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Experimental Molecule Demonstrates Efficacy for Treatment of Acne: Presented at AAD

By Alison Palkhivala

SAN FRANCISCO, CA -- March 24, 2003 -- A new agent representing a novel drug class may be on the way for the topical treatment of acne, particularly the inflammatory variety.

H. David Friedland, MBB, CH, vice president of clinical and medical affairs at Micrologix Biotech, Inc., in Vancouver, British Columbia, Canada, investigated the use of a novel, cationic antimicrobial peptide they have developed and call MBI 594AN. He presented the results in a poster here on March 23^rd at the 61^st Annual Meeting of the American Academy of Dermatology.

The topical product is in phase III study for the prevention of central venous catheter-related bloodstream infection. The same active substance has been shown to have excellent activity against Propionibacterium acnes, said Dr. Friedland.

In the acne clinical study, 75 individuals aged at least 13 years with acne vulgaris defined as 25 to 100 inflammatory and 20 to 100 non-inflammatory lesions were randomised to treatment with a 2.5% strength topical solution of MBI 594AN, a 5% solution of MBI 594AN or the vehicle alone with no active drug. Patients applied the agent twice daily to acne-affected areas after washing with a non-bactericidal soap. Patients were assessed every week for 42 days, with the final visit conducted on Day 43.

By the end of the study period, patients using the 2.5% strength solution had a reduction in total lesion counts that was greater than that seen in patients using the vehicle alone (P=0.04). Treatment was more effective on the inflammatory than the non-inflammatory lesions. Among patients using the active drug, reductions in inflammatory lesions exceeded 40%, while reductions in non-inflammatory lesions ranged from about 10 to 20%.

Based on physicians' global assessment, just over 70% of patients experienced at least a fair improvement while taking the active drug, and 11% to 29% had a good to excellent improvement.

No serious adverse events were seen among patients. Patients using the active drug had more mild, transient dryness than those using the vehicle, and one patient had a drug reaction consisting of moderate itching, mild edema, erythema and irritation.

"The very good thing about the peptide is that it's not affected by other antimicrobial resistance mechanisms," said Dr. Friedland. "The peptide is also cidal, so it kills bacteria very quickly. … In the lab, it's almost impossible if not impossible to induce resistance to the peptides."


[Study title: Double-Blind Randomized Vehicle-Controlled Study to Assess the Safety and Efficacy of MBI 594AN in the Treatment of Acne Vulgaris. Abstract p51]

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