Tobira Therapeutics Announces Presentations Related to Cenicriviroc's Development Program in NASH at the American Association for the Study of Liver Diseases Annual Meeting

SOUTH SAN FRANCISCO, Calif., Oct. 1, 2015 /PRNewswire/ -- Tobira Therapeutics, Inc. (NASDAQ: TBRA), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel treatments for liver and inflammatory diseases, today announced upcoming data presentations at the AASLD Annual Meeting (the Liver Meeting®), being held in San Francisco, CA from November 13-17, 2015.

"The strides being made in the hepatology community to address the unmet needs of patients with liver disease are unprecedented," said Eric Lefebvre, M.D., chief medical officer of Tobira Therapeutics. "For the first time, Tobira will be presenting PK and safety data from a Phase 1 study of cenicriviroc co-administered with pioglitazone, an insulin sensitizer that has demonstrated activity in NASH. These data will be an important first step in showing that cenicriviroc, which directly targets inflammation and fibrogenesis, can potentially be combined with metabolically-directed agents in NASH. In the meantime, we continue preparing for the initiation of further combination studies in 2016."

Poster Presentation Details

Presentation Date/Time: Tuesday, November 17, 2015; 8:00 a.m. – 12:00 p.m. PT

Title: Cenicriviroc and Pioglitazone Co-administration Shows Favorable Pharmacokinetics and Safety in Healthy Subjects
Authors: M. Gottwald, C. Galloway, M. Willett, W. Chang, W. Chang, E. Lefebvre

Title: Dual CCR2/CCR5 Antagonist Cenicriviroc Leads to Potent and Significant Reduction in Proinflammatory CCR2+ Monocyte Infiltration in Experimental Acute Liver Injury
Authors: O. Krenkel, T. Püngel, J. Mossanen, C. Ergen, F. Heymann, C. Trautwein, F. Tacke, E. Lefebvre

About Cenicriviroc (CVC) and Non-alcoholic Steatohepatitis (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 believes this novel approach will establish CVC as both a single-agent and as a cornerstone treatment in multi-therapy regimens for NASH, for which there is currently no approved drug.

CVC is currently being evaluated in Tobira's fully enrolled global Phase 2b CENTAUR study (identifier NCT02217475) and the company expects to announce the study's primary endpoint in the third quarter of 2016. CENTAUR is comparing CVC to placebo in 289 patients with NASH and liver fibrosis. CVC has been granted Fast Track status in patients with NASH and liver fibrosis, the patient population at highest risk of progression to cirrhosis. The CENTAUR study includes surrogate endpoints identified as suitable for registrational studies in findings of an FDA-AASLD workshop reported in Hepatology. To date, approximately 600 subjects have been dosed with CVC in Phase 1 and Phase 2b clinical studies, including 115 HIV infected subjects on treatment for up to 48 weeks.

NASH is an emerging health crisis impacting 3% to 5% of the U.S. population and 2% to 4% globally. It is the fastest growing cause of liver cancer and liver transplant in the United States due to the rise in obesity. Additionally, this population is estimated to be three to five times larger than the size of the population with hepatitis C in the United States.

About Tobira Therapeutics

Tobira is a clinical-stage biopharmaceutical company focused on the development and commercialization of therapies to treat liver disease, inflammation, fibrosis and HIV. The company's lead product candidate, cenicriviroc (CVC), is a first-in-class immunomodulator and dual inhibitor of CCR2 and CCR5 being evaluated for the treatment of non-alcoholic steatohepatitis (NASH) and HIV. Learn more about Tobira at www.tobiratherapeutics.com.

Forward Looking Statements

This release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the company's clinical development of cenicriviroc (CVC); the potential timing and outcomes of clinical studies of CVC undertaken now or in the future; the ability of the company to timely source adequate supply of its development products from third party manufacturers on whom the company depends; the company's limited cash reserves and its ability to obtain additional capital on acceptable terms, or at all; the company's ability to successfully progress, partner or complete further development of its programs; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; the company's ability to protect the company's intellectual property; competition; changes in the regulatory landscape or the imposition of regulations that affect the company's products; and other factors listed under "Risk Factors" in the company's other filings with the Securities and Exchange Commission.

Tobira Investor & Media Contact:
Ian Clements, PhD
+1 (650) 351-5013
[email protected]

Canale Communications Media Contact:
Pam Lord
+1 (619) 849-6003
[email protected]

SOURCE Tobira Therapeutics, Inc.