July 25, 2008
MacroChem Reports Positive Results From Phase II Onychomycosis Trial
MacroChem has announced positive results from a Phase II clinical trial involving 37 patients who completed a 48-week, US multi-center, open-label efficacy and safety study of EcoNail, a topical antifungal lacquer for the treatment of onychomycosis.
The composite primary efficacy endpoint of the trial was 'complete cure' defined as negative mycology and clear nail. EcoNail is the company's patented, topically-applied lacquer which contains the antifungal econazole and MacroChem's enhancer Sepa.A protocol-mandated, external expert panel assessed clinical photographs of 37 onychomycosis patients who completed 48 weeks of EcoNail treatment. The panel observed that 24 patients (65%) showed evidence of clinical improvement, defined in the protocol as an increase in uninvolved (clear) nail area.
While none of the 37 patients reached all criteria of the composite primary endpoint, the consensus judgment of the panel was that 15 of 37 patients (41%) demonstrated significant (greater than or equal to 25%) clinical improvement. All patients had fungal culture-proven nail infections at entry, but after 48 weeks of once-daily treatment with EcoNail, 100% of patients had cultures that were negative for dermatophyte growth.
Approximately eight of the 37 patients (22%) achieved the secondary endpoint of negative mycology (negative fugal culture plus negative KOH evaluation) at 48 weeks. The panel observed no signs of local irritation related to the once-daily EcoNail treatment. During the trial, no patient required interruption of dosing due to local intolerability.