Matinas BioPharma Announces FDA Conditional Acceptance of LYPDISO™ as the Brand Name for MAT9001
January 04 2021 - 7:00AM
Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a
clinical-stage biopharmaceutical company focused on developing next
generation therapeutics to advance standards of care in areas of
significant unmet medical need, today announced the U.S. Food and
Drug Administration (FDA) has conditionally accepted LYPDISO™ as
the proposed brand name for MAT9001, the Company’s investigational
drug for treatment of cardiovascular and metabolic conditions. The
Company also announced that the United States Patent and Trademark
Office (USPTO) has issued a Notice of Allowance, approving the
Company’s application to register the LYPDISO brand name as a
federal trademark.
The name LYPDISO (pronounced “Lip-DEE-so”) was
developed in compliance with FDA’s Guidance for Industry,
Contents of a Complete Submission for the Evaluation of Proprietary
Names. Based on the development program, which included research
with physicians and pharmacists, as well as an international name
assessment, the Company believes LYPDISO is a proprietary name with
strong marketing potential that is also consistent with FDA’s goal
of preventing medication errors and potential harm to the public by
ensuring that only appropriate proprietary names are approved for
use. A request for proprietary name review and final approval for
LYPDISO will be included when Matinas submits a New Drug
Application (NDA) for MAT9001.
“We are pleased that the FDA has
conditionally accepted the name LYPDISO for our lead product
candidate and that we have also received a Notice of Allowance from
the USPTO toward registering this brand as a federal trademark,”
said Jerome D. Jabbour, Chief Executive Officer of Matinas.
“These meaningful steps align with our continued clinical progress,
as well as preparation for the commercialization of LYPDISO, if
approved. We eagerly await topline data from our ENHANCE-IT
head-to-head study vs. Vascepa® in the first quarter of 2021,
followed by the commencement of our Phase 3 program for LYPDISO in
the second half of 2021. We continue to believe that LYPDISO, if
approved, would provide an important and potentially best in class
product to help treat patients suffering from cardiovascular and
metabolic conditions.”
About Matinas BioPharma
Matinas BioPharma is a clinical-stage
biopharmaceutical company focused on developing next generation
therapeutics to advance standards of care for patients in areas of
significant unmet medical need. Company leadership has a deep
history and knowledge of drug development and is supported by a
world-class team of scientific advisors.
MAT9001, the Company’s lead product candidate
for the treatment of cardiovascular and metabolic conditions, is a
prescription-only omega-3 fatty acid-based composition, comprised
primarily of EPA and DPA, under development for
hypertriglyceridemia. MAT9001 is currently in a second head-to-head
comparative study against Vascepa® (ENHANCE-IT), with topline data
expected in the first quarter of 2021.
In addition, Matinas is developing a portfolio
of products based upon its proprietary lipid nanocrystal (LNC) drug
delivery platform, which can solve complex challenges relating to
the safe and effective delivery of potent medicines, making them
orally bioavailable, less toxic, and targeted to cells and
tissues.
MAT2203 is an oral, encochleated formulation of
the well-known, but highly toxic, antifungal medicine amphotericin
B, primarily used to treat serious invasive fungal infections.
MAT2203 is currently in a Phase 2 open-label, sequential cohort
study (EnACT) in HIV-infected patients with cryptococcal
meningitis. EnACT is currently enrolling patients in its second
cohort, with the next DSMB evaluation of safety and efficacy data
anticipated to occur in the middle of 2021.
MAT2501 is an oral, encochleated formulation of
the broad-spectrum aminoglycoside antibiotic medicine amikacin,
primarily used to treat chronic and acute bacterial infections. The
Company recently announced that it has been awarded up to $3.75
million from the Cystic Fibrosis Foundation (CFF) to support
development of MAT2501 toward an indication to treat nontuberculous
mycobacterial (NTM) lung disease, including infections in patients
with cystic fibrosis (CF).
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, including MAT9001, 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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