Velocity Pharmaceutical Development, LLC ("VPD") and Tigercat Pharma, Inc., ("Tigercat") have met all regulatory requirements from Germany's BfArM to initiate a Phase II clinical trial of VPD-737 (serlopitant) in patients with prurigo nodularis. Separately, VPD is also conducting a Phase II clinical trial in the United States evaluating VPD-737 in patients with chronic pruritus.
"Prurigo nodularis is a chronic, debilitating dermatological condition that frequently leads to permanent changes to the skin and prevents patients from living a normal and productive lifestyle. Unfortunately, current therapy options for this orphan disease remain poor thus the unmet medical need for a successful treatment alternative for prurigo nodularis and chronic pruritus remains high" said Prof. Dr. Sonja Ständer, the Principle Investigator for the study. Dr. Ständer is professor for Dermatology and Neurodermatology at the Department of Dermatology, and head of the Interdisciplinary Competence Center Chronic Pruritus of the University Hospital Münster, Germany.
"We are excited about Tigercat achieving another important milestone by starting this new clinical trial and look forward to share top-line results from this study and our chronic pruritus trial in early 2015", said Dr. Edward Schnipper, Tigercat's chief medical officer.
The trial is a double-blind, placebo-controlled Phase II study in patients with prurigo nodularis, an orphan disease. The study is designed to determine the safety, tolerability, and efficacy of VPD-737, an NK-1 receptor antagonist, and will be conducted at four sites in Germany.
VPD-737 (serlopitant) was exclusively licenced to VPD from Merck in 2012.