Matinas BioPharma Announces Pre-Screening of Patients to Determine Eligibility for Phase 2 ENHANCE-IT Study Against Vascepa®
BEDMINSTER, N.J., Sept. 25, 2019 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical stage biopharmaceutical company, today announced that it has commenced pre-screening patients to determine eligibility for ENHANCE-IT, its Phase 2 head-to-head pharmacodynamic (PD) study of MAT9001 against Vascepa in patients with elevated triglycerides (150-499 mg/dL).
“Our second head-to-head trial against Vascepa is an important milestone for our Company, and pre-screening patients for eligibility will facilitate rapid enrollment in the first quarter of 2020,” commented Jerome D. Jabbour, Chief Executive Officer of Matinas. “Topline data from this study, which we expect in the second half of 2020, will be another opportunity to distinguish MAT9001 from the market leading therapy in this emerging prescription omega-3 space.”
The “ENHANCE-IT trial (Pharmacodynamic effects of a free fatty acid formulation of omega-3 pentaenoic acids to enhance efficacy in adults with elevated triglycerides) will be led by Kevin C. Maki, Ph.D., President and Chief Scientist of Midwest Biomedical Research, and is expected to involve approximately six sites in the United States. “I am very excited about this clinical study,” stated Dr. Maki. “The world of prescription omega-3 therapies changed significantly after the results of REDUCE-IT, but there is still more to learn about this emerging class of medications regarding effects on cardiometabolic risk factors. ENHANCE-IT gives us an opportunity to confirm prior compelling data about the efficacy of MAT9001 compared to Vascepa.”
James J. Ferguson, M.D., Chief Medical Officer of Matinas, commenting on recent developments in omega-3 therapy and hypertriglyceridemia, said, “Momentum and excitement around the prescription omega-3 class continues to build as we enter a new era in the treatment of patients with elevated triglycerides (TGs). The recent Scientific Advisory document from the American Heart Association (AHA), which mentions MAT9001 favorably, the new European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) Lipid Guidelines and a new National Lipid Association (NLA) Position Statement all recommend omega-3 therapy for treating higher-risk patients with elevated TGs, not just those with severe hypertriglyceridemia (≥500 mg/dL). This additional head-to-head efficacy study in a greater number of patients over a longer period of time will allow us to further highlight MAT9001 and support its potential to benefit patients.”
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 with 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 Matinas’ proprietary lipid nano-crystal (“LNC”) platform 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.
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the Company's anticipated capital and liquidity needs, strategic focus and the future development of its product candidates, including MAT9001 and MAT2203, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company’s ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.
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Released September 25, 2019