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Unblinded Phase IIa Clinical Trial Data Delivers Excellent Results for Novexatin(R), NovaBiotics Ltd Lead Product Candidate for the Treatment of Fungal Nail Infection


6/30/2010 11:09:53 AM

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.”

For further information please contact:

NovaBiotics Ltd Dr Deborah O’Neil 01224 711377

Buchanan Communications Diane Stewart 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. 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 H1, 2011.

In addition to developing an antimicrobial peptide platform technology with further antifungal potential, NovaBiotics’ antibacterial peptide drug candidates are now at the lead compound selection stage for both Gram-negative (Pseudomonas aeruginosa respiratory infections including multi-drug resistant forms) and Gram-positive (Staphylococcus aureus deep tissue and skin infections including MRSA) bacterial indications.

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 including:

• Fungal nail infection;

• Life-threatening blood stream and deep tissue yeast and mould infections (e.g Candida spp, Aspergillus spp, Cryptococus);

• Respiratory Pseudomonal infections and those associated with Cystic Fibrosis;

• Antibiotic resistant and susceptible dermal, blood stream and deep tissue Staphylococcal infections;

• Acne and polymicrobial dermal infections associated with ulcers, burns and wounds; and

• Consumer health focused indications including seborrhoeic dermatitis (dandruff), adult acne and foot care.

Competitive Landscape - Novexatin®

The efficacy and safety shortcomings of current therapies (only four have been approved to date) for fungal nail infection are such that patient usage is restricted. In general, they involve lengthy application regimes (up to 300 days), 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 and clinical 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 therein, without being absorbed into the skin and exposed to the systemic environment. All of these factors are unique to Novexatin® which has also been designed with cost-effective manufacture and flexibility of formulation in mind.



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