Phase II Trial Of EcoNail For Treatment Of Onychomycosis

Main Category: Clinical Trials / Drug Trials
Also Included In: Infectious Diseases / Bacteria / Viruses;  Seniors / Aging;  Pain / Anesthetics
Article Date: 14 Apr 2007 - 13:00 PDT

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MacroChem Corporation (OTCBB: MACM.OB) announced the completion of patient enrollment in a 40 patient U.S. multi-center open label Phase II efficacy study of EcoNail, a topical antifungal lacquer for the treatment of onychomycosis (nail fungus). EcoNail is the company's patented lacquer which contains the antifungal econazole and MacroChem's enhancer SEPA®.

Patients participating in the study, which is being conducted under MacroChem's U.S. Investigational New Drug application filed with the FDA, will receive 48 weeks of treatment and will undergo efficacy assessments using standard criteria of nail appearance and mycology. However, the Company will collect and evaluate 24-week interim data later this year. This trial was specifically designed, with the assistance of well-known onychomycosis experts, to address three important objectives: to assess early signs of efficacy, to maintain robust clinical endpoints in the full study, and, if successful, to facilitate advancement to Phase III as soon as possible.

"Full enrollment in this Phase II study is an important milestone in advance of our planned interim assessment later this year. An earlier than originally intended evaluation of clinical data from a subset of patients treated for 24 weeks may be conducted to facilitate planning for potential future clinical development", stated Robert DeLuccia, President and CEO of MacroChem. He continued, "I believe that the recent precedent-setting deal activity for topical nail fungus products in clinical development by two major international pharmaceutical companies reflects the high level of interest in the marketplace for new treatments for onychomycosis."

DeLuccia further noted: "If we can develop a topical therapy without the treatment-limiting side effects experienced with the current market-leading oral products and with better efficacy than the only currently available topical product, we believe this could be a substantial commercial opportunity. We also believe that an effective, well-tolerated and easy-to-use topical onychomycosis therapy could both attract patients currently receiving other treatments and also expand the existing market to include patients who are not currently being treated."

Onychomycosis affects 20-30 million people in the United States alone, including nearly half of those over age 70. Untreated, the disease causes nails to thicken, resulting in localized pressure-related pain. Topical treatments currently marketed in the U.S. reportedly succeed in fewer than 12 percent of patients, and existing systemic treatments, which are effective in less than half of all cases, have known toxicity. Despite the shortcomings of these existing drugs, sales of treatments for onychomycosis top $1.5 billion annually worldwide.

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Article adapted by Medical News Today from original press release.
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About MacroChem

MacroChem Corporation is a specialty pharmaceutical company that develops and seeks to commercialize pharmaceutical products. Currently, our portfolio of proprietary product candidates is based on our drug delivery technologies: SEPA®, MacroDerm(TM) and DermaPass(TM). Currently, we have two clinical stage investigational new drugs: EcoNail, our lead product, for the treatment of onychomycosis (fungal infections of the nails) and Opterone, for the treatment of male hypogonadism. In addition to our SEPA technology, we are also evaluating applications for MacroDerm, our patented series of polymers that impede penetration of active ingredients through the skin. For more information visit our website, http://www.macrochem.com.

Forward-Looking Statements

With the exception of historical information contained in this press release, the matters described herein are forward-looking statements that involve risks and uncertainties. MacroChem's actual results may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed or referred to in the section entitled "Risk Factors" in MacroChem's Annual Report on Form 10-K, as well as those discussed elsewhere therein, and include, without limitation, risks regarding product development, the timing and results of clinical trials, the regulatory approval process, capital requirements, financial condition, patent protection and dependence on third parties for development and licensing arrangements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. MacroChem undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. For more information visit our website, http://www.macrochem.com/.

Contact: Rachel Anscher
MacroChem