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.”
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