Clinical and Commercial Development
In August 2013, NovaBiotics entered in an exclusive global licensing agreement with Taro Pharmaceuticals for the continued clinical development, manufacturing and marketing worldwide of Novexatin. Novexatin is currently in a large, multi-centre Phase IIb study for mild-to-moderate onychomycosis in the US.
Novexatin is a novel, potent, synthetic antimicrobial peptide (AMP) generated from NovaBiotics’ rational drug design technology platform. Specifically, NP213 is a cyclic arginine-based heptamer and the fungicidal Active Pharmaceutical Ingredient (API) of Novexatin.
Mechanism of Action
Novexatin is rapidly fiungicidal through a membranolytic mode of action that targets both non-metabolising and metabolically active nail fungal pathogens. This includes both dermatophyte and non-dermatophyte fungi associated with onychomycosis. The size, charge, hydrophilicity and cyclic structure of Novexatin facilitate the molecules’ rapid penetration through the challenging biological barrier of the nail and into the nail bed, but prevent its absorption through the skin into the systemic environment. Novexatin remains stable and bioavailable within the nail for more than 12 months post-application. Resistance has not been observed in vitro and Novexatin is not subject to the safety and toxicological issues associated with the use of competitor products, particularly orally administered systemic antifungal agents.
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Onychomycosis affects an estimated 12% of the world’s population. There are a number of environmental and medical risk factors associated with this condition including physical insult to the nail, poor circulation, compromised immunity and diabetes; onychomycosis being a major comorbidity - along with foot ulcers – for type II diabetes. Fungal nail infection has a higher prevalence in the elderly which, against a background of an ageing population means that the overall frequency of fungal nail infections will increase over time. By 2022, the global market for this disease is forecast as being greater than $6 billion. Importantly onychomycosis is not merely a cosmetic condition; it also impacts the quality of life of those affected. Current treatments are either ineffective or associated with adverse effects and the market is poised for rapid uptake of a novel treatment with the unique and highly differentiated features of Novexatin