NP213/Novexatin™

Nail fungus is not merely a cosmetic condition and impacts the quality of life of those affected, causing a great deal of pain, discomfort and embarrassment. Current treatment options, in either tablet (oral) or lacquer (topical) form can be lengthy in duration, costly and are generally poor in efficacy. Relapse of the infection following treatment for nail fungus is all too common. Oral therapies for nail fungus are associated with a range of serious side effects and toxicity, the most significant being fatal liver and congestive heart failure.

Because of the shortcomings of currently available treatment options, less than 50% of those affected with nail fungus take or use any of the available remedies to treat the condition. Of note, target pathogens are already demonstrating resistance to these therapies.

NP213/Novexatin^® is fungicidal (i.e. kills rather than inhibiting the growth of the fungus) against the causative agents of nail fungus (predominantly Trichophyton spp) and acts through membrane disruption. This mode of action provides significantly greater chances of long-term therapeutic benefit without relapse and minimises, if not negates, the risk of acquired resistance developing in target pathogen populations. NP213/Novexatin^® is also effective against other pathogens that co-infect the nail and surrounding skin along with Trichophyton.

Compared to currently available therapies, NP213/Novexatin^® is unique in its ability to penetrate and remain bioavailable within the nail. As such, NP213/Novexatin^® can clear fungal infection from full thickness toe nails very rapidly (see technical summary). NovaBiotics' unique ex vivo nail model has demonstrated clearance of infection within 28 days.

For more information see the Novexatin^® FAQs page

NovaBiotics’ lead therapeutic candidate is NP213/Novexatin^®, a topical (brush-on) treatment for fungal nail infection (onychomycosis/tinea unguium). This is an economically important disease of the toe and finger nails and surrounding skin and affects as many as 12% of the global population. Very few treatment options are available for this all too common condition and in general will work, at best, in only 40% of patients who use them and require between 12 and 42 weeks of application for any noticeable improvement. Relapse of fungal nail infection occurs frequently and overall, the massive unmet clinical need for a better and safer treatment for this indication translates to a potential market worth in the order of $5 bn.

NP213/Novexatin® has successfully completed phase I of clinical evaluation in which safety and tolerability were confirmed in 12 fungal nail infection patients. Importantly, no NP213/Novexatin® was detected in the bloodstream of any of the patients dosed during the course of the study. A phase IIa clinical study successfully completed with initial data generated in 2009. Patients are being followed-up for 180 days after initiation of treatment and final, unblended data will be available in summer 2010. NovaBiotics aims to partner with/out-license Novexatin® to an appropriate pharmaceutical entity for further clinical development of what the company believes is a world-beating, first-in-class therapeutic candidate and positive discussions with a number of parties are ongoing.