SOUTH SAN FRANCISCO, Calif., April 21, 2016 /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 oral data presentations at the International Workshop on NASH Biomarkers in Washington DC and DDW 2016 in San Diego. The International Workshop on NASH Biomarkers is being held on April 29-30, 2016. DDW 2016 (Digestive Disease Week) is being held from May 21-24, 2016. Further details can be accessed on the International Workshop on NASH Biomarkers website at: http://expertmedicalevents.com/event/upcoming/nash-biomarkers/program/ and the DDW website at: http://ddw-2016.org.
"The definitive diagnosis of non-alcoholic steatohepatitis, or NASH, currently requires a liver biopsy. To foster the clinical development of new therapies, there is an urgent need to develop non-invasive, laboratory-derived tools to identify patients with fibrotic NASH, which are the focus of pivotal studies," said Scott L. Friedman, M.D., Chief of the Division of Liver Diseases and Dean of Therapeutic Discovery at the Icahn School of Medicine at Mount Sinai. "Laboratory and liver histology data from screening in CENTAUR were analyzed and indicated highly positive predictive values of validated serum biomarkers such as APRI and FIB-4, suggesting that these scores can aid in the identification of patients with fibrotic NASH and may be used to simplify patient care while reducing the number of screening biopsies."
International Workshop on NASH Biomarkers Oral Presentation Details
Presentation Date/Time: April 29, 2016; 9:15 a.m. ET
Title: Need for Biomarker Development in NAFLD
Author: Eric Lefebvre
DDW Oral Presentation Details
Presentation Date/Time: May 23, 2016; 8:30 a.m. PT
Title: APRI and FIB-4 Index Scores Can Enrich for Subjects with Fibrotic Non-alcoholic Steatohepatitis (NASH) in Clinical Trials – the CENTAUR Trial Data
Authors: Arun J. Sanyal, Vlad Ratziu, Zachary D. Goodman, Eric Lefebvre, Jeffrey Vest, Mildred D. Gottwald, Laurent Fischer, Scott L. Friedman
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), primary sclerosing cholangitis (PSC) and as an adjunctive therapy to standard of care in HIV. Tobira's pipeline also includes evogliptin, a selective DPP-4 inhibitor, which it plans to develop for NASH in combination with CVC. Learn more about Tobira at www.tobiratx.com.
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) and evogliptin (EVO); the potential timing and outcomes of clinical studies of Tobira's product candidates 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
Canale Communications Media Contact:
+1 (619) 849-6003
SOURCE Tobira Therapeutics, Inc.