Blueberry Therapeutics receives clearance from the FDA to proceed with the clinical investigation of BB2603

MACCLESFIELD, England–(BUSINESS WIRE)–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.

ENDS

Notes to Editors

About Blueberry Therapeutics Limited

Blueberry Therapeutics Ltd., incorporated in November 2011, is a drug discovery and development company focused on developing innovative nanomedicines for difficult to treat skin and nail infections. The company is using its state-of-the-art nanotechnology to develop high value medicines where a reduced dose and improved drug delivery is needed, to overcome existing efficacy, tolerability and safety profile concerns.

Blueberry Therapeutics combines expert in-house resources with selected outsource partners and collaborators to take projects through from preclinical research onto de-risked human clinical proof of concept and then on to the market. For more information, please visit http://www.blueberrytherapeutics.com

Blueberry Therapeutics, Alderley Park, Nether Alderley, Macclesfield, Cheshire, SK10 4TG, United Kingdom

© Blueberry Therapeutics Ltd is registered in England & Wales number 7839535.

Date of preparation: August 2018 | PR-BBT004

Contacts

Blueberry Therapeutics Limited Media Contact
Elle Bell – Onyx Health

[email protected]
Tel: +44 (0) 191 640 3638