Matinas BioPharma Holdings Inc (NYSEAMERICAN:MTNB) announced Tuesday that it has commenced enrollment and started dosing patients in the ENHANCE-IT study of MAT9001 for the treatment of cardiovascular and metabolic conditions.
The company also said it expects to resume dosing patients in the EnACT study imminently, following the recent receipt of necessary governmental and regulatory approvals in Uganda. That study involves MAT2203, an oral formulation of amphotericin B to treat serious invasive fungal infections.
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,” said CEO Jerome Jabbour in a statement.
“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.”
In early June, the company said it resumed enrollment and began dosing patients in the ENHANCE-IT trial, a head-to-head study of MAT9001 versus the industry standard Vascepa. It expects to complete enrollment in August, with topline data available in the first quarter of 2021.
In late June, Matinas said it received approval from the Uganda National Drug Authority to restart the EnACT study. 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 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, the Bedminster, New Jersey-based biopharmaceutical company said.
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