Matinas BioPharma Files Investigational New Drug Application for Mycobacteria Drug

Matinas BioPharma Files Investigational New Drug Application for Mycobacteria Drug

Matinas BioPharma, a biopharmaceutical company developing therapeutics for serious and life-threatening infections using its proprietary encapsulation technology, recently announced the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its drug candidate MAT2501. The therapy is aimed at treating non-tuberculous mycobacterium (NTM) infections and NTM lung disease, and is of particular importance for patients with respiratory conditions as they are more susceptible to such infections, including patients with bronchiectasis and chronic obstructive pulmonary disease (COPD).

NTM are organisms that occur naturally in nature and can be found in water, soil, plants and animals. While the bacteria does not cause disease in most people, some individuals may develop serious conditions after inhaling it, such as pulmonary disease, skin and soft tissue disease, joint infections, and disseminated infections.

Individuals who are more susceptible to life-threatening airway and lung infection by NTM are usually the ones with pre-existing immune system or respiratory system defects, such as patients with bronchiectasis, a condition where chronic inflammation and/or infection leads the walls of bronchi to thicken and mucus to accumulate in the airways, generating a cycle of inflammation and infection.

According to the American Lung Association, NTM lung disease affects 50,000 to 90,000 people in the U.S. and it can require up to 2 years of treatment with antibiotics. Although some infections become chronic and have a significant impact on quality of life, deaths resulting directly from NTM infection are relatively rare. Resistance to antibiotics is, however, a serious concern.

MAT2501 is an orally administered formulation of the broad spectrum IV-only aminoglycoside antibiotic amikacin. It was developed under the proprietary technology of Matinas BioPharma, which uses a specific nanonoparticle delivery system with improve safety and tolerability profiles.

Roelof Rongen, President and Chief Executive Officer of Matinas BioPharma, commented on the lead candidate’s profile in a press release, “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.”

If approved by the FDA, the company plans to start a Phase 1 clinical trial with MAT2501 this year.

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