Benzinga | Jan 4, 2021 07:20AM EST

Matinas BioPharma Announces FDA Conditional Acceptance of LYPDISO as the Brand Name for MAT9001

Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today announced the U.S. Food and Drug Administration (FDA) has conditionally accepted LYPDISO(tm) as the proposed brand name for MAT9001, the Company's investigational drug for treatment of cardiovascular and metabolic conditions. The Company also announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance, approving the Company's application to register the LYPDISO brand name as a federal trademark.

The name LYPDISO (pronounced "Lip-DEE-so") was developed in compliance with FDA's Guidance for Industry, Contents of a Complete Submission for the Evaluation of Proprietary Names. Based on the development program, which included research with physicians and pharmacists, as well as an international name assessment, the Company believes LYPDISO is a proprietary name with strong marketing potential that is also consistent with FDA's goal of preventing medication errors and potential harm to the public by ensuring that only appropriate proprietary names are approved for use. A request for proprietary name review and final approval for LYPDISO will be included when Matinas submits a New Drug Application (NDA) for MAT9001.

"We are pleased that the FDA has conditionally accepted the name LYPDISO for our lead product candidate and that we have also received a Notice of Allowance from the USPTO toward registering this brand as a federal trademark," said Jerome D. Jabbour, Chief Executive Officer of Matinas. "These meaningful steps align with our continued clinical progress, as well as preparation for the commercialization of LYPDISO, if approved. We eagerly await topline data from our ENHANCE-IT head-to-head study vs. Vascepa(r) in the first quarter of 2021, followed by the commencement of our Phase 3 program for LYPDISO in the second half of 2021. We continue to believe that LYPDISO, if approved, would provide an important and potentially best in class product to help treat patients suffering from cardiovascular and metabolic conditions."