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news.US-based biopharmaceutical firm Matinas BioPharma Holdings has submitted an investigational new drug application (IND) for its lead drug candidate, MAT9001, to the US Food and Drug Administration (FDA) for the treatment of severe hypertriglyceridemia (TG>500mg/dL).
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The company is focused on the development and commercialization of omega-3 fatty acid-based prescription therapeutics for the treatment of cardiovascular and metabolic conditions.
MAT9001 is a prescription-only omega-3 fatty acid medication comprising docosa-pentaenoic acid (DPA) and is specifically designed to provide a differentiated pharmacotherapy to treat dyslipidemia.
Matinas BioPharma chairman of the Board Herbert Conrad said the IND filing is an important step forward for the company as it looks to position MAT9001 as a significantly differentiated product for the treatment of hypertriglyceridemia and dyslipidemia.
"As we enter the clinical stage of development, our focus is to continue to advance MAT9001 rapidly through its planned clinical program," Conrad said.
The company intends to start its Phase III registration program in 2015.
Matinas BioPharma president and chief executive officer Roelof Rongen said the MAT9001 IND filing is a truly significant milestone for the company.
"This filing is another step in the execution of our development strategy. We remain focused on operational excellence as we prepare to initiate the first human trial of MAT9001 and plan to advance our lead development candidate into a Phase 3 registration program next year," Rongen said.