstrated a positive antidepressant effect in a Phase II clinical study together with beneficial effects on sleep8.

References:
1.    Rosen AC et al. Am J Clin Dermatol. (2013), 14(4):327-33
2.    Santini D et al. Lancet Oncol. (2012), 13(10):1020-4
3.    Ensslin CJ et al. J Am Acad Dermatol. (2013), 69(5):708-20
4.    Duval A, Dubertret L. N Engl J Med. (2009), 1;361(14):1415-6
5.    Ständer S et al. PLoS One. (2010), 5(6):e10968
6.    Torres T et al. J Am Acad Dermatol. (2012), 66(1):e14-5
7.    Di Fabio R et al. Bioorg Med Chem. (2013), 21(21):6264-73
8.    Ratti E et al. J Psychopharmacol. (2013), 27(5):424-34

NeRRe Therapeutics Press Release here:

Press Release.

March 11th 2013

F2G Ltd. Appoints Ian Nicholson as Chief Executive Officer Manchester

F2G Ltd, the UK-based antifungal drug discovery and development company, today announced the appointment of Ian Nicholson to the position of CEO and to the Board of Directors . Ian has over 25 years of international experience in management and transactions within the life sciences sector. He is currently, and will remain, an Operating Partner of London-based Advent Life Sciences LLP. Previously he spent eight years as CEO of the privately held Oncology R&D company, Chroma Therapeutics Limited. Before that he was senior vice president for business development at UK biotechnology company Celltech Group, and has worked extensively in licensing, M&A, and market development in the UK, Europe and the US. Ian holds a BSc (Hons) from University College London and an MBA from Boston University.

Dr Richard White, Executive Chairman of F2G, commented

‘We are delighted to welcome such an experienced executive to lead the company, and I look forward to working closely with him.’

Dr. White will revert to his former role of Non-Executive Chairman. Ian Nicholson added

‘I am excited to join F2G at this critical stage and lead the company in the successful development of an important first-in-class drug to treat Aspergillosis, an area of high unmet medical need.’

About F2G Ltd: Based in Manchester, UK, F2G Ltd is dedicated to the discovery and development of new and clinically superior drug classes to treat life-threatening systemic fungal infections in at-risk patient populations. This is a growing health risk for which there are currently limited treatment options and for which demand is increasing globally Market growth is expected to increase with the emergence of new clinical indications in allergies and asthma. For more information visit www.f2g.com

Press Release.

Manchester, UK, Sept 5th 2012 – F2G Limited, an antifungal drug discovery and development company, today announced the completion of a $30 million equity financing round in which two new investors (Advent Life Sciences and Novartis Bioventures) joined the existing syndicate (Sunstone Capital, Merifin Capital, K Nominees, and Astellas Venture Fund). These funds will be used to select a clinical candidate from the F3 series of advanced preclinical analogs and proceed to first in man studies. The F3 series represents a proprietary group of compounds with highly potent and selective activity against Aspergillus species and other moulds, which act via a totally novel mechanism. Aspergillus infections are a serious threat in immune-compromised patient populations and result in a high rate of mortality even with the most effective treatment currently available. Dr Richard White, chairman of F2G, commented,

“We are delighted to welcome two top tier investors into F2G. We now have a first class international syndicate, including the venture arms of two major pharmaceutical companies”.

Shane Kelly, previously the CEO, is leaving the company to pursue another opportunity. Dr White will assume the expanded role of Executive Chairman and noted

“We would all like to thank Shane for his tireless and steadfast management of the company over the last 10 years and for bringing us to this successful juncture. We wish him well in his new venture”

Dr Raj Parekh of Advent and Dr Anja König of Novartis Venture Funds will both be joining the Board of F2G. Raj Parekh, General Partner at Advent said, “The F2G molecules show a compelling and novel profile and have the genuine potential to be first- and best- in-class agents for the treatment of invasive aspergillosis, which remains a serious unmet medical need. We look forward to working with Richard and the team to bring these molecules to an early clinical evaluation.”

About F2G Ltd:

Based in Manchester, UK, F2G Ltd is dedicated to the discovery and development of new and clinically superior drug classes to treat life-threatening systemic fungal infections in at-risk patient populations. The antifungal market is currently estimated at over 6 billion dollars annually and is growing steadily year on year. Market growth is expected to increase with the emergence of new clinical indications in allergies and asthma. The company has impressive internal capabilities, employing a core team of scientists with a unique understanding of the antifungal arena, supported by an experienced management team. For more information visit www.f2g.com