Washington DC, 27-30 June -- NovaBiotics Chief Scientific Officer and Founder of the leading clinical-stage biotechnology company, Dr Deborah O’Neil, will be presenting at the biotechnology industry’s largest event, the BIO International Convention in Washington, 27-30 June, giving an update on the technology and recent developments as well as outlining the Company’s future plans.
Dr O’Neil will be presenting on Thursday, June 30 at 9.30am in the Capitol Hill suite.
The company is preparing to carry out a multi-centre phase IIb clinical study (“the study”) for its’ lead asset Novexatin® in 2011/2012 in the USA.
Partnering discussions are ongoing in parallel with potential licensing partners.
Novexatin®, the company’s lead product, is a topical treatment for fungal nail infection and addresses a poorly served $3 billion global market. Novexatin® is a unique product, with clinical data derived thus far confirming that it addresses the profound safety and efficacy shortcomings of existing remedies for fungal nail infection. NovaBiotics’ data suggest a step change in patient care is possible with superior cure rates predicted by the IIb study following a month’s treatment rather than the 12 months required for current topical therapies.
Dr Deborah O’Neil and Professor Andy Porter will attend the event as part of the Scottish delegation. Dr Deborah O’Neil commented, “I am delighted that NovaBiotics has been selected to present at this year’s BIO International in Washington and that we’ll be able showcase our technology to a worldwide audience. This comes on top of an already packed partnering schedule through which we’re looking forward to sharing recent exciting advances with Novexatin®, Lynovex™, Novamycin® and Novarifyn™ with existing and also new potential partners.
“Our discussions with the US Food and Drug Administration (FDA) are on track towards gaining investigational new drug (IND) approval for Novexatin® to facilitate a large, multi-centre phase IIb efficacy study, which will be a major milestone in this potentially world-beating technology’s commercialisation journey.”
Professor Andy Porter adds, “I am thrilled with the continued success of Novexatin but also have high hopes for our pipeline products which include LynovexTM our dual muco-active anti-bacterial already showing exciting activity when compared with similar molecules, and Luminaderm® our OTC platform from which compounds are currently being assessed by some of the world’s largest consumer health players.”
For further information please contact:
Dr Deborah O’Neil 01224 711377
Diane Stewart, Carrie Clement
0131 226 6150 / 0207 466 5000
NovaBiotics is a clinical-stage biotechnology company which was founded in 2004 and focuses on the design and development of novel peptide antifungal and antibacterial therapeutics. Through a streamlined informed drug design approach, the Company has successfully delivered a phase IIb-ready lead clinical asset, Novexatin® in a very short space of time. The initial unblinded results from the Phase IIa study were excellent. 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.
Furthermore, the Company’s second product, Novamycin® is anticipated to reach a phase I clinical study for a global $5.7 bn systemic antifungals market by mid-2012.
In February this year NovaBiotics announced it had further secured the global intellectual property (‘IP’) position of its lead product, Novexatin® through recent patent grants in the US, EU and other territories worldwide. The Company’s granted and pending IP not only protects the use of the core structure of Novexatin®, but of a related family of anti-infective peptides derived from the same technology platform. This is a critical milestone for the Company with key grants for its lead and follow-on products being secured at a relatively early stage in their lifecycle.
The Company has an attractive mix of a clinical product, unique platform technology and a robust product pipeline which the directors believe have the ability to treat a range of poorly served and economically significant infections. NovaBiotics’ current anti-infectives product portfolio also includes:
- Novamycin®, a candidate treatment for potentially life-threatening blood-stream and deep tissue yeast and mould infections (predominantly Candida) as well as debilitating infections of the buccal cavity (Oropharangeal Candidiasis).
- Novel dual mucoactive-antibacterial drug candidate, Lynovex™ / MufroSyn™ now completing its proof of efficacy stage for the treatment of respiratory infections including multi-drug resistant forms and those associated with cystic fibrosis.
- Novarifyn™, a lead antibacterial peptide with activity against community acquired bacterial systemic infections including MRSA, as well as acne and polymicrobial dermal infections associated with ulcers, burns and wounds. There is also an initial focus on cystic fibrosis.
- Luminaderm® partner-ready product portfolio, polymer & botanical antifungals & antibacterials, which have a broad range of cosmetic healthcare applications for skin, hair, eyes, teeth and nails and are due to enter consumer studies in early 2012.
Further information can be found on the website www.novabiotics.co.uk