NP213 (Novexatin)

The first fungal nail therapy to rapidly address the infection and improve nail appearance

Novexatin® is a brush-on-treatment for onychomycosis (fungal nail infection) containing a novel antifungal agent, NP213.  NP213 is a novel, synthetic antimicrobial peptide (AMP) generated from NovaBiotics’ rational drug design technology platform

 

Phase 1 and 2 clinical studies have demonstrated that Novexatin 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).  Novexatin 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.  In clinical studies, patients and physicians reported clinical improvement in affected nails after only 11 days of once-daily Novexatin treatment and >50% of patients‘ nails were clear (by culture test) of fungi 1 year on following 28 days of application of Novexatin (see article and paper here).

 

NP213 rapidly kills fungi causative of nail infections by perturbing and lysing their outer membrane.  This mode of action targets non-metabolising and metabolically active nail fungal pathogens including dermatophyte and non-dermatophyte fungi.  The size, charge, hydrophilicity and cyclic structure of NP213 facilitates the molecules’ rapid penetration through the challenging biological barrier of the nail and to the nail bed, but prevent its absorption through the skin into the systemic environment.  Novexatin provides an effective, nail-hydrating delivery system for its active ingredient NP213, which then remains stable and bioavailable within the nail for more than 12 months post-application.  Antifungal 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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Q&A

1. What is Novexatin?

Novexatin is a clear, colourless, odourless solution which is brushed onto the nail and surrounding skin. It contains a novel antifungal peptide as the active ingredient. This peptide (NP213) is potently active against fungi and is based on the natural antifungal peptides present in the skin and nails which act as the body’s defence against infection.

2. What is Novexatin used for?

Novexatin is a treatment for fungal infection of the toenails and surrounding skin (also known as onychomycosis or tinea unguim). In clinical trials so far, Novexatin was effective against mild to moderate infection, but evidence also suggests it can be effective against more severe infections.

3. When and how will Novexatin be available to patients?

NovaBotics are currently mapping out the most appropriate and expedited route to market for Novexatin.

4. Taro were previously co-developing this drug with NovaBiotics, so whose product is this?

NovaBiotics invented Novexatin and conducted all preclinical and clinical research and development of this product to phase 2a clinical studies.  NovaBiotics own all of the intellectual property and commercial rights to this drug and the previous license with Taro was terminated by mutual agreement in 2018.

5. Why did Taro release a statement that Novexatin failed to meet the trial endpoint in a phase 2b clinical trial?

The phase 2b trial was a study conducted by Taro under the terms of the previous license agreement.  NovaBiotics did not sponsor or manage that study.  The data generated did not accord with data from previous studies and were, unexpectedly, equivocal for a number of reasons. As such the end-point was not met and no firm conclusions could be drawn from the trial’s outcomes.