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Phase IIa clinical study results for NovaBiotics' Lynovex® presented at the 38th Annual European Cystic Fibrosis Symposium

12 June 2015

Clinical data supports the application of Lynovex® as a novel treatment for the infectious exacerbations associated with cystic fibrosis

Aberdeen, UK - NovaBiotics Ltd, the Aberdeen-based specialty biotechnology company ("NovaBiotics" or the "Company"), today announces the presentation of data from a Phase II a clinical trial of its orphan candidate cystic fibrosis (CF) treatment, Lynovex® (NM001) at ECFS.

Lynovex® (NM001) is being developed by NovaBiotics in oral (capsule) form as the first therapeutic intervention specifically intended to address the infectious exacerbations associated with CF. In parallel, NovaBiotics are developing an inhaled form of Lynovex® for chronic use in CF. In both oral and inhaled form, Lynovex® is intended as an adjunct to standard of care antibiotic therapy.

The data presented at this years' ECFS are from a 10 patient Phase IIa clinical study conducted by Aberdeen University's Professor Graham Devereux and his clinical team at Aberdeen Royal Infirmary. In this study, stable adult CF patients from the Aberdeen CF centre cohort received a range of (increasing) Lynovex® doses over the course of 5 weeks alongside their standard of care therapy regimens. The primary objectives of the study were to assess whether the active component of Lynovex® (cysteamine) was safe and well tolerated by the patients, whether it was absorbed into the bloodstream and from there, reached the lung tissue. The study also monitored any initial evidence of clinical benefit from Lynovex®.

The optimal dose at which the drug was safe and well tolerated and absorbed into the blood stream was determined from the trial, as was confirmation that Lynovex® entered the bronchial secretions of the CF patients. Furthermore, the data generated by Professor Devereux suggests that Lynovex® had positive impacts on a number of clinical parameters measured (sputum bacterial load, sputum viscosity, etc.).

The acute, infectious exacerbations that CF patients can suffer multiple times each year have an irreversible, deleterious impact on lung function and quality of life for CF patients. There is a clear, unmet medical and market need for treatments that are designed specifically to not only target the causative bacteria, but also to alleviate the symptoms which patients suffer during these episodes. In laboratory tests Lynovex® (NM001) has already demonstrated unique multiple properties ideally suited to minimising the impact of exacerbation events. The clinical data generated by the study conducted by Professor Devereux appear to confirm these early findings and go further to support Lynovex's utility as a CF therapeutic in acute exacerbations. The next/final phase of clinical development of this first-in-class CF exacerbation therapy is anticipated to commence within the next 12 months.

Professor Devereux said: "These results are very promising. We were pleasantly surprised because some of the patients improved considerably. The CF team and the CF patients in Aberdeen are very keen to contribute to the development of Lynovex®. The experiences gained by actually giving the drug to people with CF will prove invaluable in the development of Lynovex®".

Dr Deborah O'Neil, CEO of NovaBiotics, said: "This encouraging data is a key step in the development of Lynovex® as a much needed therapy in CF exacerbations. At the optimal dose, the drug was not only well tolerated and absorbed by the patients, but reached the lungs in the concentration ranges at which we know this molecules' potent mucolytic and antibacterial effects can be elicited." She adds, "This trial was only the first study of Lynovex® in adult CF patients, but a very carefully designed one by Prof Devereux that generated meaningful, and in some cases striking findings on which we are already building the final clinical trials required for Lynovex® to be marketed for CF in Europe, the US and elsewhere. From my perspective, this data goes further to support the potential breakthrough that Lynovex® may offer in CF".

