Drug company Blueberry Therapeutics reported on Tuesday the receipt of the investigational new drug (IND) clearance from the Food and Drug Administration (FDA) to initiate the clinical development of BB2603 for the treatment of onychomycosis (fungal toenail).

The company added that BB2603 is a nanoformulated, topical form of terbinafine for the treatment of onychomycosis. It aims to maintain the efficacy of the oral gold standard treatment, but at a lower dose. Delivering the active pharmaceutical ingredient using nanotechnology ensures it penetrates across the nail plate and reaches the target site of action in a controlled manner in lower doses.

Under the company's Phase IIb international, multicentre double-blinded study, the primary outcome is to look at the efficacy BB2603 in onychomycosis, with a secondary dose finding outcome also being investigated.

According to CEO John Ridden, the company will work with over 20 international sites on the Phase IIb trial of BB2603 with the first patient expected to be recruited in March 2020.This is a key milestone to commercialisation of its nanotechnology product portfolio.