Tobira Therapeutics Doses First Subject in Phase 1 Clinical Trial of Cenicriviroc and Pioglitazone

SOUTH SAN FRANCISCO, Calif., Jan. 20, 2015 /PRNewswire/ -- Tobira Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of novel treatments for liver and inflammatory diseases, announced today that it has dosed the first subject in a Phase 1 study to evaluate the pharmacokinetics and safety in healthy subjects of cenicriviroc (CVC) and the diabetes medication pioglitazone, both when administered alone and in combination. The study supports Tobira's larger clinical program of CVC in non-alcoholic steatohepatitis (NASH), a disease associated with multiple comorbidities, including diabetes.

Pioglitazone is approved to improve glycemic control in patients with Type 2 diabetes mellitus and has previously been studied in NASH. In addition, Tobira believes that the eventual approach to treating NASH will include multiple therapies to address the comorbidities of NASH, including Type 2 diabetes.

The study is designed as an open label, fixed-sequence, three-period crossover study in two randomized groups of 10 healthy subjects each. For additional information on the study, visit www.clinicaltrials.gov, and use the identifier NCT02342067.

CVC is currently being evaluated in Tobira's Phase 2b CENTAUR study (identifier NCT02217475). CENTAUR is a randomized, double-blind study designed to compare CVC to placebo in approximately 250 patients with NASH and liver fibrosis, including patients with Type 2 diabetes mellitus.

"Type 2 diabetes mellitus is a disease commonly associated with non-alcoholic steatohepatitis or NASH and NASH patients with Type 2 diabetes are often at greater risk of progression to advanced liver disease," said Laurent Fischer, M.D., chairman and CEO of Tobira Therapeutics. "This study will allow us to further build CVC's safety profile in combination with agents that are currently used in the NASH population."

Tobira also plans to conduct a study, named ORION (identifier NCT02330549), to examine the effects of CVC on peripheral and adipose tissue insulin sensitivity in obese subjects with prediabetes and suspected non-alcoholic fatty liver disease (NAFLD).

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-1. 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 non-alcoholic steatohepatitis (NASH) and HIV-1. Tobira is actively enrolling patients in a Phase 2b clinical trial called CENTAUR to evaluate CVC in patients with NASH and liver fibrosis. On January 14, 2015, Tobira and Regado Biosciences (NASDAQ: RGDO) entered into a merger agreement that is expected to close in the second quarter of 2015. Learn more about Tobira at www.tobiratherapeutics.com.

For information about pioglitazone, see Full Prescribing Information for ACTOS (pioglitazone) tablets at http://www.takeda.us/products/.

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
[phone]
[e-mail]

Mark Corbae
Canale Communications
[phone]
[e-mail]

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SOURCE Tobira Therapeutics, Inc.