SOUTH SAN FRANCISCO, Calif., Jan. 7, 2016 /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, announced that the U.S. Food and Drug Administration (FDA) and Health Canada have accepted the company's Investigational New Drug (IND) application and Clinical Trial Application (CTA), respectively, for cenicriviroc (CVC) for the treatment of primary sclerosing cholangitis (PSC).
PSC is a rare disease, estimated to affect fewer than 50,000 people in the U.S. PSC is characterized by progressive inflammation, fibrosis and stricture formation in liver ducts often associated with Inflammatory Bowel Disease (IBD).
The company plans to initiate a Phase 2 study later in the first quarter of 2016. The single-arm, open label, proof-of-concept clinical trial will evaluate the effects of 24 weeks of treatment with CVC 150 mg in approximately 25 patients with PSC. The primary endpoint will be the change of serum ALP (alkaline phosphatase) levels.
"Acceptance of the IND and CTA is an important step toward our goal of building a platform with cenicriviroc, a compound we believe can address multiple immuno-inflammatory and fibrotic diseases," said Laurent Fischer, M.D., chief executive officer of Tobira. "We believe CVC has promising clinical potential in patients with primary sclerosing cholangitis, and we look forward to the first clinical data in this indication to guide future development in this rare and life-threatening disease, for which no treatments have been approved and may require a liver transplant."
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 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, PSC and other liver disease.
About Primary Sclerosing Cholangitis (PSC) PSC is a rare, idiopathic chronic cholestatic liver disease of unknown etiology characterized by progressive destruction of bile ducts with life-threatening complications. More than 60% of cases occur in men. Inflammation and fibrosis of the bile ducts leading to formation of a beaded pattern and multifocal bile duct strictures are the hallmark of this progressive disease, leading to destruction of the bile ducts, fibrosis, cirrhosis, portal hypertension, cancer and ultimately hepatic decompensation resulting in liver failure.
Median survival for PSC patients has been previously estimated as eight to 12 years from diagnosis in symptomatic patients, depending upon stage of the disease at the time of diagnosis. Complications involving the biliary tree are common and include cholangitis as well as ductal strictures and gallstones, both of which may require frequent endoscopic or surgical interventions. PSC is often complicated by the development of malignancies, with cholangiocarcinoma being the most common.
Despite evaluation of multiple treatments, liver transplant is currently the only treatment shown to improve clinical outcomes. Ursodiol is often used for the treatment of PSC due to improvements in liver biochemistry following initiation of therapy. Despite general biochemical improvement, ursodiol has not been shown to improve transplant-free survival and, at high doses, has been associated with increased risk for serious complications. PSC is the fourth leading indication for liver transplant. However, the post-transplant recurrence rate of PSC has been shown to be as high as 20%.
Learn more about PSC at http://www.pscpartners.org/
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 primary sclerosing cholangitis (PSC). For NASH, CVC is 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 and in use in current Phase 3 studies. 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.
Learn more about Tobira at www.tobiratherapeutics.com.
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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.
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