Almirall announces that the pivotal study for P-3058 has met the primary endpoint in an onychomycosis phase III trial.
Almirall, S.A (ALM) has announced 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. P-3058 was generally safe and well tolerated.
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.
P-3058 10% terbinafine nail solution is an antifungal product for treatment of dermatophyte-induced onychomycosis formulated for drug application to nails. The technology is based on a water soluble semi-synthetic derivative of chitosan which acts as a film-forming agent, does not require nail filing and is easily removed with water.
P-3058 is the first terbinafine nail lacquer solution for onychomycosis treatment. The product has a convenient posology: applied once-daily for 1 month, and then once-weekly for 48 weeks.
Terbinafine is an antimycotic agent that inhibits the biosynthesis of the principal sterol in fungi, ergosterol, at the level of squalene epoxidase. Squalene epoxidase inhibition results in ergosterol depleted fungal cell membranes (fungi static effect) and the toxic accumulation of intracellular squalene (fungicidal effect).
This phase III study was a multicentre, randomised, 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.
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.
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