Latest News

Unblinded Phase IIa Clinical Trial Data Delivers Excellent Results for Novexatin®, NovaBiotics' Lead Product Candidate for the Treatment of Fungal Nail Infection

05 July 2010

NovaBiotics, the clinical-stage biotechnology company, today announces the initial unblinded results from its Phase IIa clinical study for Novexatin®. All study end-points were met in the trial which had been designed to assess the safety and tolerability of the novel antifungal drug candidate.

Novexatin® was confirmed as being safe and well tolerated in all study subjects by the leading global clinical research organisation who conducted the study. These are very positive results in the context of the well described and significant safety/toxicological shortcomings of some currently available treatments.

48 patients with fungal nail infection were dosed daily with Novexatin® for just 28 days, on a single toe nail. Although not an efficacy study, analysis of the clinical improvement of the treated nails, as a measure of Novexatin®’s pharmacodynamic properties (i.e. its ability to penetrate the nail), revealed much better than expected initial evidence of efficacy during both the short 28-day treatment period and the 6-month follow-up assessment window. In this respect Novexatin® has thus far outperformed any other drug candidate developed to treat fungal nail infection and the Company now looks forward to confirming these exciting indicative findings in larger clinical studies specifically designed to assess efficacy in patients. NovaBiotics is currently in the process of filing an investigational new drug (“IND”) application for approvals to undertake these trials in the United States.

The results of the clinical trial strongly suggest that Novexatin® has the potential to revolutionise the market for the treatment of fungal nail infections which affects in excess of 12% of the world’s population. The safety data and pharmacodynamic assessment outcomes achieved for Novexatin® are more compelling than data derived from other products (marketed and in development) tested in larger studies, during which each drug was administered for between three and ten times longer than the Novexatin® 28-day study.

Novexatin® is part of a broad portfolio of products which are being developed by the Company using its unique patented peptide anti-infective technology. The next product in the pipeline is Novamycin®, a candidate treatment for potentially life-threatening blood-stream and deep tissue yeast and mould infections (predominantly Candida) which is expected to enter clinical development in 2011.

Dr Deborah O’Neil, Founder, commented: “Now the study has completed in patients and we can interpret the significant data set acquired over the past 6 months, the positive results take the next key steps to confirming what we have always known from the laboratory; Novexatin®’s ability to safely remedy a very common and hard to treat condition. This safe and novel treatment is designed to be closely related to the body’s natural antifungals and addresses the various and well described shortfalls of the limited number of existing therapies that currently serve a global fungal nail infection market potentially worth $5 bn.”

“The data collected now points a very clear path to a phase IIb study which will take us closer to bringing this product to market.”

 

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