NovaBiotics Ltd's Novexatin(R) IND Filing Planned For Phase IIb Study And Completion Of Fundraising

Published: Apr 30, 2010

Biotechnology company NovaBiotics, confirms that following the successful completion of its Phase IIa clinical trial for its lead product Novexatin®, a brush on treatment for fungal nail infection, it is now preparing for further clinical evaluation and plans to file an investigational new drug application (IND) with the US Food and Drug Administration (FDA) for a US-based Phase IIb study.

This announcement follows analysis of the final microbiological data set from NovaBiotics’ 48 patient Phase IIa clinical study in which subjects were dosed daily with Novexatin® for 28 days. The study met its end-points of demonstrating safety and tolerability of the test item and pharmacodynamic analysis indicates that the majority of patients remain infection free 6 months after a 28 day treatment course.

Dr Deborah O’Neil, Founder and Chief Scientific Officer of NovaBiotics will be presenting this latest data at the biotechnology industry’s largest event, the BIO International Convention in Chicago, 3 - 6 May.

The Company also announces today that it has secured an indicative £1.6m from existing shareholders and is on track to reach its H1 financing target of £2.5 m to fund further development of Novexatin® and its product pipeline.

Dr Deborah O’Neil, Founder, commented: “The phase IIa data we have generated for Novexatin® provides a clear route forward for further development and an IND filing to facilitate a phase IIb study will be a major milestone for what we believe is world beating technology. Completion of the fundraising is key to enabling us to do that and I would like to take this opportunity to thank our supportive shareholders. I am also delighted that NovaBiotics has been selected to present at this year’s BIO and we already have an extensive schedule of partnering meetings and a full programme."

The fungal nail infection market is estimated to be worth $5bn globally. Novexatin® is part of a wider portfolio of products which are being developed from NovaBiotics’ platform technology. The Company’s second drug candidate is Novamycin®, a fast-acting antifungal peptide to treat potentially life-threatening systemic yeast and mould infections. At BIO, Dr. O’Neil will be discussing exciting new developments on Novamycin’s safety and efficacy in vivo. NovaBiotics’ pipeline also comprises antimicrobial peptides and compounds for respiratory, system and dermal infections.

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

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.

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