Matinas BioPharma researchers have developed the investigational drug MAT2501 (encochleated amikacin) as a therapy for people with nontuberculous mycobacteria (NTM) infections.
NTMs are naturally occurring and found in water, soil, plants and animals. The bacteria can cause a number of serious, even life-threatening illnesses, including lung disease, skin and soft tissue diseases, and joint infections. The bacteria present an increased risk of illness for those whose immune systems are compromised.
MAT2501 is an orally administered, encochleated formulation of the broad spectrum IV-only aminoglycoside antibiotic agent amikacin. Amikacin currently is indicated for treatment of patients suffering from different types of chronic and acute bacterial infections.
Results from preclinical studies have shown MAT2501 to have bioavailability when used to treat lung and NTM infections. Further, it has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) and was also designated by the FDA as a Qualified Infectious Disease Product (QIDP) for the treatment of NTM infections.
“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-one studies this year,” Matinas President and CEO Roelof Rongen said. “MAT2501 has the potential to address significant unmet medical needs in chronic and acute bacterial infections, including NTM and other gram negative bacterial infections.”
As an orphan drug, MAT2501 will have a marketing exclusivity window of seven years, during which time no other company in the U.S. will receive FDA approvals for the product.
Researchers at Matinas will soon begin a phase-one clinical study of MAT2501 as a therapy for nontuberculous mycobacteria infections.
FDA grants orphan drug designation to nontuberculous mycobacteria therapy