– MAT9001 is a uniquely engineered omega-3 fatty acid comprising docosapentaenoic acid (DPA) for the treatment of hypertriglyceridemia –
– MAT9001 demonstrated superiority versus Amarin’s Vascepa® on bioavailability, triglyceride reduction and other lipid endpoints –
BEDMINSTER, N.J., Sept. 12, 2017 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (“Matinas BioPharma” or the “Company”) (NYSE MKT:MTNB), a clinical-stage biopharmaceutical company focused on developing innovative anti-infectives for orphan indications, today announced that it has retained JSB Partners, a global life sciences advisor, to identify a partner for the Company’s legacy cardiovascular product candidate, MAT9001.
MAT9001 is a uniquely engineered, prescription-only omega-3 fatty acid medication comprising DPA and is specifically designed to provide a differentiated pharmacotherapy for the treatment of dyslipidemia.
“We believe that MAT9001, and its proprietary gel cap delivery system, has the potential to be a best-in-class product for the treatment of dyslipidemia. Although we continue to focus our development efforts and resources on our disruptive cochleate delivery platform technology given the vast opportunity presented by our MAT2203 and MAT2501 infectious disease products, we believe that it is the ideal time to formalize our efforts to realize the potentially significant value that MAT9001 possesses, particularly in light of the forthcoming data from Amarin’s REDUCE-IT outcomes trial due in 2018,” remarked Jerome D. Jabbour, President and co-Founder of Matinas BioPharma. “We are thrilled to be working with JSB Partners as we evaluate the strategic opportunities available for MAT9001. JSB Partners’ experience and track record speaks for itself and we believe they are well positioned to assist us in maximizing MAT9001’s value on a domestic and international basis.”
In Matinas BioPharma’s head-to-head comparative pharmacokinetic and pharmacodynamic study versus Amarin’s Vascepa® (icosapent ethyl), MAT9001 met all of its primary and secondary endpoints and demonstrated statistically significant superiority over Vascepa for omega-3 bioavailability (baseline adjusted AUC and Cmax, approximately 6-fold higher with MAT9001 on day 14, with very high statistical significance) and triglyceride reduction (median TG-reduction from baseline: -33.2% for MAT9001 versus -10.5% for Vascepa; p<0.0001). MAT9001 also demonstrated a statistically significantly greater reduction in total-cholesterol, VLDL-cholesterol and non-HDL-cholesterol for MAT9001 versus Vascepa. In addition, MAT9001 demonstrated a statistically significant reduction in PCSK9 versus Vascepa, which did not decrease PCSK9 levels.
The comparator study was conducted in 42 patients with high triglyceride levels. Study subjects had fasting TG levels of 200 to 400 mg/dL without lipid altering therapy, or fasting TG levels of 200 to 350 mg/dL if they were on a stable-dose statin monotherapy. Pre-treatment median values for lipids, triglycerides, apolipoproteins and PCSK9 levels were measured. Patients were randomized and put on MAT9001 or Vascepa for 14 days, then washed out over five weeks, and then crossed over to Vascepa or MAT9001 for 14 days. Forty patients completed the trial.
Wolfgang Stoiber, MD, MBA, of JSB Partners, stated, "We are excited to be working with Matinas BioPharma on establishing potential development and/or marketing partnerships for MAT9001. We are impressed with the profile of this potential best-in-class product and by the data generated to date in humans. Over the last 18 years we have helped numerous bio-pharmaceutical companies develop partnerships and joint ventures for their respected products and look forward to the possibility of completing a transaction on MAT9001."
Vascepa is indicated for use with a lipid-lowering diet to reduce very high triglycerides in adult patients and is a trademark of Amarin Pharmaceuticals Ireland Ltd.
MAT9001 is a proprietary prescription-only omega-3 fatty acid-based composition, comprising docosapentaenoic 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. 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.
About Matinas BioPharma
Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing innovative anti-infectives for orphan indications. The Company's proprietary, disruptive technology utilizes lipid-crystal nano-particle cochleates to nano-encapsulate existing drugs, making them safer, more tolerable, less toxic and orally bioavailable.
The Company's lead anti-infective product candidates, MAT2203 and MAT2501, position Matinas BioPharma to become a leader in the safe and effective delivery of anti-infective therapies utilizing its proprietary lipid-crystal nano-particle cochleate formulation technology. For more information, please visit www.matinasbiopharma.com and connect with the Company on Twitter, LinkedIn, Facebook, and Google+.
Forward Looking Statements: 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 strategic focus and the future development of its product candidates 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, the Company’s ability to identify and pursue business development or partnership opportunities for its products on favorable terms, if at all, 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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