MacroChem Announces Positive Interim Phase 2 Data for EcoNail in the Treatment of Onychomycosis54% of patients showed clinical improvement after 24 weeks of once-daily treatment; no skin irritation observed
WELLESLEY HILLS, Mass., November 06, 2007 /PRNewswire-FirstCall/ -- MacroChem Corporation (www.macrochem.com) today announced positive interim Phase 2 data for patients who completed 24-weeks of treatment in an ongoing 48-week, U.S. multi-center open-label 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(R).
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.
Mycologic cultures for this trial were performed in the laboratory of Boni Elewski, MD, Professor of Dermatology at University of Alabama-Birmingham. According to Dr Elewski, "The negative dermatophyte cultures, coupled with the overall clinical improvement observed, suggests the promise of this new treatment for a very common and difficult-to-cure condition. Onychomycosis is a progressive infection in which fungal involvement often spreads; however, in this study, I was particularly impressed that the fungal burden was reduced. We look forward to the completion of this Phase 2 trial, and to future definitive efficacy trials."
Michael Goldfarb, MD, Attending Physician, Department of Dermatology at the University of Michigan, who assisted MacroChem in the development of the protocol, added: "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."
"We feel this trial is as robust a Phase 2 study as has been performed in this field", stated Robert DeLuccia, President and CEO of MacroChem. He continued, "Its design and conduct includes the use of onychomycosis experts as investigators at US sites, strict enrollment criteria with all patients required to be fungal-culture positive at entry, the use of registration-type primary endpoints and treatment duration, monthly photographs for documentation, and the innovative use of an external expert panel to review clinical data, all of which give us confidence in the anticipated results from this study when completed, and in the reproducibility of data in the Phase 3 program currently envisioned. Additionally, I am extremely pleased to note the lack of observed skin irritation."
DeLuccia further noted, "These positive interim results are an important milestone for our Company and very encouraging as we look forward to completing the full study next year." 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 and commercial opportunity in the marketplace for new treatments for onychomycosis. With these data we will step-up our partnering discussions for the next phase of clinical development."
About the EcoNail Phase 2 trial and Onychomycosis
Patients participating in the EcoNail study, which is being conducted under MacroChem's U.S. Investigational New Drug application filed with the FDA, will receive 48 weeks of treatment at U.S. sites and will undergo efficacy assessments using standard criteria of nail appearance and mycology. 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 3 as soon as possible.
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.
MacroChem Corporation is a specialty pharmaceutical company that develops and seeks to commercialize pharmaceutical products. Our lead product candidate is EcoNail, a topically applied SEPA-based econazole lacquer for the treatment of onychomycosis, a condition commonly known as nail fungus. We recently acquired exclusive worldwide license rights to pexiganan, a novel topical anti-infective for the treatment of diabetic foot infection, which has already completed two Phase 3 trials. Our other clinical stage product candidate, Opterone(R), is a topically applied SEPA-based testosterone cream designed to treat male hypogonadism. Our pipeline of clinical-stage and early-stage product candidates is based on our SEPA, MacroDerm(TM) and DermaPass(TM) drug delivery technologies. For more information visit our website, www.macrochem.com.
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, www.macrochem.com.
Contact: MacroChem: Bernard Patriacca - VP/CFO (781) 489-7310 Investor Relations: The Investor Relations Group, Inc. Christine Berni/ Joseph Triunfo, (212) 825-3210 Media: Bill Douglass/ Michaela Heller, (212) email@example.com firstname.lastname@example.org email@example.com firstname.lastname@example.org email@example.com
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Posted: November 2007