MCNICOL PJ, RUBINCHIK E, PASETKA C, BARBER R, LOPEZ J, FRIEDLAND HD; Interscience Conference on Antimicrobial Agents and Chemotherapy (41st : 2001 : Chicago, Ill.).
Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2001 Dec 16-19; 41: abstract no. F-349.
Micrologix Biotech Inc., Vancouver, BC, Canada
BACKGROUND: MBI 594AN is a novel, synthetic, cationic antimicrobial peptide in a Phase II trial for treatment of acne vulgaris. The 75 acne patients in the randomized, double-blinded, placebo-controlled, dose-ranging efficacy study are undergoing daily treatment for six weeks with physician-assessed reduction in acne lesion counts as the primary endpoint. Prior to a clinical trial, MBI 595AN was extensively characterized by conducting the following studies. Methods and RESULTS: Susceptibility testing of 27 sensitive and antibiotic-resistant strains ofPropionibacterium acnes, the primary organism associated with acne lesions, showed MBI 594AN has excellent activity against this organism. A geometric mean MIC value of 2.3 microg/ml was obtained. Attempts to promote resistance of P. acnes to MBI 594AN in vitro were unsuccessful. After 20 passages of P. acnes strains in the presence of drug, MIC values were essentially unchanged. Similarly, resistance was not observed for P. acnes strains isolated from Phase I trial volunteers, who had been exposed for 6 weeks to MBI 594AN. The anti-inflammatory activity of MBI 594AN was assessed using mouse models of TPA-induced ear edema and oxazolone-induced delayed type hypersensitivity reaction. In these studies, the effect of MBI 594AN was compared to the corresponding vehicle treatment. Topical application of 5% MBI 594AN resulted in 35% to 60% and 23% reduction in inflammatory response in the TPA and oxazolone model, respectively. CONCLUSION: MBI 594AN is effective against acne target organisms and does not promote resistance. These characteristics combined with pronounced anti-inflammatory activity suggest a favorable Phase II outcome anticipated in Q3 2001.
Publication Types:
Keywords:
- Acne Vulgaris
- Administration, Topical
- Animals
- Double-Blind Method
- Humans
- In Vitro
- Mice
- Microbial Sensitivity Tests
- Motor Activity
- Treatment Outcome
Other ID:
UI: 102269883
From Meeting Abstracts