Matinas BioPharma (MTNB) Resumes Enrollment in the ENHANCE-IT and EnACT Clinical Trials

Matinas BioPharma Holdings, Inc. (NYSE: MTNB), today announced that it has commenced enrollment and started dosing patients in the ENHANCE-IT study and that it expects to resume dosing patients in the EnACT study imminently, following the recent receipt of necessary governmental and regulatory approvals in Uganda. Both studies had temporarily paused enrollment in March due to the COVID-19 pandemic.

“I am extremely pleased with our execution and progress during a period of significant uncertainty, given all of the ramifications of the ongoing COVID-19 pandemic. Resuming enrollment in both ENHANCE-IT and EnACT were critical milestones for our Company and position us to deliver potentially clinically meaningful Phase 2 data for our lead products relatively quickly,” stated Jerome D. Jabbour, Chief Executive Officer of Matinas. “We believe we have taken the appropriate steps to ensure the safety of clinical trial participants and caregivers and we remain grateful for their commitment to our important clinical work. We look forward to completing these studies within our previously communicated timelines and believe each study represents a significant value-creating opportunity.”

ENHANCE-IT Study Update

• In early June, the Company resumed enrollment and began dosing patients in the ENHANCE-IT (Pharmacodynamic Effects of a Free-fatty Acid Formulation of Omega-3 Pentaenoic Acids to ENHANCE Efficacy in Adults with Hypertriglyceridemia) trial, a head-to-head study of MAT9001 vs. Vascepa.
• The Company expects to complete enrollment in August of 2020, with topline data available in the first quarter of 2021.

EnACT Study Update

• In late June, Matinas received approval from the Uganda National Drug Authority to restart the EnACT study (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial) and is preparing to begin dosing patients imminently. The first cohort of patients is expected to fully enroll by early September based upon projections from Dr. David Boulware, the Principal Investigator for the EnACT trial.
• Evaluation of data from the first cohort of patients by the independent Data and Safety Monitoring Board and anticipated progression from the first patient cohort to the second patient cohort is expected during the fourth quarter of 2020.

About Matinas BioPharma

Matinas BioPharma is a clinical-stage biopharmaceutical company focused on development of its lead product candidate, MAT9001, for the treatment of cardiovascular and metabolic conditions. MAT9001 is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia, that was specifically designed to overcome the shortcomings seen from other agents in the omega-3 class. Company leadership has a deep history and knowledge of cardiovascular drug development and is supported by a world-class team of scientific advisors.

In addition, the Company is developing MAT2203, an oral, encochleated formulation of amphotericin B, to treat serious invasive fungal infections. The drug is based on the Company’s proprietary lipid nano-crystal (LNC) platform delivery technology, which can help solve complex challenges relating to the safe and effective delivery of potent medicines, potentially making them more targeted, less toxic and orally bioavailable.

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