Clinical stage biotech Matinas BioPharma Holdings ( NYSE: MTNB ) announced Friday that its experimental therapy MAT2203 met the primary endpoint for a group of patients in a Phase 2 trial for cryptococcal meningitis.
MAT2203 is an oral formulation of amphotericin B based on MTNB's lipid nanocrystal (LNC) platform technology.
The EnACT study, supported by the National Institutes of Health (NIH) National Institute of Neurological Disorders and Stroke (NINDS) included a total of four cohorts.
The data readout was based on Cohort 4, which involved 40 in the MAT2203 treatment arm and 40 in the standard of care (SOC) controls.
According to the company, the interim data from the cohort indicated that the experimental therapy met the study's main goal based on the rate of yeast clearance in the cerebrospinal fluid.
Cohort 4 also indicated that the overall survival, a key secondary endpoint of EnACT, reached 95% at two weeks to stand at 90%, with final follow-up in progress.
In terms of safety, 42% of patients who received MAT2203 reported Grade ?3 clinical adverse events compared to 59% in the SOC group. MAT2203 was also linked to a lower incidence of adverse events related to kidney function and anemia.
"These interim results potentially open other opportunities to explore this oral amphotericin therapy for other difficult to treat or resistant invasive fungal infections," said David R. Boulware, Professor of Medicine, University of Minnesota Medical School. Boulware served as the co-principal investigator of the EnACT study.
Matinas BioPharma ( MTNB ) plans to start a Phase 3 registration trial for MAT2203 in Q1 2023, targeting patients with cryptococcal meningitis.
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Matinas BioPharma says mid-stage study for meningitis therapy met main goal