Tobira Therapeutics' Cenicriviroc Granted Fast Track Designation by the FDA for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients with Liver Fibrosis

SOUTH SAN FRANCISCO, Calif., Jan. 6, 2015 /PRNewswire/ -- Tobira Therapeutics, Inc., a clinical-stage biopharmaceutical company developing cenicriviroc (CVC) in liver disease and HIV, announced today that the United States Food and Drug Administration (FDA) has granted Fast Track designation to CVC for the treatment of nonalcoholic steatohepatitis, or NASH, in patients with liver fibrosis. Tobira is currently enrolling patients in its Phase 2b proof of concept study, entitled "Cenicriviroc Efficacy and Safety Study in Adult Subjects with Nonalcoholic Steatohepatitis and Liver Fibrosis," or CENTAUR (Study 652-2-203; NCT02217475), which is a randomized, double-blind study designed to compare CVC to placebo in approximately 250 patients with NASH and liver fibrosis.

The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs that address serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designation provides increased opportunities to interact and meet with FDA, and increases the likelihood of being eligible for priority review if supported by the clinical data at the time of the submission of the New Drug Application.

"We believe this Fast Track designation is further recognition of both the critical need for effective therapies for patients with NASH and liver fibrosis and of CVC's potential to treat this serious condition," commented Laurent Fischer, M.D., chairman and CEO of Tobira Therapeutics. "The designation of Fast Track for CVC and our CENTAUR clinical program are aligned with recommendations from the joint FDA and American Association for the Study of Liver Disease workshop¹ that identified potentially acceptable surrogate endpoints for clinical studies of agents for NASH and liver fibrosis, a disease for which no treatments are approved. We look forward to continuing our collaboration with the FDA on the development of CVC in patients with NASH and liver fibrosis in the CENTAUR study."

About Tobira Therapeutics

Tobira is a clinical-stage biopharmaceutical company focused on the development and commercialization of therapies to treat liver disease, HIV, fibrosis and inflammation. The company's lead product, cenicriviroc (CVC), is a first in class immunomodulator and dual inhibitor of CCR2 and CCR5 being evaluated for the treatment of nonalcoholic steatohepatitis (NASH) and HIV. CVC's safety and tolerability profile has been evaluated in approximately 580 subjects who have been dosed in Phase 1 and Phase 2 trials, including a safety study in subjects with liver cirrhosis and 115 HIV-1 infected subjects on treatment for up to 48 weeks. Tobira is currently enrolling a Phase 2b clinical trial to study CVC in patients with NASH. Learn more at www.tobiratherapeutics.com.

Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking information and forward-looking statements (collectively "forward-looking statements" within the meaning of applicable securities laws). Such statements, based as they are on the current expectations of management of Tobira Therapeutics and upon what management believes to be reasonable assumptions based on information currently available to it, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond Tobira's control. Such statements can usually be identified by the use of words such as "may," "would," "believe," "intend," "plan," "anticipate," "estimate" and other similar terminology, or state that certain actions, events or results "may" or "would" be taken, occur or be achieved.

Whether actual results and developments will conform with our expectations and predictions is subject to a number of risks, assumptions and uncertainties, many of which are beyond our control, and the effects of which can be difficult to predict. These risks include those inherent in drug development, whether Tobira will be able to obtain financing when needed or on favorable terms, and other risks described in Tobira's filings with the Securities and Exchange Commission. In evaluating any forward-looking statements in this release, Tobira cautions readers not to place undue reliance on any forward-looking statements. Unless otherwise required by applicable securities laws, Tobira does not intend, nor does it undertake any obligation, to update or revise any forward-looking statements contained in this news release to reflect subsequent information, events, results or circumstances or otherwise.

Contacts:

Chris Peetz
Chief Financial Officer
Tobira Therapeutics
(650) 351-5018
[email protected]

Mark Corbae
Canale Communications
(619) 849-5375
[email protected]

¹ Sanyal et al. DOI: 10.1002/hep.27678

SOURCE Tobira Therapeutics, Inc.

Related Links

http://www.tobiratherapeutics.com