Novobiotics - Positive Initial Phase IIa Data

LONDON, Nov. 2, 2009--Biotechnology company NovaBiotics, which focuses on the design and development of novel peptide antifungal and antibacterial therapeutics, confirms that the first patients enrolled in its Novexatin® Phase IIa clinical trial have successfully completed a 28 day daily application of the novel antifungal compound.


Novexatin® (NP213), a topical (brush-on) treatment for fungal nail infection, is NovaBiotics’ lead product and is currently being tested in 48 patients. The results obtained so far from the current study confirm the positive data gathered from the Phase I trial carried out earlier this year.


Novexatin® has proven to be well tolerated, has not been detected in plasma and no adverse reactions have been reported in any of the 48 patients enrolled during the month-long exposure phase of the current phase IIa trial. Microbiological analysis of the patient’s nails is also successfully underway in order to confirm the ability of Novexatin® to penetrate the patient’s nail and clear infection therein. The remaining patients will complete the study shortly and the company expects to announce the data later this year.


As previously stated, the Directors plan to out-license or co-develop Novexatin® to/with an appropriate pharmaceutical or specialty pharma partner for further clinical development. We are pleased to report that those discussions are progressing well. NovaBiotics is also at an advanced stage in the appointment of a financial advisor to advise on the valuation of Novexatin® and NovaBiotics’ other technology assets to support these negotiations.


Dr Deborah O’Neil will be presenting the clinical data obtained thus far at Europe’s largest biotechnology partnering conference, Bio-Europe, in Vienna on 3 November 2009. Dr O’Neil and Professor Andy Porter, non-executive director, are participating in the one-to-one partnering sessions at Bio-Europe and are attending the meeting as part of the delegation led by Scottish Development International.


Dr Deborah O’Neil, Founder, commented: “I am pleased to report that Novexatin® appears to be working as we expected it to, with no safety issues. Clearly, we won’t know absolutely until the full trial is completed but the early indications are that have a treatment which has none of the side effects of existing products.”

Ends
For further information please contact:
For further information please call:

NovaBiotics Ltd
Dr Deborah O’Neil 01224 711377

Buchanan Communications
Diane Stewart / Tim Anderson
0131 226 6150 / 0207 466 5000

Notes to Editors
NovaBiotics is a clinical-stage biotechnology company which was founded in 2004 and focuses on the design and development of antifungal and antibacterial therapeutics. NovaBiotics offers 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 including.

• Fungal nail infection
• Life-threatening blood stream and deep tissue yeast and mould infections (e.g Candida)
• Respiratory Psuedomonal infections and those associated with Cystic Fibrosis
• Antibiotic resistant and susceptible dermal, blood stream and tissue Staphylococcal infections
• Acne and polymicrobial dermal infections

The company has a strong lead product in its first application for the topical treatment of nail fungus (“NP213/NovexatinTM”).
Competitive Landscape
Nail fungus affects in excess of 12% of the world’s population and equates to a total global market worth in the order of $5 bn.
The efficacy and safety shortcomings of current therapies are such that patient usage is restricted. In general, they involve lengthy application regimes, are costly and associated with a high degree of relapse. Available systemic treatments are also associated with potentially very serious side effects and toxicity.

Novexatin® has an established preclinical safety and toxicological profile and can be delivered to the nail in such a way as to improve appearance and hydration of the nail. Novexatin® penetrates full-thickness nail, remaining active in the nail bed, without being absorbed into the skin. All of these factors are unique to Novexatin® which has also been designed with cost-effective manufacture and flexibility of formulation in mind.
 

Posted: November 2009

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