NovaBiotics Ltd - a spinout of the University of Aberdeen Rowett Institute of Nutrition and Health – has successfully completed phase one of trials for a brush-on treatment for fungal nail infection.
Initial data from the first of its two part clinical trials for its lead product, Novexatin® (NP213), has been encouraging.
This first component of the Berlin-based clinical trial assessed the safety, tolerability and pharmacokinetics of a single dose of Novexatin® and also the placebo, in 12 patients.
Importantly, Novexatin® could not be detected in plasma from any patients up to 16 hours after exposure to the drug and no adverse reactions were reported, in either the placebo and Novexatin® treatment group.
A larger Phase IIa trial will now commence in which 48 patients will be dosed daily with Novexatin® over a 28 day period. Recruitment of patients for this trial is almost complete.
Novexatin® has been proven so far to rapidly clear fungal nail infection in NovaBiotics’ nail infection models.
Nail fungus affects in excess of 12% of the world’s population and equates to a total global market worth in the order of $5 bn.
As clinical data becomes available, the Directors plan to out-license Novexatin® to an appropriate pharmaceutical or speciality pharma partner to undertake further clinical development. Discussions are currently ongoing with a number of potential partners.
Dr Deborah O’Neil, Founder, said: “This initial data provides the platform we expected in order for us to move on to assess the safety and pharmacodynamics of Novexatin in the anticipated 28 day daily dosing cycle. It is an important safety milestone and we’re very encouraged.”