Aug 23 2007, 7:00 AM EST
News source: Business Wire
CollaGenex Pharmaceuticals, Inc. (NASDAQ:CGPI) today announced results of a Phase 2 dose-finding study designed to evaluate the safety and efficacy of Col-118 for the treatment of erythema. Erythema is a bright skin redness associated with erythematous rosacea and other dermatological conditions. Col-118 is a topical formulation that incorporates a compound believed to reduce erythema by constricting enlarged blood vessels in facial tissue. The Phase 2 clinical study demonstrated a highly statistically significant dose-response relationship of Col-118 in the reduction of erythema, with a side effect profile similar to the vehicle control.
The double-blinded, placebo-controlled, Phase 2 study enrolled 110 patients at 6 centers. The study had four arms, and patients were treated with one of three concentrations of Col-118 or a vehicle control. The treatment duration was 28 days, with a 28-day follow up. Patients applied Col-118 or vehicle daily throughout the treatment period. On Days 1, 14 and 28, each patient applied Col-118 once in the investigator's office and was assessed at set intervals during the day using various scores, including Clinical Erythema Assessment.
The primary clinical endpoint of this study was a reduction in average Clinical Erythema Assessment (CEA) score across all visits compared to baseline. The CEA is a five-point scale ranging from 0 to 4, with grade 0 described as clear skin with no signs of erythema and grade 4 described as severe erythema characterized by a fiery redness. At baseline, all patients had moderate to severe erythema and scored either grade 3 or 4.
The study successfully demonstrated a strong dose response relationship and achieved its primary endpoint. The average reductions in CEA in patients who had received the mid and the high doses of Col-118 were substantially greater across all visits than that of patients receiving the vehicle control. At the Day 28 visit, the average reduction in CEA in patients who had received the high dose was 1.6 at peak efficacy compared to an average peak reduction in the vehicle of 0.7, with a p-value of less than 0.001. At peak efficacy on Day 28, the average reduction in CEA in patients who had received the mid dose was 1.3 (p less than 0.05), and the average reduction in CEA in patients who had received the low dose was 1.0 (p=0.2).
Klaus Theobald, M.D., Ph.D., chief medical officer of CollaGenex, said, "We are extremely pleased with the outcome of our Phase 2 study. We achieved our primary endpoint and also observed a strong dose response relationship, with a very high degree of statistical significance. The onset of action was rapid, and beneficial effects were maintained for at least six hours. At peak efficacy, 38% of patients in the high dose group had CEA scores of 0 or 1, indicating that they were clear or near clear of erythema. Clinically, these results are very meaningful and, with this data in hand, we expect to begin our Phase 3 testing in the first quarter of 2008."
James Leyden, M.D., Professor Emeritus, University of Pennsylvania, and lead investigator of the study, said, "Col-118 appears to be the first effective treatment for the redness (flushing and blushing) associated with rosacea. Currently, there are no effective treatments for patients who suffer from this aspect of rosacea. If future studies confirm these results, this treatment should be approved by FDA. Once approved, Col-118 will offer an important new treatment to millions of rosacea patients."
Colin Stewart, president and chief executive officer of CollaGenex, stated, "The results of this trial provide clear evidence that Col-118 offers significant clinical benefits in the treatment of erythema with an excellent side effect profile. If our clinical development program is successful and Col-118 is ultimately ap
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