Tobira Therapeutics Announces Data Presentations Highlighting Cenicriviroc at HEP DART 2015

December 8, 2015

SOUTH SAN FRANCISCO, Calif., Dec. 8, 2015 /PRNewswire/ -- Tobira Therapeutics, Inc. (NASDAQ: TBRA), a biopharmaceutical company developing novel treatments for non-alcoholic steatohepatitis (NASH) and other serious immuno-inflammatory and fibrotic diseases, today announced that data relating to cenicriviroc will be presented at HEP DART 2015 in Wailea, HI.

Tobira and its key collaborators presented two abstracts and a sponsor presentation on cenicriviroc (CVC), the company's lead CCR2/5 antagonist; CENTAUR, the company's Phase 2b study evaluating CVC in NASH; and enhanced liver fibrosis (ELF) index data from the company's completed HIV Phase 2b study.

"The clinical data presented at HEP DART continues to expand our understanding of how CVC may play an important role for the treatment of NASH with liver fibrosis," said Eric Lefebvre, M.D., chief medical officer at Tobira. "We are presenting for the first time baseline characteristics from the CENTAUR study, which was fully enrolled earlier this year with subjects with NASH and liver fibrosis who are therefore at high risk of progression to cirrhosis. Thus, the study population of CENTAUR is well aligned with the growing unmet need since this population is most likely to require and benefit from treatment. Additionally, this careful patient selection is expected to reduce the likelihood of spontaneous disease improvement and allow for detection of a potentially greater difference between CVC treatment and placebo."

Poster Presentations

• CENTAUR, a Phase 2b Efficacy and Safety Study of Cenicriviroc in Adults with Non-alcoholic Steatohepatitis and Liver Fibrosis at Increased Risk of Progression to Cirrhosis
Authors: S Friedman, A Sanyal, Z Goodman, E Lefebvre, M Gottwald, L Fischer, V Ratziu

In this poster the authors describe the baseline characteristics of patients enrolled in the CENTAUR study:

A total of 812 subjects were screened and 289 were enrolled across 11 countries.
• The mean age of enrolled subjects is 54.1 years (standard deviation [SD] 10.59).
•
The mean BMI is 33.86 kg/m2 (SD 6.49). Most of the subjects (88.6%) have a BMI > 25 kg/m2 with at least one metabolic syndrome criterion.
• The majority of the subjects have type 2 diabetes (52.9%).

With respect to liver histology characteristics:
•
The majority of subjects have a NAS > 5 (74.0%) and moderate-to-severe fibrosis, i.e. NASH CRN stage 2-3 (66.8%).
• Subjects have a total mean NAFLD Activity Score (NAS) of 5.3 (SD 1.03) with mean scores of 1.5 (SD 0.50) for hepatocellular ballooning, 1.4 (SD 0.57) for steatosis and 2.4 (SD 0.57) for lobular inflammation.

• CCR2/CCR5 Antagonism with Cenicriviroc Decreases Fibrosis Scores in HIV-Infected Patients.
Authors: KE Sherman, E Abdel-Hameed and SD Rouster

In this 48-week randomized, double-blind, active comparator Phase 2b study, serum samples from 143 HIV patients were evaluated by an independent group using the enhanced liver fibrosis (ELF) index. Patients were randomized to receive cenicriviroc or efavirenz (control group) with backbone of tenofovir/emtricitabine. Baseline and 48-week serum samples from the study cohort were evaluated using the ELF Index. The ELF Index, which measures key hepatic fibrosis and collagen biomarkers (Procollagen III, TIMP-1, and Hyaluronic Acid) was validated by independent comparison with liver biopsy findings in a separate group of subjects and then applied to the HIV study subjects.

After validation, the ELF index was then used to determine fibrosis scores in 36 subjects treated with CVC 200 mg for 48 weeks versus 16 subjects treated with efavirenz for 48 weeks.

• The mean ELF Index at baseline in the CVC group was 10.53 (SD 2.12) and was 9.13 (SD 0.99) in the efavirenz group.

• After 48 weeks of treatment, the mean ELF index significantly decreased to 8.28 (SD 0.88) in the CVC group (p < 0.0001) but not in the efavirenz group.

Oral Presentation

Cenicriviroc: A Novel Agent Targeting Immuno-Inflammatory Pathways for the Treatment of NASH with Liver Fibrosis.
Presenter: E Lefebvre, Tobira Therapeutics

In this presentation, the author will highlight the pre-clinical and clinical translational evidence for the use of CVC in treating subjects diagnosed with NASH and liver fibrosis. Additionally, the innovative design of the CENTAUR study and the baseline characteristics of subjects enrolled will be described.
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 in completed studies with CVC, 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 U.S. 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 U.S.

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). Learn more about Tobira at www.tobiratherapeutics.com.

Tobira® is a registered trademark owned by Tobira Therapeutics, Inc.

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 its 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 filings with the Securities and Exchange Commission.

Tobira Investor & Media Contact:
Ian Clements, Ph.D.
+1 (650) 351-5013
ir@tobiratherapeutics.com

Canale Communications Media Contact:
Pam Lord
+1 (619) 849-6003
pam@canalecomm.com

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SOURCE Tobira Therapeutics, Inc.