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NovaBiotics Receives Orphan Drug Status from the US Food and Drug Administration (FDA) for Lynovex® for the Treatment of Cystic Fibrosis

16 September 2014

Orphan drug designation coincides with dosing of first patients in PhIIa study

Aberdeen, UK - 16 September 2014 - NovaBiotics Ltd, the Aberdeen-based clinical-stage biotechnology company ("NovaBiotics" or the "Company"), today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation for Lynovex® (NM001), the Company's first-in-class therapeutic candidate for the treatment of Cystic Fibrosis (CF).

CF is a chronic, life-limiting disease that affects the lungs, digestive tract and other organ systems. It is estimated that there are 30,000 children and adults with CF in the US and upwards of 70,000 people affected worldwide. It is believed that Lynovex® has unique multi-functionality; combined properties of breaking down the excessive mucus produced in the airways of CF patients, killing the bacteria responsible for the recurrent respiratory infections in CF and disrupting/preventing the biofilms which these bacteria typically form in the CF 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® is being developed by NovaBiotics for CF as an oral (tablet) form for acute exacerbations and in inhaled (dry powder) form for chronic use and maintenance. Lynovex® is intended for application alongside existing CF treatments and potentiates their antimicrobial effects. A Phase IIa clinical trial for the oral form of Lynovex® is already underway and the first patients will be dosed this week. PhIIb studies of the oral form of Lynovex in the UK and Europe are expected to commence in 2015. Clinical development of the inhaled form is also anticipated to get underway in H2 of 2015.

Dr Deborah O'Neil, CEO of NovaBiotics, said: "The orphan drug designation for Lynovex® in the US is a major regulatory milestone for NovaBiotics and highlights the unmet need for effective and safe treatments for CF patients. Dosing of the first patients in the Aberdeen Phase IIa clinical trial is also a significant clinical milestone in Lynovex's clinical development."

She added, "If the encouraging data we have achieved so far continues to translate in clinical use, we believe Lynovex® will offer a breakthrough in the treatment of CF. This is a candidate therapy with the potential to significantly improve the health and quality of life for those affected by CF. Importantly, and unlike other treatments that are specific to particular CF mutations, Lynovex® is intended for use by the entire CF patient population, not just sub-groups."

 

Older 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™) 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
Pharmacells stores stem cells for teenager paralysed in car crash | 20 October 2011
NovaBiotics Ltd - Presentation at BIO International 2011, Washington DC | 24 June 2011
Launch of Oristem® | 04 June 2011
GBP in Nexxus newsletter, Spring 2011 | 22 March 2011
Patents granted in key territories as Novexatin® moves closer to further clinical development and commercialisation | 21 February 2011
Unblinded Phase IIa Clinical Trial Data Delivers Excellent Results for Novexatin®, Nova... | 5 July 2010
Successful Completion of Phase IIa clinical trial for Novexatin®, IND filing planned for Phase IIb... | 1 May 2010

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