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news.MacroChem has announced positive interim results from its ongoing multi-center open-label Phase II efficacy study of EcoNail, a topical antifungal lacquer for the treatment of onychomycosis or nail fungus.
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Presented data is for patients who completed 24 weeks of treatment in an ongoing 48-week, US trial. A protocol-mandated, external expert panel assessed clinical photographs of 37 onychomycosis patients who completed 24 weeks of EcoNail treatment, and 20 (54%) showed evidence of clinical improvement, defined as an increase in uninvolved nail area. At week 24, 100% of patients had cultures that were negative for dermatophyte growth.
The panel observed no signs of local irritation related to the once-daily EcoNail treatment. In the judgment of the panel, the consensus was that 12 of 37 (32%) patients demonstrated significant (greater than or equal to 25%) clinical improvement.
Michael Goldfarb, attending physician for the department of dermatology at the University of Michigan, said: “In a field where clinical trials are challenging, from both an operational and a regulatory perspective, this study is producing an exemplary dataset.
“The clinical improvement observed so far in this patient population, especially in some individuals, impressed me as a practitioner who has limited options, whether oral or topical, to offer patients with onychomycosis. The absence of clinical signs of local irritation is especially notable in light of the high need for safe, as well as effective, topical treatments in this field.”