NEW YORK, July 24 MacroChem Corporation(OTC Bulletin Board: MACM) today announced results of a Phase 2 clinical trialinvolving 37 patients who completed a 48-week, U.S. multi-center, open-labelefficacy and safety study of EcoNail, a topical antifungal lacquer for thetreatment of onychomycosis (nail fungus). The composite primary efficacyendpoint of the trial was "complete cure" defined as negative mycology(negative fungal culture and negative KOH) and clear nail (as determined byexpert panel review of clinical photographs). EcoNail is the company'spatented, topically-applied lacquer which contains the antifungal econazoleand MacroChem's enhancer SEPA(R).
A protocol-mandated, external expert panel assessed clinical photographsof 37 onychomycosis patients who completed 48 weeks of EcoNail treatment. Thepanel observed that 24 patients (65%) showed evidence of clinical improvement,defined in the protocol as an increase in uninvolved (clear) nail area. Whilenone of the 37 patients reached all criteria of the composite primaryendpoint, 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 48weeks of once-daily treatment with EcoNail, 100% of patients had cultures thatwere negative for dermatophyte growth. Eight of the 37 patients (22%) achievedthe secondary endpoint of negative mycology (negative fugal culture plusnegative KOH evaluation) at 48 weeks. The panel observed no signs of localirritation related to the once-daily EcoNail treatment. During the trial, nopatient required interruption of dosing due to local intolerability. Through56 weeks of observation, no cutaneous adverse events were attributed by theinvestigators to EcoNail.
The laboratory of Boni Elewski, MD, Professor of Dermatology at theUniversity of Alabama-Birmingham, performed mycological cultures for thistrial. According to Dr. Elewski, "The proportion of patients with negativemycology, that is both negative culture and negative KOH, together with thefact that all the patients had negative cultures at 48 weeks, indicates thatEcoNail has clinically relevant antifungal activity. Consistent with resultsfrom the study's interim analysis, the final results showed that a meaningfulproportion of patients demonstrated progressive clinical improvement andreduction of fungal disease burden. Based on the practical definition of'cure' published in Scher et al in 2007 in the Journal of the American Academyof Dermatology, it is my opinion upon review of the clinical photographs that4 of the 37 (11%) patients achieved a cure. Minimal onycholysis and nosubungual debris in the clinical setting of negative mycology is for practicalpurposes cured." Dr. Elewski added, "If we exclude 6 patients whose baselinenail involvement in my opinion was too severe to warrant entry into thistrial, then 4 of 31 (13%) would be considered cured." The clinical andmycologic findings to date suggest reason for optimism and further study tofully characterize the benefits of this new topical treatment in a very commonand difficult to cure condition."
Michael Goldfarb, MD, Attending Physician, Department of Dermatology atthe University of Michigan, who assisted MacroChem in the development of theprotocol, noted, "As a practicing dermatologist who has limited treatmentoptions to offer patients with onychomycosis, whether oral or topical, I wasparticularly impressed with the lack of skin irritation and the progressiveclinical improvement." Dr. Goldfarb added, "There are at least 4 patients inthis trial who, if under my care, I would have considered to have shownresolution of their disease. These factors suggest that this new topical agentcould be an acceptable and valuable treatment for this typically chroniccondition."
Robert J. DeLuccia, Chair