Bolstered by an EU orphan drug designation for its drug candidate for cystic fibrosis, Lynovex (cysteamine), UK-based NovaBiotics revealed to Scrip that it plans to begin a first-in-man, safety/tolerability and evidence of efficacy study of the product in 2012, followed by other trials in 2013.
The company announced that the Committee on Orphan Medicinal Products (CHMP) of the European Medicines Agency (EMA) has granted orphan status to the novel dual mucolytic-antibacterial drug for the treatment of cystic fibrosis and added that it is "currently in discussions with a number of interested parties with a view to licensing or co-developing the drug".
NovaBiotics stated it would "now progress with follow-on orphan applications for paediatric use and also applications for orphan drug designation in the US".
"This novel drug candidate is expected to be tested in patients in 2012," the biotech firm highlighted. It told Scrip that the study slated for next year would test Lynovex when used in conjunction with conventional inhaled ABX (antibiotic) therapies in the first instance. In 2013, NovaBiotics said it would initiate a second and third trial to further assess efficacy.
The company confirmed that it intends to partner the product, and "as per our core business model [this is] most likely after the second clinical study". With respect to its finances, it said: "NovaBiotics remains fully equity funded (still pre-revenue) and this is how development has been/will be funded in the short-term for Lynovex, but as the programme develops towards final clinical studies, revenue from Novexatin and Luminaderm commercialisation deals will be reinvested into the Lynovex programme."
Last year, NovaBiotics released positive un-blinded Phase IIa data for its lead product candidate Novexatin (NP-213), a treatment for fungal nail infection and at the time said it was in ongoing partnering discussions for the medication ( scripintelligence.com, 5 July 2010).
In an update the company said that partnering discussions were still active or ongoing according to region (with talks going on in the US, Japan and South America among others). It noted that NovaBiotics is also open to global deals for Novexatin.
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
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