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NovaBiotics Ltd Release: Initiation Of A Phase IIa Clinical Study For Lynovex® In Cystic Fibrosis



6/25/2014 9:06:58 AM

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Aberdeen, UK – 25 June 2014 – NovaBiotics Ltd, the Aberdeen-based speciality biotechnology company (“NovaBiotics” or the “Company”), today announced the initiation of an open label/single arm Phase IIa clinical study to assess the safety, tolerability, pharmacokinetics and initial evidence of efficacy of orally-dosed Lynovex®. The Phase IIa trial will be undertaken in collaboration with the University of Aberdeen and NHS Grampian.

Lynovex® is a candidate therapeutic for cystic fibrosis and has unique multi-functionality. Lynovex® has the potential to break down the mucus produced in the airways of CF patients and at the same time, has been shown to kill the bacteria responsible for the recurrent respiratory infections in cystic fibrosis. Furthermore, Lynovex® disrupts and prevents the biofilms which these bacteria typically form in the cystic fibrosis airway. By functioning in this way, Lynovex® could improve lung function and halt or prevent long term damage or degeneration of respiratory tissues in CF patients. Lynovex® has been designated as an Orphan Drug by the EMA.

The trial follows the generation of very promising results from a study in which the antibacterial and mucolytic impact of Lynovex® was determined against sputum samples from cystic fibrosis patients. The Phase IIa study will determine levels of Lynovex® in the blood and sputum of cystic fibrosis patients after it has been administered in tablet form and will monitor levels of bacteria in sputum, lung function and weight as well as general health and quality of life parameters. Results from the trial are expected to be announced H2 2014 and are part of the Company’s wider plan to develop orally administered Lynovex® as an intervention in acute exacerbations of cystic fibrosis.

Dr Deborah O’Neil, CEO of NovaBiotics, said: “There has been significant drive from the patients to run this trial and tremendous support from all the collaborators, the University of Aberdeen, Health Science Scotland, NHS Grampian and of course, the Cystic Fibrosis Trust. Each and every one of the stakeholders in this study, the patients especially, agree that cystic fibrosis is an orphan disease that remains totally underserved by current treatments. Everyone involved in Lynovex’s clinical development wants to help deliver new and effective ways to treat this disease. We believe Lynovex® could provide significant benefit to the majority of cystic fibrosis patients and we eagerly anticipate the results of this trial and to be able to progress the product further through an expedited regulatory process towards eventual clinical use.”

Professor Graham Devereux of the University of Aberdeen and Consultant for NHS Grampian, one of the specialists at Aberdeen Royal Infirmary who looks after patients with Cystic Fibrosis, said “The bacteria causing problems in Cystic Fibrosis are all too often highly resistant to current antibiotics, by reducing antibiotic resistance Lynovex® could make a real difference to all patients with Cystic Fibrosis, this is rather exciting.”

Dr Janet Allen, Director of Research and Care at the Cystic Fibrosis Trust said: “It is exciting to see how the Cystic Fibrosis Trust’s partnerships with industry are helping to deliver new and successful ways to help treat this disease and we all look forward to seeing the results of the Phase 2IIa trial in due course. By engaging with partners in research and industry the Trust believes it can help speed up the development of new therapies and treatments such as Lynovex® to further the quality and length of life of all people who have cystic fibrosis.”

About NovaBiotics

NovaBiotics Ltd is a clinical-stage biotechnology company focused on the design and development of first-in-class anti-infectives for difficult-to-treat, medically unmet diseases. A leading innovator in the anti-infectives space, the Company’s robust pipeline includes clinical stage antimicrobials that have been derived from NovaBiotics’ proprietary anti-infective peptide platform and a "mini biologic” antibacterial-mucolytic compound (Lynovex®). NovaBiotics lead product, NP213 (Novexatin®) is being developed as a topical treatment for fungal nail infections (onychomycosis), a condition that affects more than 10% of the global population. In 2014, NP213 will undergo evaluation in Phase IIb clinical trials with the Company’s co-development partner, Taro Pharmaceuticals. NovaBiotics is also developing NM001 (Lynovex®), an orphan drug treatment for cystic fibrosis. NM001 has a unique dual antibacterial-mucoactive mode of action that kills bacteria, disables biofilms and disrupts excess mucous produced in the airways of patients with cystic fibrosis (and other chronic respiratory diseases). NM001 is being evaluated in Phase IIa clinical trials as an oral treatment for cystic fibrosis and is also being formulated for inhalation to enable longer term, more targeted delivery of the drug. An exciting pipeline of preclinical stage drug candidates is already demonstrating significant promise. These include NP339 (Novamycin®), an antifungal peptide agent against Candida spp and other clinically relevant yeasts and moulds as well as NP432 (Novarifyn®), a peptide antibacterial for difficult to treat multi-drug resistant Gram-negative and Gram-positive infections.

Further information is available at www.novabiotics.co.uk.

About Lynovex®

Lynovex® (NM001) is a unique molecule with a dual antibacterial-mucoactive mode of action which aggressively tackles both of the major clinical features responsible for progressive lung disease in CF. Lynovex® also kills bacteria very rapidly and is active against drug resistant bacteria as well as bacteria that are in biofilm form (the way in which they grow in the CF lung to avoid clearance by the immune system and/or antibiotics) and importantly, reverses antibiotic resistance in bacteria to conventional antibiotics when used alongside these drugs. Lynovex® has orphan drug designation in Europe.

About Cystic Fibrosis

Cystic fibrosis is an inherited, chronic, debilitating, life-limiting disease that affects around 70,000 individuals worldwide. It is caused by a mutation in a single gene, but the effects of this mutation impact and lead to symptoms in multiple internal organs with the lungs and the digestive system typically being the most significant tissues and where treatment is focused. The overproduction of mucus by the cells lining the airways and digestive tract lead to impaired lung function, recurrent or chronic respiratory infections and inflammation or degenerative lung damage and an impaired ability to digest food.

The respiratory infections associated with CF have a deleterious impact on lung function, and the presence of particular bacterial or fungal pathogens can also rule out transplantation as an intervention option for CF patients. NovaBiotics’ CF programme is therefore focused on controlling and eradicating the entire spectrum of bacteria (and fungi) that infect or colonise the lung of CF patients. Doing so is paramount in maintaining and improving lung health, function and quality of life overall for CF patients. Antibiotic resistance to conventional or existing therapies is a major issue in CF because of the length of time and doses to which patients are exposed to these agents over the course of their life. Furthermore, a number of the emerging pathogens that are becoming more commonly associated with CF are inherently insensitive to conventional antibiotic therapies. Lynovex® is a potential solution to these increasing challenges in CF management and is the result of a complete re-think in how best to tackle the infectious component of this chronic, debilitating disease in the long-term.

Issued for and on behalf of NovaBiotics by Instinctif Partners.

For further information please contact:

NovaBiotics:
Dr. Deborah O’Neil - CEO & CSO
deborah@novabiotics.co.uk
Bryan Bodek - Chairman
bryan@novabiotics.co.uk
+44 (0) 1224 711377

For media enquiries:

Instinctif Partners:
Melanie Toyne Sewell
Stefanie Bacher
Gemma Howe
novabiotics@instinctif.com
Tel: +44 (0) 20 7457 2020

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