Matinas BioPharma of Bedminster, N.J., filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the development of its antibacterial drug MAT2501 for the treatment of various types of multidrug-resistant bacteria, such as non-tubercular mycobacterial infections (NTM).
NTM are environmental mycobacteria causing a number of serious and life-threatening diseases, particularly in the lungs. In the U.S., 50,000 to 90,000 people suffer from NTM pulmonary disease, and these numbers are on the rise.
NTM infections in the lungs are likely to occur in patients with prior lung disease, particularly those suffering from chronic obstructive pulmonary disease (COPD), pneumoconiosis, bronchiectasis, previous tuberculosis, and cystic fibrosis. Consequently, patients with NTM lung disease often share similar symptoms with those of the underlying disease, including cough, chest discomfort, fatigue, fever, weight loss, and shortness of breath.
Treatment for NTM is difficult because these bacteria usually develop a resistance to many common types of antibiotics. As a result, patients infected with NTM are often prescribed several types of antibiotics at the same time, which may result in severe side effects. In addition, some antibiotics such as amikacin are administrated intravenously, intramuscular or through nebulization routes, which may cause further significant risk of poisoning and toxicity.
MAT2501, in contrast, can be administered orally, and could be safer to use, especially in patients with a severe compromised immune system. MAT2501 uses lipid-crystal, nanoparticle delivery technology that provides a targeted delivery of the drug in a tolerable, and less toxic way.
“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,” Roelof Rongen, president and CEO of Matinas BioPharma, said in a press release. “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.”
Upon approval of the IND application, Matinas BioPharma intends to launch a Phase 1 clinical trial of MAT2501 in 2016.
“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,” said Jerome D. Jabbour, company co-founder and the chief business officer.