Matinas BioPharma Holdings, Inc. Announces FDA Conditional Acceptance of LYPDISO™ as the Brand Name for MAT9001
January 04, 2021 at 07:00 am EST
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Matinas BioPharma Holdings, Inc. announced the U.S. Food and Drug Administration (FDA) has conditionally accepted LYPDISO™ 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.
Matinas BioPharma Holdings, Inc. is a biopharmaceutical company. The Company is focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology (LNC Platform). Its lead product candidate is MAT2203 (oral amphotericin B), a highly potent antifungal drug which, by virtue of LNC delivery, has been made oral, safe, and well-tolerated for prolonged administration in patients with life-threatening invasive fungal infections. MAT2203 is now positioned for a single, Phase III registration trial (the ORALTO trial) in support of a New Drug Application (NDA) for the treatment of invasive aspergillosis in patients with limited treatment options. It is expanding the utilization of the LNC Platform with small molecules and small oligonucleotides outside of infectious disease, targeting inflammation and oncology. It is also investigating a variety of LNC formulations of two small oligonucleotides designed to target inflammatory cytokines IL-17A and TNFα.