- New phase 2a trial for CCR5 antagonist -
PRINCETON, N.J. and SAN DIEGO, April 9 /PRNewswire/ -- Tobira Therapeutics Inc., a clinical stage biotechnology company committed to the research and product discovery against life-threatening and life-altering infectious diseases, today announced that it has initiated a proof-of-concept study for TAK-652, a CCR5 antagonist, in HIV-infected, antiretroviral therapy-experienced, CCR5-naive patients. The study is being conducted under an investigational new drug (IND) application filed with the U.S. Food and Drug Administration (FDA).
This phase 2a randomized, double-blind, placebo-controlled study will evaluate the antiviral activity, safety and pharmacokinetics of TAK-652 by enrolling 40 therapy-experienced, CCR5-naive HIV-1-infected patients into one of four escalating dose groups ranging from 25mg to 100 once daily, administered for 10 days. Each dose group of the study will enroll 10 patients’ 8 receiving TAK-652 and two receiving placebo. Approximately thirteen sites in Argentina and the United States will conduct this clinical trial.
“Initiating the proof-of-concept study for TAK-652 is an important step for Tobira Therapeutics and we are very pleased with this progress,” said James Sapirstein, CEO. “Our commitment to the development of new medicines for infectious diseases, and HIV in particular, remain a focus for Tobira Therapeutics.”
About Tobira Therapeutics, Inc.
Tobira Therapeutics is a private biopharmaceutical company which is focused on developing and commercializing innovative antiviral compounds to treat HIV disease. The company was founded in 2006 by Eckard Weber, MD, a partner at the venture capital firm Domain Associates, to develop novel treatments for HIV disease. Tobira has assembled a highly experienced management team with decades of clinical and commercial development experience specifically in HIV/AIDS drug development.
CONTACT: Antoinette Bobbitt of Tobira Therapeutics Inc., +1-609-897-1102,
abobbitt@tobiratherapeutics.com
Web site: http://www.tobiratherapeutics.com/
