December 16 2021 - 06:30AM
GlobeNewswire Inc.
Alert
Print
Share On Facebook
Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of critical therapeutics through its paradigm-changing lipid nanocrystal (LNC) platform delivery technology, today announced that the independent Data and Safety Monitoring Board (DSMB) of the EnACT trial (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial) has completed a prespecified review of the third cohort and unanimously recommended progression to the fourth and final cohort of patients. Enrollment in the next randomized EnACT cohort, with 40 active-treatment patients, is expected to begin early first quarter 2022.
“Unanimous DSMB approval to proceed to cohort four in the EnACT trial is a strong statement that MAT2203 continues to exceed the prespecified efficacy and safety thresholds assessed in the first two cohorts,” said Theresa Matkovits, Ph.D., Chief Development Officer of Matinas BioPharma. “We have made significant progress advancing MAT2203 through clinical development, and the fourth cohort of EnACT represents a meaningful opportunity to further validate an all-oral treatment regimen with amphotericin B, and position MAT2203 as a potential first-line treatment for cryptococcal meningitis. Ultimately, our goal is to develop MAT2203 to become the preferred therapeutic option for the treatment of most invasive fungal infections and provide physicians and patients with an effective, convenient and safe oral formulation of one of the most potent antifungal agents available.”
“Our team continues to be pleased with the performance of oral MAT2203 for the treatment of cryptococcal meningitis,” commented David Boulware, M.D., M.P.H, Professor of Medicine at the University of Minnesota and Principal Investigator for the trial. “Cohort 3 of the ENACT trial tested whether starting with an all-oral regimen of amphotericin and flucytosine would be possible. Participants received 5 days of oral combination therapy before a scheduled switch to intravenous amphotericin. In this cohort with 10 participants receiving MAT2203, the direct antifungal therapy activity measured in cerebrospinal fluid continued to be above our pre-defined target threshold for success. We are excited to begin the fourth cohort testing the all-oral regimen of MAT2203 in a larger number of patients beginning in early January.”
“The continued progression of EnACT and the impressive data generated to date in this highly vulnerable patient population are a clear demonstration of how our LNC platform can unlock the full therapeutic potential of life-saving medicines,” remarked Jerome D. Jabbour, Chief Executive Officer of Matinas. “We believe this is further validation of how our proprietary technology can be used to overcome significant drug delivery challenges and we remain excited by the interest shown in the application of the LNC platform beyond anti-infective therapies.”
About the EnACT Study
AI
