Mar 31 2015
Matinas BioPharma Holdings, Inc. ("Matinas BioPharma" or the "Company"), a clinical-stage biopharmaceutical company focused on the development and commercialization of lipid-based prescription therapeutics for the treatment of infectious diseases and cardiovascular and metabolic conditions, today announced that upon a scheduled interim review, the study's Steering Committee recommended to stop enrollment early in its first-in-human study of investigational drug MAT9001 due to the study having enrolled a sufficient number of subjects (42 to date) necessary to demonstrate primary and secondary endpoints.
The Company's initial study is being conducted in Canada and is a two-way crossover pharmacokinetic and pharmacodynamic (PK/PD) study of MAT9001 versus an active prescription omega-3 medication comparator in subjects with high triglycerides (200-499 mg/dL).
The PK/PD clinical study was designed to evaluate approximately 50 subjects with high triglycerides to demonstrate better bioavailability and pharmacologic activity than the active comparator. The Steering Committee for this clinical study, comprised of Drs. Christie M. Ballantyne (Baylor College of Medicine), Kevin C. Maki (DePaul University) and William F. Keane (University of Minnesota, retired), recommended upon a planned interim review of the study data that the trial has adequate power and that no further subjects need to be enrolled to demonstrate the study's primary and secondary endpoints and that this interim review indicates that the study objectives have been met. The Company will complete the per-protocol treatment regimen for the enrolled subjects and expects to report top-line data from this PK/PD study in the second quarter of 2015.
"We are excited to be able to stop enrollment in our first human trial of MAT9001 with fewer than the originally planned number of subjects. We are looking forward to the completion of the study and the announcement of the top-line results in the near-term," commented Roelof Rongen, President and Chief Executive Officer of Matinas BioPharma.
MAT9001 is Matinas BioPharma's lead drug candidate in the cardiovascular/metabolic disease field, with an initial indication for the treatment of severe hypertriglyceridemia (TG≥500 mg/dL). MAT9001 is a uniquely engineered, prescription-only omega-3 fatty acid medication comprising docosapentaenoic acid (DPA) and other omega-3 fatty acids. Matinas BioPharma has specifically designed MAT9001 to provide a differentiated pharmacotherapy for the treatment of dyslipidemia.
About MAT9001
MAT9001 is a proprietary prescription-only omega-3 fatty acid-based composition, comprising docosa-pentaenoic acid (DPA) and other omega-3 fatty acids, which is under development for therapeutic applications with severe hypertriglyceridemia (TG>500 mg/dL) as the lead indication. Promising pre-clinical studies with DPA and MAT9001 indicate distinctive therapeutic response properties. In the fourth quarter of 2014, the Company filed an IND for MAT9001 with FDA and anticipates initiating a Phase 3 registration program pending two small studies and FDA agreement on the Phase 3 protocol. The Company believes that its development program and related clinical investigations may yield an improved therapeutic profile compared to existing therapies, based on MAT9001's differentiating mechanistic features associated with its unique composition.
Source: http://www.matinasbiopharma.com/