Vicept Therapeutics, Inc., a privately held specialty biopharmaceutical company, announced positive results from a pharmacodynamic and pharmacokinetic clinical trial of the company's lead product V-101, a topical cream under investigation for the treatment of erythema in patients with rosacea.
The double-blinded, placebo-controlled, crossover clinical trial of 22 patients with rosacea was designed to evaluate the bioavailability of V-101 and provide preliminary evidence of efficacy as measured by improvement in moderate to severe erythema, the bright redness of the skin associated with rosacea. V-101 had a side effect profile similar to placebo and V-101's active ingredient was not detectable in study participants' plasma, a strong indication of the product's overall tolerability and safety profile. Additionally, the study results were positive for all endpoints, demonstrating a clinically and statistically significant improvement in treating the erythema associated with rosacea.
"This important study demonstrated that V-101 has a good safety profile and provides statistically significant evidence of effectiveness in treating the erythema of rosacea," said Dr. Neal Walker, president and chief executive officer of Vicept. "We look forward to advancing our clinical program into phase II and continuing our efforts to develop this product for the 16 million people in the United States who live with this common, chronic skin condition every day."
"Rosacea is devastating to people who live with it and the primary complaint is erythema, the red sunburn appearance that accompanies the disease," said James Leyden, M.D., Professor Emeritus, University of Pennsylvania and lead investigator. "To date, there are no FDA approved treatments for this manifestation of the disease and V-101 offers a novel approach that, if successful, would address this unmet medical need."
Rosacea is a common, chronic condition of the skin that is estimated to affect more than 16 million people in the United States and more than 45 million people worldwide. The disorder appears most commonly in fair-skinned individuals of northern, eastern European or Celtic.