Matinas BioPharma Holdings, Inc., announced that its Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) is now open and the Company is authorized to initiate a Phase 1 clinical study for investigational drug, MAT2501 (encochleated amikacin), for the treatment of non-tuberculous mycobacterium (NTM) infections, its lead chronic indication.
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.
Matinas BioPharma’s MAT2501 encochleated formulation of amikacin is specifically designed to provide for the targeted delivery of this potent antibiotic while providing a significantly improved safety and tolerability profile. In preclinical studies MAT2501 demonstrated oral bioavailability and targeted delivery of amikacin directly to the site of infection in both pulmonary (lung) and disseminated NTM infections. The FDA designated MAT2501 as a Qualified Infectious Disease Product (QIDP) for the treatment of NTM infections in December of 2015.
Matinas BioPharma expects to commence the Phase 1 program of MAT2501 during the first half of 2016. The first planned Phase 1 trial is a placebo-controlled, single ascending dose study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of MAT2501 following oral administration in healthy adult subjects. After completion of this first study, the second study will be a placebo-controlled, multiple ascending dose study designed to evaluate the safety, tolerability and PK of MAT2501 at up to three different doses in healthy volunteers and is designed to establish a complete PK profile of MAT2501 including peak and trough levels in a multiple-dose regimen.
