Matinas BioPharma Initiates Dosing in Phase 1 Study of Potential First Oral Aminoglycoside Antibiotic Drug MAT2501
October 21 2021 - 07:00AM
GlobeNewswire Inc.
Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) platform delivery technology, today announced that it has dosed the first patient in a Phase 1 single ascending dose (SAD) pharmacokinetic study in healthy volunteers with MAT2501.
The Company expects to complete enrollment of the Phase 1 SAD study in the first quarter of 2022, with data anticipated during the second quarter of 2022. Pending successful completion of the Phase 1 SAD study, the Company expects to start a Phase 2 program in patients with nontuberculous mycobacterial (NTM) infections by the first quarter of 2023, following required longer-term preclinical toxicology studies to be conducted during 2022.
MAT2501 is being developed to potentially become the first oral aminoglycoside, with the application of Matinas’ proprietary LNC platform technology to the broad-spectrum antibiotic drug amikacin. Amikacin is a highly potent antibiotic used to treat chronic and acute bacterial infections, including problematic gram-negative infections.
Currently, amikacin’s use (IV or inhalation) is severely limited due to associated major side effects including nephrotoxicity and ototoxicity (hearing loss and potentially permanent impairment of balance), as well as inhalation complications with certain approved therapies.
“Following the robust data from MAT2203 in the EnACT trial announced in September 2021, MAT2501 now becomes our second clinical stage product candidate demonstrating the benefits of our LNC platform delivery technology in treating infectious diseases.
Our goal with MAT2501 is to develop the first oral aminoglycoside, which could transform the use of this important class of drugs,” stated Jerome D. Jabbour, Chief Executive Officer of Matinas. “At its core, our LNC platform facilitates intracellular delivery. We believe that MAT2501’s ability to orally, effectively, efficiently and safely deliver therapeutic levels of amikacin that specifically target the lung, without use-limiting toxicity, clearly distinguishes it from other available therapies for the treatment of NTM infections.
Furthermore, we believe that the ultimate applicability of MAT2501 will not be limited to the treatment of pulmonary infections, and we expect to evaluate its use in other, more acute bacterial infections, such as gram-negative infections, where the unmet medical need is significant and unfortunately growing due to a lack of effective therapies.”
This Phase 1 study is a double-blind, placebo-controlled, SAD study designed primarily to evaluate the safety, tolerability and pharmacokinetics of single ascending oral doses of MAT2501 in healthy adult subjects. Secondary objectives include the assessment of the effect of food on the pharmacokinetics of amikacin following a single oral dose of MAT2501.
Development of MAT2501 has been supported by a $4.2 million Therapeutics Development Award from the Cystic Fibrosis Foundation.
The U.S. Food and Drug Administration (FDA) has designated MAT2501 as a Qualified Infectious Disease Product (QIDP) and as an Orphan Drug for the treatment of NTM. If MAT2501 is ultimately approved by the FDA, the seven-year period of marketing exclusivity from orphan designation combined with the additional five years of marketing exclusivity provided by the QIDP designation, would provide for a potential total of 12 years of marketing exclusivity.
