Velocity Pharmaceutical Development, LLC ("VPD") and Tigercat Pharma, Inc., ("Tigercat") today announced that the first patient has been dosed in a double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of VPD-737 (serlopitant), administered orally 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.
Dr. Edward Schnipper, Tigercat's Chief Medical Officer, stated "We are delighted to announce that the first patient has been dosed in this important Phase II study. Prurigo nodularis is a debilitating disease and the current standard of care does not effectively address this condition. We believe VPD-737 is a promising pharmacological option and we are eager to see results from this study, which along with data from our chronic pruritus study, will be available in 2015."
The trial is a double-blind, placebo-controlled Phase II study in sixty 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 is underway at four sites in Germany. Patients in the study will receive either 5 mg of VPD-737 or placebo, taken once daily, for a period of eight weeks.
VPD-737 was exclusively licensed by Merck to VPD 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 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 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.