Matinas BioPharma Holdings Inc (NYSEAMERICAN:MTNB) (FRA:6LJ), a clinical-stage biopharmaceutical company, announced Monday that the independent Data and Safety Monitoring Board (DSMB) of its EnACT study has completed a review of the study’s first cohort of patients and unanimously recommended progression to the next cohort.
Enrollment in the next randomized EnACT group, which will include 40 active-treatment patients, is expected to begin shortly, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the middle of 2021, the company said.
The EnACT (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial) Phase 2 study is examining the impact of Matinas’ drug MAT2203 on patients with cryptococcal meningitis, an infection of the brain and spinal column.
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“Cohort progression in the EnACT study is an important milestone for the development of MAT2203,” Chief Development Officer Theresa Matkovits said in a statement. “The unanimous DSMB recommendation is very encouraging and supports our views of the overall safety and efficacy profile of MAT2203. We look forward to promptly commencing enrollment in the next cohort of EnACT, which will provide more robust evidence about the efficacy and safety of MAT2203.”
EnACT is being financially supported by the National Institutes of Health (NIH), the company said, and is evaluating the safety, tolerability and efficacy of MAT2203 in about 100 HIV-infected patients with cryptococcal meningitis.
“Cryptococcal meningitis is a deadly fungal disease which results in severe, invasive infections of the brain and imposes a major burden and high mortality in vulnerable immunocompromised patients around the world,” Matkovits said. “We believe that an oral amphotericin B formulation, with targeted drug delivery directly to infected tissues throughout the body, substantially reduces the risk of toxicity without sacrificing efficacy. Based on this profile, MAT2203 has the potential to provide an invaluable solution for physicians and patients and ultimately advance the standard of care for the treatment of severe, invasive fungal infections.”
MAT2203 relies on the company’s liquid nanocrystal (LNC) platform delivery technology to orally deliver the traditionally IV-only fungicidal drug, amphotericin B.
“Cohort progression in EnACT is also another step forward in further validating the potential of our LNC platform delivery technology,” Chief Scientific Officer Raphael Mannino said. “DSMB approval to proceed to the second patient cohort is a promising signal that MAT2203 is orally bioavailable and successfully crosses the blood-brain barrier. Continued success in EnACT will further demonstrate that oral, LNC delivery of therapeutic agents to the brain is possible, and we remain optimistic that our LNC platform could become an important alternative to other traditional, but problematic, delivery vehicles such as lipid nanoparticles or viral vectors, across a wide variety of therapeutic applications.”
The induction period for all patients in each cohort of EnACT is 14 days, the company said, followed by an additional four weeks of treatment with MAT2203 for all patients during a maintenance period. In total, the trial includes four cohorts of patients, with each cohort increasing the treatment duration of MAT2203 versus IV amphotericin B.
The primary efficacy endpoint will be measured at Day 14, the last day of the induction period, and will include a measure of reduction in fungal count in the cerebral spinal fluid. A control arm, which includes standard of care IV amphotericin B, is included with each cohort, the company noted.
The US Food and Drug Administration (FDA) previously designated MAT2203 as a Qualified Infectious Disease Product (QIDP) with Fast Track status for four indications, namely the prevention of invasive fungal infections due to immunosuppressive therapy, in addition to the treatment of invasive candidiasis, invasive aspergillus and cryptococcal meningitis.
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