Matinas BioPharma Granted US Orphan Drug Designation for MAT2501 for Treatment of Non-Tuberculous Mycobacteria Infections

Matinas BioPharma Holdings, Inc. (OTCQB:MTNB) announced that its investigational drug MAT2501 (encochleated amikacin) was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of non-tuberculous mycobacteria (NTM) infections, its lead chronic indication.
According to the news:

MAT2501, an orally-administered, encochleated formulation of the broad spectrum IV-only aminoglycoside antibiotic agent amikacin, utilizes the Company’s proprietary, lipid-crystal, nanoparticle delivery technology. Amikacin is currently used to treat different types of chronic and acute bacterial infections, including NTM infections and various multidrug-resistant gram negative bacterial infections. IV-administered amikacin is associated with major side effects including nephrotoxicity and ototoxicity (permanent loss of hearing) with long-term use.

Roelof Rongen, President and Chief Executive Officer commented:

The orphan drug approval for MAT2501 is a noteworthy achievement in our regulatory strategy to advance this potentially game-changing oral aminoglycoside through the clinical development process as we progress into Phase 1 studies this year. MAT2501 has the potential to address significant unmet medical needs in chronic and acute bacterial infections, including NTM and other gram negative bacterial infections.

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