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NovaBiotics Ltd Initiates Development Of Orphan Drug In Cystic Fibrosis


12/17/2013 9:41:21 AM

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Aberdeen, UK – 17 December 2013 – NovaBiotics Ltd, the Aberdeen-based clinical-stage biotechnology company (“NovaBiotics” or the “Company”), today announced it has initiated the development of an inhaled form of Lynovex, its treatment for cystic fibrosis (CF).

Lynovex is an orphan drug candidate that breaks down mucus, disrupts and prevents bacterial films and acts as an antibacterial against Gram-negative and Gram-positive respiratory bacteria.

NovaBiotics is working with inhalation formulation specialists at Crystec in Bradford, UK to develop dry powder inhalable forms of the drug. The aim of administering the drug by aerosolisation is to deliver maximum efficiency with lower doses of the treatment targeted directly to the relevant areas of the respiratory tract.

As a maintenance therapy, the inhaled form of Lynovex is intended for the long term control of the chronic lung infections and mucus production associated with CF. In addition, NovaBiotics is investigating a tablet form for Lynovex for use in acute exacerbations of CF and is working with NHS Grampian and the University of Aberdeen’s CF research team to undertake a phase IIa clinical trial of this new formulation, commencing in early 2014.

Dr Deborah O’Neil, CEO of NovaBiotics, said: “Current treatments for cystic fibrosis are limited and by no means wholly efficacious. Multiple therapies are often required but Lynovex could offer the possibility of a multifunctional, single treatment which addresses mucus production, bacterial infections and also persistent bacterial biofilms and I’m excited at the prospect of investigating how an inhaled form can achieve these clinical aims and, in doing so, could improve lung function in CF patients in the long term.”

Peter York, Chief Scientist at Crystec, said: “We are delighted to be supporting NovaBiotics on this project. We believe that bringing together the therapeutic potential of Lynovex with the ‘best in class’ lung delivery performance of Crystec’s engineered particles could represent a ground-breaking treatment for this debilitating disease.”

As Lynovex progresses through clinical trials, NovaBiotics is enhancing its intellectual property and trademark portfolio for this and its other technologies and product candidates. NovaBiotics recently received a US grant for the Lynovex trademark.

NovaBiotics’ collaboration with the Cystic Fibrosis Trust to fund the upcoming phase IIa study will be highlighted as a case study at the UK Bioindustry Association’s Annual Parliament Day on 30 January 2014, a flagship advocacy event which represents the sector’s top policy needs to senior policymakers across government and sets the agenda for the year ahead.

About NovaBiotics

NovaBiotics is developing novel peptide antifungal and antibacterial therapeutics that have the ability to treat a range of poorly served and clinically challenging infections. The mechanism of action of NovaBiotics’ drug candidates minimises or negates the chance of drug resistance developing in the target microbes/infections which they have been designed to treat. NovaBiotics’ antifungal and antibacterials are not toxic to human cells at therapeutic doses unlike many conventional antimicrobial medications. NovaBiotics’ lead clinical programme is Novexatin®. In addition to Novexatin®, the Company is developing Lynovex®, for cystic fibrosis (CF) an antibacterial compound that also breaks down excess mucus produced in the airways of CF patients that is expected to enter a Phase IIa study in Q1 2014; Novamycin®, a peptide antifungal agent against Candida and Aspergillus; Novarifyn®, a peptide antibacterial for difficult to treat multi-drug resistant Gram-negative and Gram-positive infections, including MRSA. Further information is available at www.novabiotics.co.uk.

About Lynovex®

Lynovex has a unique, dual mucoactive-antibacterial mode of action which aggressively tackles both of the major clinical features responsible for progressive lung disease in cystic fibrosis (CF). CF is a fatal respiratory disease for which a complete re-think is clearly required as regards the much-needed solution for a more effective, safe, long-term therapy to improve lung function in those patients affected.

About Cystic Fibrosis

Cystic fibrosis is a life-shortening inherited disease, affecting over 10,000 people in the UK and 70,000 Worldwide. Ninety percent of patients are diagnosed before the age of 17 and it is the number one genetic killer of children and young adults. Finding a treatment that can tackle the common infections and resistance that affect and shorten lives is a priority for patients and their families.

Issued for and on behalf of Novabiotics by College Hill.

For more 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

College Hill:

Melanie Toyne Sewell/Stefanie Bacher/Gemma Howe

novabiotics@collegehill.com

Tel: +44 (0) 20 7457 2020

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