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NovaBiotics Highlights Importance of a Co-ordinated Approach to Antimicrobial Resistance

NovaBiotics Highlights Importance of a Co-ordinated Approach to Antimicrobial Resistance

Aberdeen, UK – 7 June 2016 – Dr Deborah O’Neil, CEO of NovaBiotics Ltd (“NovaBiotics” or the “Company”), the Aberdeen-based clinical stage biotechnology company, today stated that a multi-attack and multi-strain approach to the development of new antibiotics is the only way to meet the rising challenge of AMR.

Dr O’Neil was speaking at the ‘Focus on Anti-Infectives: Innovation for AMR’ workshop alongside companies such as Polyphor, RedX, and VICALat, at this year’s BIO International Convention in San Francisco. The workshop brought together those involved in all aspects of AMR, including industry large and small, universities, investors, expert scientific and business support, funders, policy makers and regulatory bodies.

The event was hosted by the Innovative Medicines’ Initiative (IMI), The Wellcome Trust-funded Community for Open Antimicrobial Drug Discovery and the IMI-funded European Biotechnology Networks ENABLE project. In key note speeches, they highlighted the global tools available to support the development of novel anti-infectives.

“While efforts are being made to develop new antibiotics, unless a co-ordinated approach is taken, the problem of resistance will always be an issue across fungal, bacterial and biofilm forms of infection,” said Dr O’Neil.

“We must act on infections already resistant to other antimicrobials with multiple modes of action and multi-strain attack to mitigate the evolution of resistance.  In parallel, we need to combine novel anti-infectives with resistance breakers that can attack infections from all sides. Addressing the issue now and planning for the future is crucial.”

Notes To Editors

NovaBiotics Limited (“NovaBiotics” or the “Company”) is a private, UK-based anti-infectives focused biopharmaceutical company.  The Company has an advanced product portfolio of antimicrobial assets targeting large and important markets with significant unmet clinical needs. These include Lynovex, a novel multi-active orphan therapy for cystic fibrosis, Novexatin for the treatment of onychomycosis, a potential blockbuster outlicenced to Taro Pharmaceuticals, and Novamycin, a novel rapid acting antifungal for aspergillosis and other life-threatening yeast and mould infections. The Company is also developing earlier stage compounds from its proprietary antimicrobial peptide rational drug design platform.

Lynovex is a novel, highly differentiated therapy for the treatment of CF-associated lung disease.  The CF market is estimated at $6 billion and there is a clear need for effective treatment of the symptoms of CF-associated lung disease, the most critical clinical manifestation of this orphan disease.  Lynovex addresses the key treatment challenges through its unique triple mode of action: Antibacterial - addressing both current (e.g. Pseudomonas) and emerging/antibiotic insensitive (e.g. NTM and Burkholderia Spp) pathogen; Mucolytic - clear superiority to approved mucolytic therapeutics; Antibiofilm - addressing the key challenge of mucus build up with the airways of CF patients.

Efficacy has been demonstrated through in vitro study, ex vivo (sputum) and a clinical phase IIa study. In addition, the Company has demonstrated that Lynovex dramatically enhances the effect of existing anti-infective drugs.  To that end, Lynovex is intended for use alongside existing standard of care therapies (SOCT) and to treat all CF disease genotypes. It is not a mutation-specific, CFTR-targeting intervention.
NovaBiotics is developing two different formulations of the same active ingredient: Oral for CF exacerbations; due to commence a US / EU registration study 2016 and Inhaled for chronic CF therapy; due to commence a clinical POC study 2016/2017.  

This topical therapy is a step-change in the treatment of fungal nail infection (onychomycosis), a $6 billion market and affecting 12% of the global population. Based on the results of studies to date, Novexatin is the first topical agent to deliver high cure rates and rapid cosmetic benefits with only 4 weeks of treatment vs. 48 weeks for the existing topical treatments (including Jublia and Kerydin).  Novexatin’s placebo-like safety profile has enabled dosing of all nails, which the Company believes is important in delivering a long lasting clinical benefit.  A large phase IIb study is underway and results are expected in 2017.

Novexatin is being developed with NovaBiotics’ licensing and co-development partner, Taro pharmaceuticals and is currently being further investigated in a Taro-led large PhIIb clinical study.

Closely related to Novexatin in molecular architecture (and therefore de-risked) but with a distinct spectrum of activity, Novamycin is a first-in-class antifungal peptide being developed to target life threatening yeast and mould infections; predominantly invasive pulmonary aspergillosis, but also candidaemia, oral pharyngeal candidiasis, vulvovaginal candidiasis, cryptococcosis, respiratory fungal infections associated with CF and murcomycoses. The Novamycin invasive pulmonary aspergillosis programme is most advanced with compelling in vitro and in vivo data to support Novamycin’s application in this poorly served, life-threating condition.

Proprietary Antimicrobial Peptide Rational Drug Design Platform
The Company’s proprietary drug discovery platform (from which Novexatin and Novamycin have been derived) is based upon re-engineering endogenous antimicrobial peptides (“AMP”); naturally occurring antifungal and antibacterial agents that form the body’s first line of defence against infection. This rational drug design platform enables the development of smaller, simpler and therapeutically viable molecules, and is validated by NovaBiotics’ Novexatin and Novamycin drug candidates. The Company’s preclinical antibacterial candidate, Novarifyn®, is the next compound derived from the platform to be developed and is due to enter clinical development in 2018.

Issued for and on behalf of NovaBiotics by Instinctif Partners.

For more information please contact:
Dr. Deborah O’Neil - CEO & CSO
+44 (0) 1224 711377

For media enquiries:
Instinctif Partners

Gemma Howe / Rosanna Forrest
Tel: +44 (0) 20 7457 2020

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