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HOME » PRODUCT DEVELOPMENT: MBI 594AN
 MBI 594AN - Treatment of Acne MBI 594AN is a novel, topical antibiotic for the treatment of acne. MBI 594AN is currently in Phase II stage of clinical development. Acne Background Acne is a skin disease that can result in severe scarring of the face, neck and back. While not life-threatening, the characteristic papules, nodules and pustules of severe acne can persist for years and have serious adverse psychosocial effects including depression and withdrawal from society. 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 acne. The most important bacterium associated with acne is Propionibacterium acnes (P. acnes). Antibiotic resistance in P. acnes strains has been reported worldwide. In fact, the incidence of antibiotic resistant P. acnes has increased dramatically from 20% in 1978 to 60% in 1996.  Propionibacterium acnes The US market for prescription antiacne medications is expected to approach approximately US$1.2 billion in 2002. Current therapy for acne includes topical antibiotics and the use of systemic antibiotics approved for other indications, yet increasing resistance to these antibiotics is severely limiting their use. Topical and systemic retinoids (derivatives of vitamin A) are widely prescribed as a treatment for moderate to severe acne. However, these compounds, particularly in systemic form, can have significant side effects. MBI 594AN Development Program Results from our preclinical research program demonstrated that MBI 594AN, our drug product for the treatment of acne, was non-toxic and non-irritating in animal models. In addition, MBI 594AN demonstrated excellent activity against resistant P. acnes strains, suggesting that this agent may be more effective than currently available antibiotics. In January of 2000 we initiated a two-part Phase I clinical trial of MBI 594AN. Phase Ia was designed to assess the safety, tolerability and absorption of MBI 594AN in acne patients. Phase Ib was aimed at establishing the antimicrobial activity of MBI 594AN in healthy volunteers who were colonized with P. acnes. We completed both parts of the Phase I trial in June, 2000. MBI 594AN showed effectiveness in reducing P. acnes on the skin with no resistance arising during the course of the trial. In November of 2000 we initiated a Phase IIa clinical trial for MBI 594AN. The randomized, double-blind study enrolled 75 acne patients, with twice-daily dosing over a six-week period, using either one of two formulations of MBI 594AN (2.5% and 5%) or the product's alcohol-based vehicle alone ("placebo"). The trial was designed to provide an indication of efficacy and to assess safety and tolerability, without being powered for statistical significance. In summary, the preliminary data showed:
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