Ocera Therapeutics, Inc. (NASDAQ: OCRX) is a clinical stage
biopharmaceutical company focused on the development and commercialization of
proprietary compounds to treat acute and chronic orphan liver disease. The
company’s leading product candidate, OCR-002, is currently being studied in
phase IIb clinical trials for the treatment of hyperammonemia and resultant
hepatic encephalopathy in patients with acute liver failure and
acute-on-chronic liver disease. In early testing, OCR-002 has been shown to
lower circulating blood levels of ammonia by enabling alternate metabolic
pathways in the muscles and kidney, helping the candidate achieve orphan drug
designation and fast track status from the FDA.
When commercialized, OCR-002 will provide Ocera with access
to a severely underserved market within the biopharmaceutical industry.
According to Medscape, acute liver failure, though uncommon, is a debilitating
condition in which rapid deterioration of liver function in a previously
healthy individual causes encephalopathy, or alteration of mental status, in
addition to a host of potentially life-threatening symptoms. Without liver
transplantation, the current survival rate of acute liver failure is just seven
percent.
In the first quarter of 2015, Ocera ramped up clinical
studies of its product pipeline in a push toward the eventual market approval
of OCR-002. As of March 31, the company reported cash and cash equivalents of
just over $46 million, which will be essential to the continued development of
its promising product candidate. Based on its current guidance, Ocera expects
that it will have sufficient cash to fund operations into the fourth quarter of
2016.
“I am pleased to report positive developments in our
clinical pipeline so far this year, including progress with both the
intravenous and oral formulations of OCR-002,” Dr. Linda Grais, president and
chief executive officer of Ocera, stated in a news release. “Serious liver
disease impacts millions of patients and their families. We at Ocera
Therapeutics are committed to finding much needed alternatives to current
treatments for these patients.”
The company’s operating strategy includes future licensing
of certain rights to its drug development programs following achievement of
proof of concept, which should provide Ocera with expanded commercialization
capabilities and a limited risk profile while maintaining the potential for
significant returns. For prospective shareholders, this strategy could provide
a platform for strong financial growth moving forward. Look for Ocera to turn
its focus toward the development of strategic industry partnerships as it
inches toward the future market approval of OCR-002.
For more information, visit www.ocerainc.com
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