-Statistically significant improvement in primary endpoint of facial redness associated with rosacea-
-Safety profile similar to placebo cream-
MALVERN, Pa.--(BUSINESS WIRE)-- Vicept Therapeutics, Inc. announced today positive study results from a Phase II clinical trial evaluating the dose-response relationship of four concentrations of V-101 cream, a topical cream for the treatment of Type I Rosacea (Erythematotelangiectatic Rosacea). The results demonstrated a statistically significant (p=0.0006) improvement in the primary end point, which was a reduction in facial erythema, over an eight hour period in patients with erythematotelangiectatic rosacea (ETR), versus placebo. Further, V-101 demonstrated a safety profile similar to placebo cream and no evidence of “rebound” or tachyphylaxis was observed.
“These positive data showed that V-101 significantly reduced the redness associated with Type I rosacea (ETR) and demonstrated a favorable side effect profile, further confirming its potential to be the first effective topically applied therapy directed specifically toward the erythema of rosacea,” said Dr. Neal Walker, President and Chief Executive Officer of Vicept. “This is a major milestone for the Company and we are poised and committed to continue the advancement of the V-101 development program.”
Study V-101-ROSE-202 is a prospectively randomized, multi-centered, double-blinded, placebo-controlled, Phase II clinical trial designed to evaluate the dose-response relationship of four concentrations of V-101 cream vs. vehicle (placebo) for the treatment of the erythema associated with rosacea. A total of 183 patients with moderate to severe erythema participated at seven investigational centers across the United States. Patients were divided among five groups and self-administered one of four concentrations of V-101 cream or vehicle (placebo) cream once daily for 28 days. The study also demonstrated that V-101 cream was well-tolerated in these patients, a population of patients with facial skin that is highly sensitive to topical preparations. The safety profile of all the active preparations was similar to that of placebo.
Rosacea is a common, chronic cutaneous disorder that affects over 15 million Americans and over 45 million people worldwide. Erythematotelenagietic rosacea (ETR), Type I, is the most commonly encountered subtype, and is most characterized by frequent episodes of transient facial erythema (flushing) and non-transient, or persistent, erythema. It may also be accompanied by facial edema, burning, or stinging, and sensitivity of the skin and intolerance to topically applied products is common. Rosacea remains a disorder of uncertain etiology and pathogenesis, though the flushing and erythema of ETR are theorized to arise from an abnormal response of the cutaneous blood vessels of the face to neurological, hormonal, thermal, topical, or other stimuli, resulting in an abnormal dilation of facial blood vessels. There is currently no approved topical therapy for the treatment of ETR (erythematotelangiectatic) rosacea.
About Vicept Therapeutics
Vicept Therapeutics, Inc. is a is a privately held specialty pharmaceutical company with a mission to develop the first effective topically applied therapy directed toward the erythema of rosacea and other disorders characterized by redness and or flushing of the skin. The Company is also pursuing the development of topical agents for the treatment and prevention of a number of medical and cosmetic indications including bruising of the skin. The Company is based in Malvern, Pennsylvania and more information can be found by visiting the Company’s website at www.vicepttx.com
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