The ID Pipeline: FDA Activity From the Week of May 26, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of May 26, 2019.

Matinas BioPharma Holdings, Inc. Announces Efficacy Results of MAT2203 Preclinical Models for Cryptococcal Meningitis

On Tuesday, May 28, 2019, Matinas BioPharma Holdings, Inc. announced the publication of efficacy results from preclinical models evaluating MAT2203 in the American Society for Microbiology Journal, mBio.

MAT2203, for the treatment of cryptococcal meningitis, is an orally-administered formulation of amphotericin B (a broad spectrum fungicidal agent) utilizing Matinas’ proprietary lipid nano-crystal (“LNC”) delivery technology platform. In the study, scientists from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, demonstrated robust efficacy using MAT2203 in an animal model in infected mice with cryptococcal meningitis.

"In 1 experiment, MAT2203 was used alone after a 1-day infection incubation period and resulted in 80% survival of mice out to 60 days, which was equivalent to amphotericin B injection and superior to the untreated control group, which showed 100% mortality at Day 20," investigators reported. "In a second set of experiments, MAT2203 was administered orally for 28 days with flucytosine after a 3-day infection incubation period and resulted in up to 80% survival out to 200 days, comparable to that of injected amphotericin B administered with flucytosine. Treatment with the nano-crystal formulation also resulted in fungal clearance of cryptococcal fungal organisms comparable to that of injected amphotericin B and flucytosine. A fluorescent-tagged formulation of the nano-crystal formulation was also demonstrated to cross the blood brain barrier to deposit drug within brain tissue."

Read the full press release here.