Matinas BioPharma Initiates Dosing in Phase 1 Study of Potential First Oral Aminoglycoside Antibiotic Drug MAT2501
October 21, 2021 at 07:00 am EDT
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Matinas BioPharma Holdings, Inc. 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.
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.