Latest News

Successful Completion of Phase IIa clinical trial for Novexatin®, IND filing planned for Phase IIb study and successful £1.6m rights issue

01 May 2010

Biotechnology company NovaBiotics, confirms that following the successful completion of its Phase IIa clinical trial for its lead product Novexatin®, a brush on treatment for fungal nail infection, it is now preparing for further clinical evaluation and plans to file an investigational new drug application (IND) with the US Food and Drug Administration (FDA) for a US-based Phase IIb study.

This announcement follows analysis of the final microbiological data set from NovaBiotics' 48 patient Phase IIa clinical study in which subjects were dosed daily with Novexatin® for 28 days. The study met its end-points of demonstrating safety and tolerability of the test item and pharmacodynamic analysis indicates that the majority of patients remain infection free 6 months after a 28 day treatment course.

The Company also announces today that it has secured an indicative £1.6m from existing shareholders and is on track to reach its H1 financing target of £2.5 m to fund further development of Novexatin® and its product pipeline.

Dr Deborah O'Neil, Founder, commented: "The phase IIa data we have generated for Novexatin® provides a clear route forward for further development and an IND filing to facilitate a phase IIb study will be a major milestone for what we believe is world beating technology. Completion of the fundraising is key to enabling us to do that and I would like to take this opportunity to thank our supportive shareholders. I am also delighted that NovaBiotics has been selected to present at this year's BIO and we already have an extensive schedule of partnering meetings and a full programme."

The fungal nail infection market is estimated to be worth $5bn globally. Novexatin® is part of a wider portfolio of products which are being developed from NovaBiotics' platform technology. The Company's second drug candidate is Novamycin®, a fast-acting antifungal peptide to treat potentially life-threatening systemic yeast and mould infections. At BIO, Dr. O'Neil will be discussing exciting new developments on Novamycin's safety and efficacy in vivo. NovaBiotics' pipeline also comprises antimicrobial peptides and compounds for respiratory, system and dermal infections.

 

Older News

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' Dr Deborah O'Neil Wins Entrepreneur of the Year
27th June 2014

NovaBiotics Initiates Phase IIa Clinical Study for Lynovex in Cystic Fibrosis
25th June 2014

NovaBiotics' Dr Deborah O'Neil Named EY Scotland Entrepreneur of 2014
20th June 2014

NovaBiotics Initiates Development of Orphan Drug in Cystic Fibrosis
17th December 2013

Pharmacells to expand following funding boost
24 September 2013

NovaBiotics Enters into Agreement with Taro
28 August 2012

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