Matinas BioPharma Holdings Inc (NYSE: MTNB) has announced positive data from the first two cohorts of the Phase 2 EnACT trial of MAT2203 (oral amphotericin B) for cryptococcal meningitis.
The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID).
In the second cohort, step-down therapy with MAT2203 achieved an effective clearance of fungal organisms was 0.38, significantly higher than the prespecified primary endpoint threshold of over 0.20. Cohort 2 evaluated stepdown to MAT2203 after two days of IV amphotericin.
There was no evidence of breakthrough or relapsed cryptococcal infections through 10 weeks. In Cohort 2, overall survival was 95% in 40 patients randomized to receiving MAT2203.
All 39 patients completing induction with MAT2203 achieved sterility, with no evidence of breakthrough or recurrent infections during the first ten weeks of antifungal treatment.
Enrollment in Cohort 3 of EnACT has commenced and is expected to complete by the end of 2021. Cohort 3 is the safety lead-in for Cohort 4, an all-oral MAT2203 treatment regimen.
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