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MICROLOGIX INITIATES PHASE I CLINICAL TRIAL FOR ACNE TREATMENT
Vancouver, January 24, 2000 - Micrologix Biotech Inc. is pleased to announce it has initiated Phase I clinical trials in the US to evaluate the safety and antimicrobial activity of MBI 594AN in the treatment of acne. Micrologix plans to complete the trials by mid-2000 and to initiate Phase II trials during the second half of the year.
The Phase I trial of MBI 594AN, a new drug product from Micrologix's Bactolysin (cationic peptide) series of compounds, will include: (a) an open-label study to determine the safety and tolerability of MBI 594AN when applied topically to 20 acne patients; and (b) a randomized, double-blind, placebo-controlled trial to assess the antimicrobial effect of MBI 594AN when applied topically to 36 healthy volunteers who are colonized with Propionibacterium acnes (P. acnes). The results of this study will allow Micrologix to compare the activity of MBI 594AN to other drugs approved for the treatment of acne.
Acne is the most common inflammatory skin disease of adolescence and early adulthood, with nearly 20% of all visits to dermatologists related to its evaluation and treatment. Data from the 1996 US census indicate that approximately 45 million Americans are affected by this condition. While not life-threatening, the characteristic papules, nodules and pustules of acne can persist for years and have serious adverse psychosocial effects including depression and withdrawal from society.
For more than 30 years, antibiotic agents have been used extensively for the treatment of acne. They are believed to exert their therapeutic effect by reducing the population of the bacterium P. acnes and its mediators of inflammation, as well as by producing direct anti-inflammatory effect. The main concern over the use of antibiotics for treating acne is the emergence of resistant organisms. In fact, published studies indicate that the overall incidence of antibiotic-resistant P. acnes has increased from 20% in 1978 to 62% in 1996. Due to their unique mode of action, cationic antimicrobial peptides overcome current drug-resistance mechanisms and bacteria do not develop resistance to these compounds as demonstrated in pre-clinical studies. These qualities offer significant advantages for the use of MBI 594AN in acne treatment, particularly in situations where currently marketed antibiotics are failing.
Micrologix Biotech Inc. is a biopharmaceutical company developing novel drugs to treat severe and life-threatening diseases-particularly those caused by antibiotic-resistant microorganisms. Micrologix has been granted fast track designation by the US Food and Drug Administration for MBI 226, an antimicrobial drug product for the prevention of central venous catheter-related bloodstream infections which the Company anticipates will be in Phase III clinical trials in Q3 2000. The Company also has drug development programs for the treatment of eye infections and other serious diseases and plans to initiate an additional Phase I trial in the first half of 2000. Micrologix's portfolio of drug candidates is based on improved analogs of the anti-infective peptide compounds found in the host-defense systems of most life forms.
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