Novabiotics, the Scottish biotechnology company which is focused on the design and development of antifungal and antibacterial therapies, yesterday said it had successfully completed phase one of its two-part human clinical trials for its product, Novexatin, a brush-on treatment for fungal nail infection.
The Aberdeen-based company said the initial clinical data from the trial was very encouraging, and gives the green light to the trail phase.
This first component of the Berlin-based first-in-man 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, the company said.
A larger phase two trial will begin 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' models.
Nail fungus is estimated to affect around 12% of the world's population and equates to a total global market worth of around $5bn.
Dr Deborah O'Neil, the company's 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."
