Blueberry Therapeutics has received an investigational new drug (IND) clearance from the Food and Drug Administration (FDA) to proceed with the clinical development of BB2603 for the treatment of onychomycosis.
The IND is a crucial milestone in the continued development of BB2603, a nanoformulated, topical form of terbinafine for the treatment of onychomycosis (fungal toenail). With the IND in place the company has initiated a Phase IIb international, multicentre double-blinded study.
The primary outcome of this study is to look at the efficacy BB2603 in onychomycosis, with a secondary dose finding outcome also being investigated.
John Ridden, CEO said: “Having received clearance from the FDA we are looking forward to the opportunity to 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 in our path to commercialisation of our nanotechnology product portfolio.”
With BB2603, Blueberry Therapeutics aim 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, meaning lower doses can be used and systemic side effects are minimised.