– Statistically Significant Data from Phase 2 Study Support Safety and Efficacy of Once Daily Dosing of NK-1 Antagonist, VPD-737 (serlopitant) —
SOUTH SAN FRANCISCO, Calif., Dec. 17, 2014 /PRNewswire/ — Tigercat Pharma, Inc. today announced positive results of a Phase 2 study evaluating the investigational oral NK-1 receptor antagonist VPD-737 (serlopitant), for the treatment of patients with severe, chronic itch who are unresponsive or inadequately responsive to the current standard of care, including topical steroids and antihistamines.
The primary efficacy endpoint was percent change in Visual Analog Scale (VAS) itch score from baseline, comparing drug to placebo for each dose group. Statistically significant reduction in VAS scores were seen in both the 1mg and 5mg dose groups. The response was durable over the entire treatment period. VPD-737 is safe and well tolerated.
Gil Yosipovitch, M.D, Professor Chair of Dermatology and Director of the Temple Itch Center at Temple University School of Medicine, a principal investigator for the Phase 2 study remarked: “Today is an important day for patients who suffer from severe, chronic pruritus. The results of this study give tremendous hope for the millions of patients who suffer from this debilitating condition, which erodes their quality of life. I look forward to the further development of VPD-737 and hopefully adding it to the treatment armamentarium for patients suffering from intractable pruritus.”
Edward Schnipper, M.D., a Founder and Chief Medical Officer at Tigercat Pharma, Inc. remarked: “We are very pleased with the conduct and outcome of this study. We are continuing development of this drug for patients who desperately need a treatment regimen more efficacious than the current standard of care.”
About the Phase 2 Study
The Phase 2 study was a randomized, double-blind, parallel group, placebo-controlled, dose-finding and efficacy study of VPD-737 (serlopitant) for the treatment of patients with chronic pruritus.
The study enrolled 257 patients from 25 sites in the United States with VAS of 7 or greater at baseline (on a scale of 1 to 10). Patients were males and females between 18 and 65 years with confirmed chronic pruritus for a period lasting more than six weeks. Patients were unresponsive or inadequately responsive to topical steroids or antihistamines.
The patients were randomized into four equal groups of the following doses: 0.25, 1, 5 mg and placebo tablets administered daily for 6 weeks. The primary efficacy endpoint was the percent change in VAS from baseline, comparing drug to placebo for each dose group. The primary analysis was conducted on an Intent-to-Treat (ITT) population.
Tigercat utilized the services of TKL Research, Inc., a contract research organization, to conduct the trial.
ABOUT TIGERCAT PHARMA, INC.
Tigercat Pharma, Inc., is a clinical stage biopharmaceutical company focused on the development and commercialization of VPD 737(serlopitant), an NK-1 receptor antagonist, currently in late stage clinical development for the treatment of chronic pruritus. Tigercat investors included Velocity Pharmaceutical Holdings, LLC, and Remeditex Ventures, LLC. More information is available at www.tigercatpharma.com.
ABOUT VELOCITY PHARMACEUTICAL DEVELOPMENT, LLC
Velocity Pharmaceutical Development (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.
ABOUT VELOCITY PHARMACEUTICAL HOLDINGS, LLC
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.
ABOUT REMEDITEX VENTURES, LLC
Remeditex 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.
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