Novexatin NP213

Novexatin® (NP213) is a novel cationic antifungal peptide that has been formulated as a brush-on-treatment for onychomycosis (fungal nail infection).

Phase I and IIa clinical studies have demonstrated that NP213 is safe, well-tolerated and effective in resolving toenail infections following just one month of daily application (currently available topical treatments require up to 52 weeks of treatment). NP213 is the first fungal nail infection therapy to address both the underlying cause of the condition and the cosmetic issues associated with the infection; by rapidly killing the causative fungi and rapidly improving the nail’s appearance.

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 Current Trial Site.

Molecule Class

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 observedin 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.