Matinas BioPharma Announces Pre-Screening of Patients to Determine Eligibility for Phase 2 ENHANCE-IT Study Against Vascepa®...
September 25 2019 - 7:00AM
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.
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 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.
Investor and Media Contacts |
|
Peter VozzoWestwicke443-213-0505peter.vozzo@westwicke.com |
Ian CooneyDirector – Investor Relations &
Corporate DevelopmentMatinas Biopharma, Inc.(415)
722-4563icooney@matinasbiopharma.com
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