24 March 2022
Blueberry Therapeutics provides R&D update and reports progress across dermatology portfolio
- Phase 2 trial with BB2603 in onychomycosis: continues, with initial readout expected in Q1 2023
- Phase 3 trial with BB1202 for tinea pedis: ready to enter late-stage clinical development with Blueberry seeking advice from regulatory agency to finalise trial design
- Phase 1 trial with BB0107 for atopic dermatitis: expected to move into the clinical phase in the second half of 2022
Alderley Edge, 24 March 2022 – Blueberry Therapeutics Limited (“Blueberry” or “the Company”), a pharmaceutical company focused on developing innovative, topical medicines to treat dermatological conditions, today provides an update on its research and development activities. The Company is progressing a de-risked portfolio of best-in-class assets addressing high value markets, including onychomycosis (fungal nail infection), tinea pedis (athlete’s foot) and atopic dermatitis (eczema).
Blueberry has applied innovative formulation technologies to improve the delivery of existing drugs through the skin and nail. These enhanced formulations support better efficacy, safety and compliance, representing significant improvements over existing prescribed and over-the-counter treatments, with the potential to reduce dose and cost of goods.
Dr John Ridden, CEO of Blueberry Therapeutics, commented: “Over the past year, we have made significant clinical progress with our lead programmes, BB2603 for onychomycosis and BB1202 for the treatment of tinea pedis, with further important milestones expected this year. We anticipate that recruitment into our ongoing Phase 2 study with BB2603 will be complete by July 2022 with the primary endpoint data anticipated in Q1 2023.
“For BB1202, in tinea pedis, we are currently designing a Phase 3 clinical programme to support registration, with the aim of initiating a Clinical Trial Application in Europe in 2022.
“Finally, we are moving our novel formulation, BB0107 for atopic dermatitis through preclinical development and are on track to nominate for clinical development later this year.
“We have a vision to discover, develop and bring to market, high value medicines which offer patients treatment for common dermatological conditions, and we’re delighted with the progress that we have made.”
Blueberry is currently developing its candidate BB2603 for onychomycosis, which the Company believes offers a superior treatment option, avoiding the systemic exposure and toxicities associated with current blockbuster oral treatments, by enabling enhanced topical delivery in an easy-to-use spray. The duration of treatment with BB2603 will be much shorter (three months) than the 12‑18 months needed for existing topicals. In 2019, the Company gained approval from Competent Authorities and Ethics Committees in Germany, Poland and the Czech Republic to conduct a Phase 2 trial. The trial was initiated in early 2020 across 25 sites, but had to be paused in March 2020, prior to any patients being treated, due to the COVID-19 pandemic. In early 2021, it was restarted, with the first patient randomized to treatment in March 2021. Blueberry is currently recruiting patients and anticipates that patient numbers needed to assess primary endpoints will be reached by July 2022 with initial readout early in 2023. This Phase 2 trial will support continuation in Phase 3 registration trials.
Blueberry is developing BB1202 for the treatment of tinea pedis. The Company believes that BB1202, with its enhanced method of delivery and retention in the skin, offers the potential for lower doses to be administrated which rapidly permeate into the skin, without being washed off. The cutaneous spray solution also offers important advantages over currently available topical treatments, which often leave excess residue on the skin. BB1202 is ready to enter Phase 3 clinical development, and Blueberry is now working with the relevant regulatory agency to finalise the design of its clinical programme. The Company aims to initiate a Clinical Trial Application in Europe in 2022.
Blueberry’s preclinical team have also been developing BB0107, a novel formulation for atopic dermatitis, a major area of clinical focus and significant unmet need in the dermatology field. BB0107 offers multiple therapeutic actions – antimicrobial and antifungal activity, as well as emollient properties that support improved skin barrier function. Blueberry aims to develop a topical treatment that avoids many of the issues associated with existing treatments to meet patient needs across the spectrum of atopic dermatitis. The Company aims to move BB0107 into the clinical phase in the second half of 2022.