- Primary endpoint (negative culture and/or clear nail growth) met with 83.3% response rate
- Secondary endpoints met at Week 52 after 9-months off treatment
On 13 November, Blueberry Therapeutics Limited (“Blueberry” or “the Company”), a pharmaceutical company focused on developing innovative, topical nanomedicines to treat dermatological conditions, announced that BB2603, a novel topical terbinafine antifungal product, has met the primary endpoint in the Phase 2b trial (BBTAF202) in patients with onychomycosis, showing superiority over placebo (vehicle) with a high level of statistical significance.
BBTAF202 was a European trial conducted in 111 subjects with mild to moderate distal subungual onychomycosis (DSO) of the toenail, recruited from sites in Germany, Poland and the Czech Republic. This trial assessed the efficacy, safety and pharmacokinetics of 3 months twice-daily treatment of BB2603-10 versus vehicle, along with 2 lower formulation strengths of BB2603-3 and BB2603-1. A 3‑month treatment duration is considerably shorter than for other topical agents used for onychomycosis (~11 months).
The primary objective was an assessment of early clinical and/or mycological activity of BB2603-10 versus vehicle at Week 16, 1 month after end of treatment. Significantly more subjects treated with BB2603-10 (83.3%) had a response of negative dermatophyte culture and/or clear nail growth at Week 16 compared with those who received vehicle (51.8%, p=0.004). This treatment difference was driven by an early effect of BB2603-10 on negative culture (80.6% vs 40.5%, p<0.001). Growth of clear nail was observed in many subjects as early as Week 4. Clear nail and improvement in the appearance of fungally-infected toenail addresses an important aesthetic need of patients.
Secondary endpoints were assessed at the end of the trial at Week 52, 9 months after the end of the 3-month treatment period. Even after this extended off‑treatment period and the associated risk for mycological recurrence, 64% of patients treated with BB2603-10 had negative culture at Week 52, with 30.6% of patients achieving mycological cure (negative culture and negative microscopy) versus vehicle (5.4%, p=0.005).
The safety and tolerability profile of BB2603 was excellent – there were no drug related adverse events (AEs), no application site reactions, no serious AEs and no AEs leading to treatment discontinuation with BB2603-10. The trial also confirmed no detectable systemic exposure following treatment with BB2603, meaning that there are no systemic safety concerns.
Dr John Ridden, CEO of Blueberry Therapeutics, commented:
“We are excited to announce the successful completion of our Phase 2b trial, which delivered remarkable treatment outcomes following just three months of dosing. Additionally, we are delighted by the exceptional safety observed throughout the study. We believe BB2603 can become a best-in-class topical treatment for onychomycosis. With a well-defined development roadmap in place, we are now in the planning stage for the forthcoming Phase 3 trials.”
Dr Juergen Dobmeyer, Chief Medical Officer of Blueberry Therapeutics, commented:
“Onychomycosis is a notoriously difficult condition to treat with topicals often needing long treatment durations, which some patients struggle to maintain. These positive Phase 2 data with BB2603, which can be applied safely, easily and conveniently with a spray, show real promise.”