FDA Approves IND Application for Multidrug-Resistant Bacterial Infections

FDA Approves IND Application for Multidrug-Resistant Bacterial Infections

Matinas BioPharma Holdings recently announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application, and the company can now begin a Phase 1 clinical trial to test the antibacterial drug MAT2501 (encochleated amikacin) in the treatment of infections with the multidrug-resistant bacteria called non-tuberculous mycobacterium (NTM).

In the United States alone, 50,000 to 90,000 people are infected with NTM, a potential life-threatening bacteria found in soil, water, plants and animals. This bacterium can cause a number of serious diseases, particularly lung infections in older or immunocompromised individuals who become infected by inhaling the bacteria in contaminated environments.

If people with healthy lungs become infected with NTM, it is unlikely to result in inflammation or disease. But if the infection occurs in patients with prior lung diseases such as chronic obstructive pulmonary disease (COPD), pneumoconiosis, bronchiectasis, tuberculosis, cystic fibrosis, and emphysema, it results in progressive inflammation of the lungs, which are already damaged from the previous lung disorders.

Patients with NTM lung infection can experience symptoms such as chest discomfort, coughing, fatigue, fever, and weight loss, which require a continuous treatment. But the treatment can be challenging because NTM bacteria often develop resistance to antibiotics. As a result, physicians often opt to prescribe a combination treatment based on several antibiotics. This, in turn, may result in severe adverse effects or risk of poisoning or toxicity, particularly if the antibiotics are administrated via intravenous (IV) routes, like IV-administered amikacin.

MAT2501 is an orally administered drug (encochleated amikacin) based on lipid-crystal, nanoparticle delivery technology that facilitates its targeted delivery combined with improved safety and tolerability. The latter was demonstrated in preclinical studies performed on both pulmonary and disseminated NTM infections. In December 2015, the FDA classified MAT2501 as a Qualified Infectious Disease Product (QIDP) for the treatment of NTM infections.

“The encouraging preclinical data demonstrating MAT2501’s oral bioavailability and its targeted delivery of amikacin directly to the site of infection in NTM infections gives us confidence as we prepare for our upcoming Phase 1 study,” Roelof Rongen, president and CEO of Matinas BioPharma, said in a press release. “Importantly, we believe our oral encochleated formulation of MAT2501 has the potential to address the many shortcomings that currently exist in the treatment of both chronic and acute bacterial infections with IV administration of amikacin, including major side effects associated with toxicity.”

The Phase 1 trial will be a placebo-controlled study, where small doses of MAT2501 will be orally administrated to healthy adults in order to assess the drug’s safety, tolerability, and pharmacokinetics (PK). Afterwards, increasing doses of the drug will be tested in healthy volunteers to establish a full profile of MAT2501.

“The achievement of this regulatory milestone underscores the significance of MAT2501’s robust preclinical data package. We look forward to promptly advancing this program into clinical development,” said Jerome D. Jabbour, the company’s co-founder and chief business officer. “We believe MAT2501 has the potential to be the first orally-available aminoglycoside, representing a disruptive, game-changing shift in the treatment paradigm for both chronic and acute bacterial infections, including both NTM and gram-negative bacterial infections, and an important solution for physicians and patients.”

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