Benzinga | Oct 19, 2020 06:33AM EDT

Matinas BioPharma Announces Unanimous DSMB Approval to Progress Into Second Cohort of Patients In The EnACT Study of MAT2203 For The Treatment of Cryptococcal Meningitis

Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today announced that the independent Data and Safety Monitoring Board (DSMB) of the EnACT study (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial) has completed a pre-specified review of the first cohort and unanimously recommended progression to the second cohort of patients. Enrollment in this next randomized EnACT cohort, with 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.

"Cohort progression in the EnACT study is an important milestone for the development of MAT2203," commented Theresa Matkovits, Ph.D., Chief Development Officer of Matinas BioPharma. "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."

"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," continued Dr. Matkovits. "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."

"Overall, we are pleased with the safety and performance of MAT2203 following 5 days of initial intravenous (IV) amphotericin B. In the next stage of the trial, we will continue to test MAT2203 following only 2 days of initial IV amphotericin B, and we would be very pleased to see similar performance," commented David Boulware, M.D., M.P.H, Professor of Medicine at the University of Minnesota and Principal Investigator for the trial.

"Cohort progression in EnACT is also another step forward in further validating the potential of our LNC platform delivery technology," commented Raphael J. Mannino, Ph.D., Chief Scientific Officer of Matinas BioPharma. "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."

EnACT is a Phase 2 prospective, randomized, open-label, sequential cohort study, financially supported by the National Institutes of Health (NIH), evaluating the safety, tolerability and efficacy of MAT2203 in approximately 100 HIV-infected patients with cryptococcal meningitis. MAT2203 utilizes the Company's LNC platform delivery technology to orally deliver the traditionally IV-only fungicidal drug, amphotericin B.

The induction period for all patients in each cohort of EnACT is 14 days, followed by an additional 4 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 vs. IV amphotericin B. The first cohort received IV amphotericin B for the first five days of the induction period, followed by nine days of oral administration of MAT2203. The second cohort of 40 actively treated patients will receive IV amphotericin B for the first two days of the induction period, followed by twelve days of oral administration of MAT2203. 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. An independent DSMB oversees the safety of the study and reviews all data from each cohort for safety and efficacy and makes a recommendation to proceed to the next cohort of patients.

As previously reported, the U.S. Food and Drug Administration (FDA) has designated MAT2203 as a Qualified Infectious Disease Product (QIDP) with Fast Track status for four indications, specifically, the prevention of invasive fungal infections due to immunosuppressive therapy, and the treatment of invasive candidiasis, invasive aspergillus and cryptococcal meningitis. In addition, the FDA has granted orphan drug designation to MAT2203 for the treatment of cryptococcosis.