Efficacy from phase IIb acne study

Statistically significant data validates anti-acne properties of Micrologix MBI 594AN

Vancouver, Canada-based Micrologix Biotech, a developer of anti-infective drugs, has achieved statistically and clinically significant efficacy results from its Phase IIb study of MBI 594AN, a topical drug candidate under development as a first-in-class prescription treatment for acne.

The Phase II study was designed to evaluate acne lesion count reductions at various time points (3, 6, 9, and 12 weeks), comparing MBI 594AN (1.25% and 2.5%) with the alcohol vehicle. MBI 594AN 2.5% achieved statistically significant superiority at 6 weeks in reducing all three lesion parameters measured: inflammatory lesions (p=0.004), non-inflammatory lesions (p=0.037), and total lesions (p<0.001). A Physician's Global Severity Assessment, the fourth parameter measured, also resulted in clear superiority of the product as compared with the vehicle. The drug was extremely well tolerated, with no serious drug-related adverse events encountered in the study.

'The data from this Phase IIb efficacy study confirms the results achieved in the previous Phase IIa study,' said Dr David Friedland, vice president of Clinical Development for Micrologix. 'We now have two well-controlled, double-blind human clinical trials that validate the anti-acne properties of MBI 594AN, providing us information needed to advance to Phase III studies.'

Based on these results, further development work for MBI 594AN will continue, including the design of future clinical and non-clinical studies required for NDA submission. Requirements prior to Phase III studies include product manufacturing, an end-of-Phase II meeting with the FDA, and the design of Phase III trials. It is expected that final decisions about the size, duration, and other attributes of future studies will be made in conjunction with a licensing partner and/or upon meeting with the FDA. Micrologix anticipates these activities can be completed by mid-2004, with Phase III trials commencing in the second half of 2004.

About MBI 594AN

MBI 594AN is an antimicrobial cationic peptide demonstrating rapid in vitro and ex vivo antibacterial effect against Propionibacterium acnes (the organism associated with acne). Potential advantages of MBI 594AN over currently available prescription topical acne products include rapid action, reduction of both inflammatory and non-inflammatory acne lesions, bactericidal activity with no demonstrated induction of resistance, rapidly effective against multi-resistant P.acnes, no evidence of toxicity, and ease of use. With the large, growing acne market, the increasing bacterial resistance seen with current acne therapies, and the clear need for a novel, first-in-class treatment, MBI 594AN represents a solid product opportunity for further development.

Acne

It is estimated that 45m people in the United States have acne, which is the most common skin disorder of adolescence and early adulthood (ages 15-24 years) with a prevalence of approximately 85%. The U.S. market for prescription acne medications was approximately US$1.6bn in 2002 and is forecast to increase to US$1.9bn by 2006. Prescription medications available for the treatment of acne in the U.S. can be divided into topical prescription therapies (approximately a US$800m market) and systemic (oral) therapies (approximately a US$500m market) and over-the-counter topical products. Generally, mild to moderate cases are treated with topical medications, with more severe cases being treated with systemic or a combination of topical and systemic therapies. The global market for prescription anti-acne products reached US$2.0bn in 2001 and is forecast to reach revenues of US$3.3bn in 2006. Prescription drugs for acne treatment or prevention fall into three general categories: antibiotics, retinoids, and drugs that affect hormone levels. Problems exist with most of these treatment options. Antibiotics are not as useful as they once were as Propionibacterium acnes (P. acnes), the bacteria most commonly associated with acne, has developed resistance to many antibiotics. A significant market opportunity exists for an innovative, effective, and safe topical agent that has no side effects and avoids the problem of antibiotic resistance.