Blueberry Therapeutics Limited Announce Positive Results from a Phase I/II Clinical Trial
Blueberry Therapeutics Limited (“Blueberry Therapeutics”), a modern drug discovery and development company committed to the development of innovative new therapies for the treatment of common and difficult to treat dermatological disorders, today announces that BB2603 has successfully met its primary endpoint from the recently completed Phase I/II trial of 46 patients with both onychomycosis (fungal nail infection) and concomitant tinea pedis (athletes foot).
The trial was a single centre, vehicle and active controlled, randomized investigation, undertaken in Germany, with primary endpoints of systemic pharmacokinetics and secondary endpoints in safety and local tolerability. Efficacy signals were assessed at day 42 for tinea pedis and week 52 for onychomycosis.
The study met all its primary and secondary endpoints to assess pharmacokinetic, safety and local tolerability. The topical nano-formulation BB2603 was shown to have an excellent safety profile with good local tolerability and no systemic exposure. Efficacy assessments were highly encouraging with demonstrable anti-fungal activity against dermatophytes, the causative pathogens for both onychomycosis and tinea pedis. Clinical improvements were noted in both indications.
John Ridden, CEO, commented "we are delighted that our Phase I/II trial of BB2603 has met both its primary and secondary endpoints and that we are able to use our nanotechnology platform to develop medicines such as BB2603 for diseases where there is a significant medical need, particularly where improved drug delivery or optimised treatment regimes can overcome tolerability and safety concerns and better suit the patient needs”.
Blueberry Therapeutics has a number of pipeline treatments focussing on common high value dermatological diseases where there is a significant clinical need for treatments with improved efficacy, safety, tolerability and patient compliance.
Forward Looking Statement
Based on these Phase I/II results and the successful series B raise, Blueberry Therapeutics will initiate a large phase IIb dose finding efficacy study for BB2603 in onychomycosis. The company plans to apply for an Investigational New Drug Application (IND) with the FDA in early 2019.
CMS Medical Limited (a wholly owned subsidiary of CMS) has the rights to develop and commercialise BB2603 in China, Korea and Mongolia, with the rights to expand into other Asian markets. Blueberry Therapeutics retains rest of world rights to develop and commercialise BB2603 and all pipeline products.