Successful Phase IIa Clinical Development of its Nail Fungus Treatment, Novexatin® Biotechnology company NovaBiotics, confirms that is has successfully completed the dosing phase and initial analyses of its Phase IIa clinical trial for its lead product Novexatin®, a brush on treatment for fungal nail infection and is now in active discussions to outlicense the clinical development of this product.
In the Phase IIa study, 48 patients have been dosed daily on one infected toe nail with Novexatin® over a 28 day period. The results of the study thus far have been very encouraging with the end points of safety and tolerability having been achieved. Moreover, the pharmacodynamic assessment to determine the extent to which the drug candidate could penetrate the nail revealed that samples from the majority of patients had no viable dermatophyte fungi present after a month’s exposure to Novexatin® or placebo control.
The study remains blinded until all follow-ups are complete, but 1/3 of the patients are on placebo control and 2/3 on active drug candidate. This rate of indicative mycological cure after only 1 month of treatment is higher than has been reported for existing remedies but importantly there is no evidence of any of the potentially serious side effects reported for those treatments, most notably liver damage.
Novexatin® is part of a wider portfolio of products which are being developed. The next product in the pipeline will be Novamycin, a candidate treatment for potentially life-threatening blood-stream and deep tissue yeast and mould infections (predominantly Candida) which should enter clinical development in 2010.
Dr Deborah O’Neil, Founder, commented: “This study confirmed what we anticipated. Novexatin® is a unique product that can address the global market of fungal nail infection, which is poorly served at the moment. As such, Novexatin® has the potential to access a significant proportion of a global market worth $5 Bn.
We are now actively in discussions with potential partners to further the clinical development of this product and the availability of this very encouraging data should now enable us to achieve our aim of taking this product to market.” For further information please contact: For further information please call:
NovaBiotics Ltd
Dr Deborah O’Neil 01224 711377
Buchanan Communications
Diane Stewart / Tim Anderson / Carrie Clement
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 novel peptide antifungal and antibacterial therapeutics. The Company 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 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.
