-Both Phase II studies achieve 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 results from a second Phase II clinical trial evaluating the dose-response relationship of two concentrations of V-101 cream, a topical cream for the treatment of Type I Rosacea (Erythematous Rosacea). The results demonstrated a statistically significant improvement (p= <0.01) in the primary endpoint, a reduction in facial erythema or redness, over a twelve hour period versus placebo cream in patients with erythematous rosacea. Further, V-101 demonstrated a safety profile similar to placebo cream. This is the second of two V-101 Phase II studies to achieve statistical significance in the primary endpoints.
“This study was designed to optimize the concentration of V-101 Cream in preparation for Phase III clinical testing in patients with erythematous rosacea and to further characterize the duration of the clinical effect,” said Dr. Neal Walker, President and Chief Executive Officer of Vicept. “In addition to the favorable dose-response results, the data also demonstrated a statistically significant outcome (p = <0.05) in the anticipated Phase III primary end point of a two ordinal reduction in the combined clinician and patient assessments. Based on these two positive studies, Vicept has requested a meeting with the FDA to discuss advancing the clinical development of V-101.”
Study V-101-ROSE-206 was a prospectively randomized, multi-centered, double-blinded, vehicle-controlled, Phase II clinical trial designed to evaluate the dose-response relationship of two concentrations of V-101 cream vs. vehicle (placebo) for the treatment of the erythema associated with rosacea. A total of 85 patients with moderate to severe erythema participated at three investigational centers in the United States. Patients were divided among three groups and randomly administered one of two concentrations of V-101 cream or vehicle cream. 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 rosacea 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 erythematous 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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