Almirall Phase 3 antifungal trial hit primary endpoint

Almirall, S.A (ALM) has announced today that the pivotal study for P-3058 (10% terbinafine nail solution) has met the primary endpoint of complete cure rate and key secondary endpoints in the treatment of mild to moderate onychomycosis. P-3058 was statistically significantly superior to P-3058 nail solution vehicle at Week 60, following a treatment for 48 weeks.

The study included an open label arm of amorolfine 5% nail lacquer. Complete cure rate was numerically in favour of P-3058 nail solution.

Study description

This phase III study was a multicentre, randomized, double-blind, vehicle controlled, parallel-group study to evaluate the efficacy and safety of P-3058 10% terbinafine nail solution versus its Vehicle (double blind) and versus an active comparator (open label).

A total of 953 patients with mild-to-moderate distal lateral subungual onychomycosis (DLSO) caused by dermatophytes involving ≥ 20% to ≤ 50% of the target big toenail area without lunula/matrix involvement were randomised to P-3058, its vehicle, or amorolfine 5% nail lacquer. Patients applied P-3058 nail solution or its vehicle once daily for 4 weeks then once weekly for the remaining 44 weeks of treatment. Amorolfine 5% nail lacquer was applied once weekly for 48 weeks.

Primary Endpoint:

Rate of complete cure at the end of follow up (12 weeks after the 48-week treatment course) defined as composite of negative KOH microscopy and negative culture for dermatophytes and no residual clinical involvement (nail totally clear) of the target nail.

Key Secondary Endpoints:

· Responder rate defined as negative KOH microscopy and negative culture for dermatophytes and ≤ 10% residual involvement of the target toenail at the end of follow up.

· Mycological cure rate defined as negative KOH microscopy and negative culture for dermatophytes of the target toenail at the end of follow up.

Disease

Onychomycosis is a fungal infection of the nail. It is difficult to treat, requiring long-term treatment and good compliance to achieve eradication of the fungus and acceptable clinical out-come.

https://www.marketscreener.com/ALMIRALL-SA-268048/news/Almirall-announces-that-the-Phase-III-trial-of-P-30