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news.Matinas BioPharma has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its lead antibacterial development candidate, MAT2501.
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Matinas BioPharma president and CEO Roelof Rongen said: "In preclinical studies, MAT2501 was shown to have oral bioavailability and provide targeted delivery of the powerful antibiotic, amikacin, directly to the site of infection in both disseminated non-tuberculous mycobacterium (NTM) infections as well as in NTM-lung disease.
"We believe MAT2501 has the potential to address significant unmet medical needs in the treatment of infectious diseases, especially in chronic bacterial infections such as NTM, as well as numerous gram negative bacterial infections where antibiotic resistance has rendered the majority of standard therapies obsolete."
MAT2501 is an orally-administered, encochleated formulation of the broad spectrum IV-only aminoglycoside antibiotic agent amikacin, which is currently used to treat different types of chronic and acute bacterial infections, including NTM infections and various multidrug-resistant gram negative bacterial infections.
MAT2501 utilizes the Company’s proprietary, lipid-crystal, nanoparticle delivery technology, which is specifically designed to provide for the targeted delivery of potent therapeutics while providing a significantly improved safety and tolerability profile. Nephrotoxicity and ototoxicity (permanent loss of hearing) are some of the major side effects associated with long-term use of amikacin.
Matinas BioPharma co-founder and chief business officer Jerome Jabbour said: "The completion of our planned IND filing for MAT2501 before the end of 2015 represents a significant achievement for our team and the first of many anticipated regulatory and clinical milestones that we expect to drive value into our development programs over the course of 2016."
Pending FDA clearance of the IND, the Company plans to initiate a Phase 1 clinical trial with MAT2501 in 2016.
Matinas BioPharma also recently announced that the FDA designated MAT2501 as a Qualified Infectious Disease Product (QIDP) for the treatment of NTM infections.