 

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NovaBiotics secures an additional £3.0 million investment from Woodford Investment Management | 3rd March 2017
Commercial Collaboration Deal for (Oral) Lynovex® | 5th August 2016
NovaBiotics Announces New Data on Cysteamine (Nylexa™) as an Antimicrobial Resistance Breaker in Multi Drug Resistant Bacteria | 18 June 2016
NovaBiotics Highlights Importance of Co-ordinated Approach to Antimicrobial Resistance | 7th June 2016
NovaBiotics Wins Investment of the Year Award | 5 Feb 2016
Lynovex® Activity in CF sputum & Against the Emerging CF Pathogen, Mycobacterium abscessus | 12 Aug 2015
Phase IIa clinical study results for NovaBiotics' Lynovex® presented at the 38th Annual European Cystic Fibrosis Symposium | 12 Jun 2015
Launch of the BEAM Alliance | 9 Jun 2015
NovaBiotics Quoted in "What Investment" on 11 February | 11 Feb 2015
NovaBiotics Raises £5.0 million in a Private Placement from Woodford Investment Management | 19 Jan 2015
NovaBiotics' Dr Deborah O'Neil Named EY UK Health Products & Services Entrepreneur of 2014 | 7 Oct 2014
Showcases increasing investor interest in the global stem cell sector | 22 Sep 2014
NovaBiotics Receives Orphan Drug Status from the US Food and Drug Administration (FDA) for Lynovex® | 16 Sep 2014
Scotland's Pharmacells Group creates 12 new jobs at BioCity Scotland following acquisition by Precious Cells Group, London | 18 August 2014
Precious Cells Biobank Acquires Stem Cell Technology Leader Pharmacells Group | 25 July 2014
NovaBiotics' Dr Deborah O'Neil Wins Entrepreneur of the Year | 27 June 2014
NovaBiotics Initiates Phase IIa Clinical Study for Lynovex in Cystic Fibrosis | 25 June 2014
NovaBiotics' Dr Deborah O'Neil Named EY Scotland Entrepreneur of 2014 | 20 June 2014
NovaBiotics Initiates Development of Orphan Drug in Cystic Fibrosis | 17 December 2013
Pharmacells to expand following funding boost | 24 September 2013
NovaBiotics Enters into Agreement with Taro | 28 August 2013
First patient dosed at Aberdeen Royal Infirmary in major international study | 29 August 2012
Pharmacells in talks to extend reach overseas | 24 January 2012
New hope in cystic fibrosis fight as Scots patients first to test drug | 2 January 2012
NovaBiotics reveals plans for cystic fibrosis drug after EU grants orphan status | 19 December 2011
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NovaBiotics Ltd - Presentation at BIO International 2011, Washington DC | 24 June 2011
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Latest News

NovaBiotics secures an additional £3.0 million investment from Woodford Investment Management
3rd March 2017

Commercial Collaboration Deal for (Oral) Lynovex®
5th August 2016

NovaBiotics Announces New Data on Cysteamine (Nylexa™)
18th June 2016

NovaBiotics Highlights Importance of Co-ordinated Approach to Antimicrobial Resistance
7th June 2016

NovaBiotics Wins Investment of the Year Award
5th February 2016

Lynovex® Activity in CF sputum & Against the Emerging CF Pathogen, Mycobacterium abscessus
12th August 2015

Phase IIa clinical study results for NovaBiotics' Lynovex® presented at the 38th Annual European Cystic Fibrosis Symposium
12th June 2015

Launch of the BEAM Alliance
9th June 2015

NovaBiotics Quoted in "What Investment" on 11 February
11th February 2015

NovaBiotics Raises £5.0 million in a Private Placement from Woodford Investment Management
19th January 2015

NovaBiotics' Dr Deborah O'Neil Named EY UK Health Products & Services Entrepreneur of 2014
7th October 2014

Showcases increasing investor interest in the global stem cell sector
22nd September 2014

NovaBiotics Receives Orphan Drug Status from the US Food and Drug Administration (FDA) for Lynovex®
16th September 2014

Scotland's Pharmacells Group creates 12 new jobs at BioCity Scotland following acquisition by Precious Cells Group, London
18th August 2014

Precious Cells Biobank Acquires Stem Cell Technology Leader Pharmacells Group
25th July 2014