Velocity Pharmaceutical Development, LLC ("VPD") and Tigercat Pharma, Inc., ("Tigercat") announced today that they 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 licensed to VPD from Merck in 2012.
Tigercat Pharma, Inc., is a largely "virtual" company which was created to hold the ownership of the VPD-737 development program. Tigercat is funded by Velocity Pharmaceutical Holdings, LLC, and Remeditex Ventures, LLC. The VPD-737 development program is managed under contract by VPD.
VPD is a pharmaceutical development organization dedicated to rapidly advancing promising drug candidates to clinical proof of concept using a highly virtual management model. VPD seeks to acquire promising drug candidates, generally within a year of their entering human clinical trials or after initial human clinical data have been generated. VPD then manages a highly virtual development program for each drug candidate intended to generate convincing human proof of concept data (generally by conducting a phase 2 clinical trial). Following successful human proof of concept, VPD then seeks a large pharmaceutical company acquirer for each program. VPD is staffed by a seasoned team of clinical drug developers with expertise identifying attractive drug candidates, target markets, and designing and managing outsourced clinical trials. This expert team manages multiple single asset companies to remove the costly overhead and misaligned incentives present in traditional biotechnology company structures. VPD operates on a rapid decision principle, which identifies drug candidates with the greatest promise and repurposes capital from those that don't work out early in the process. VPD believes this new capital-efficient model will yield attractive new drugs to treat patients with significant unmet clinical needs. The company is located in South San Francisco, California. More information is available at www.vpd.net.
Velocity Pharmaceutical Holdings, LLC, is an entity funded by CMEA Capital that makes investments in highly virtual, project-focused pharmaceutical development companies that are managed by Velocity Pharmaceutical Development, LLC. More information is available at www.vpd.net and www.cmea.com.
Remeditex is a company that seeks to develop opportunities in need of commercial validation, guidance, and capital. Its mission is to develop early stage biomedical science and make Texas and Colorado a preferred location for biotechnology companies, venture capitalists, and entrepreneurs by accelerating the pace of commercialization of biomedical research; help create and support a thriving biotechnology industry; attract biotech venture capital to Texas and Colorado; and achieve significant returns to support the next generation of promising science. More information is available at www.remeditex.com.