Tobira Therapeutics Doses First Patient in CENTAUR, A Phase 2b Study of Cenicriviroc in Patients with Non-Alcoholic Steatohepatitis

SOUTH SAN FRANCISCO, Calif., Oct. 13, 2014 /PRNewswire/ -- Tobira Therapeutics, Inc., a clinical-stage biopharmaceutical company advancing cenicriviroc (CVC) in liver disease and HIV, announced today that it has dosed the first patient in its CENTAUR study of patients with non-alcoholic steatohepatitis (NASH) and liver fibrosis, a disease affecting approximately 3-5 percent of the U.S. population. The initiation of the CENTAUR study follows the completion of a Phase 1 safety study in subjects with liver cirrhosis. To date, approximately 580 subjects have been dosed with CVC in Phase 1 and Phase 2b clinical studies, including 115 HIV-1 infected subjects on treatment for up to 48 weeks.

"Initiating a Phase 2b clinical study with CVC in NASH, a potentially life threatening liver disease for which there are no approved therapies, is an important milestone for Tobira," commented Dr. Laurent Fischer, chairman and CEO of Tobira Therapeutics. "CVC has previously demonstrated dual inhibition of CCR2 and CCR5, key regulators of signaling pathways in NASH that lead to liver damage and disease. This study will help further determine if these drivers are responsive to CVC and advance our clinical investigation of a potential treatment option for patients with NASH." 

CVC is an oral, once-daily, potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are intricately involved in the inflammatory and fibrogenic pathways in NASH that cause liver damage and often lead to cirrhosis, liver cancer or liver failure. Tobira has demonstrated significant anti-fibrotic activity of CVC in preclinical models of liver and kidney disease.

"The rising prevalence of obesity in the United States and Western Europe is associated with an alarming increase in NASH leading to advanced liver fibrosis and cirrhosis. Cenicriviroc – with its favorable safety profile and scientific evidence of an anti-inflammatory and anti-fibrotic effect – is the first drug in its class in development to target the damage and scarring resulting from fat and inflammation in the liver," stated Scott Friedman, M.D., chief of the Division of Liver Diseases and Dean of Therapeutic Discovery at the Icahn School of Medicine at Mount Sinai, and a world renowned NASH expert. Dr. Friedman is the CENTAUR study chairman.

The CENTAUR study is a randomized, double-blind Phase 2b study of a single 150mg tablet of CVC given once daily versus placebo in patients with NASH and liver fibrosis. CENTAUR is a global study with planned treatment centers across North America, Europe and Australia. The study will enroll approximately 250 patients and will evaluate the improvement of NASH and liver fibrosis at both one and two years as compared to placebo. For additional information on the CENTAUR study, please visit clinicaltrials.gov using the identifier NCT02217475.

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. A Phase 2 trial currently underway is studying CVC in patients with NASH. Tobira also plans to advance CVC in a fixed-dose combination for HIV type 1 infection through Phase 3 development and commercialization in collaboration with a strategic partner or with non-dilutive financing. 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] 

SOURCE Tobira Therapeutics, Inc.