Print 09 August 2016
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--
"We are excited about the results of the CENTAUR trial, which we believe is the first study to prospectively meet an endpoint recommended for Phase 3 studies to support marketing authorization, namely ‘an improvement in fibrosis by at least one stage without worsening of NASH.' This is an important milestone as fibrosis is a key predictor of mortality and liver-related events. We are confident about our path forward, and we look forward to discussing the Phase 3 study with regulators and presenting the CENTAUR data at a medical meeting later this year," said
Upcoming Target Milestones
Second Quarter 2016 Financial Results
2016 Six-Month Results
Cash, Cash Equivalents & Restricted Cash
Conference Call Information
The company will host a conference call today to review Tobira's business highlights and financial results for the first quarter of 2016 beginning at
About the CENTAUR Study
The CENTAUR study (NCT02217475) is a Phase 2b multinational, randomized, double-blind study comparing CVC to placebo for the treatment of NASH in adults with liver fibrosis. The trial enrolled 289 patients, all with moderate to advance fibrosis (F1-F3). The primary endpoint was improvement of NAFLD Activity Score at the one year time point. The two key secondary endpoints included: ‘complete resolution of steatohepatitis and no worsening of fibrosis' (worsening defined as progression of NASH CRN fibrosis stage) and ‘improvement in liver fibrosis by at least one stage with no worsening of steatohepatitis' (no worsening of lobular inflammation or hepatocellular ballooning grade). In
CENTAUR exclusively enrolled adults at increased risk of progression to cirrhosis. Of the 289 patients enrolled the majority (67%) had moderate (F2) to severe fibrosis (F3), the population that currently evaluate in contemporary Phase 3 studies.
About Cenicriviroc (CVC)
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. Because of this unique mechanism of action, targeting two of the main engines driving NASH, CVC has the potential to play a differentiated role in the management of NASH and may form the cornerstone of NASH combination treatment strategies, both as a single agent and in combination with other agents targeting metabolic pathways. CVC has been granted Fast Track status in patients with NASH and liver fibrosis, the patient population at highest risk of progression to cirrhosis.
In addition to CENTAUR, CVC is also being evaluated in the PERSEUS study (identifier NCT02653625), a Phase 2 proof-of-concept study of CVC in patients with primary sclerosing cholangitis, a rare inflammatory liver disease.
About Non-Alcoholic Steatohepatitis (NASH)
NASH is a severe type of non-alcoholic fatty liver disease (NAFLD), which is characterized by the accumulation of fat in the liver with no other apparent causes. NASH occurs when the accumulation of liver fat is accompanied by inflammation and cellular damage. The inflammation can lead to fibrosis (scarring) of the liver and eventually progress to cirrhosis, portal hypertension, liver cancer, and eventual liver failure.
NASH is an emerging health crisis impacting 3% to 5% of the
Tobira is a clinical-stage biopharmaceutical company focused on the development and commercialization of therapies for non-alcoholic steatohepatitis (NASH) and other liver diseases. The company's lead product candidate, cenicriviroc (CVC), is a first-in-class immunomodulator and dual inhibitor of CCR2 and CCR5 in late-stage development for the treatment of NASH, a serious liver disease that can progress to cirrhosis, liver cancer and liver failure. CVC is also being investigated to address primary sclerosing cholangitis (PSC), a disease which causes inflammation and scarring of the bile ducts, eventually leading to serious liver damage. 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.
Tobira® is a registered trademark owned by
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) 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 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 other filings with the
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