Matinas BioPharma Announces Collaboration with the National Institute of Allergy and Infectious Diseases to Evaluate Oral For...
December 07 2020 - 6:35AM
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 that they plan to
collaborate with the National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes of Health (NIH),
to test oral formulations of remdesivir in preclinical models.
Remdesivir is owned by Gilead Sciences, Inc. (Nasdaq: GILD) and the
lipid nanocrystal (LNC) platform is owned by Matinas. Any product
generated as a part of efforts by Matinas and NIAID would require a
license from Gilead for the use of remdesivir and a license from
Matinas for the use of the LNC formulation.
One or more formulations of remdesivir will be
developed using Matinas’ Lipid Nanocrystal (LNC) platform delivery
technology, which enables the development of a wide range of
difficult-to-deliver molecules. Matinas plans to utilize NIAID’s
suite of preclinical services to carry out antiviral testing with
selected formulations. Gilead will provide remdesivir and work with
Matinas to evaluate the data generated from the planned series of
preclinical studies.
“We believe that our LNC technology may be
applied to remdesivir to allow for the potential for oral
administration of this important drug in the fight against
COVID-19,” commented Jerome D. Jabbour, Chief Executive Officer of
Matinas.
Matinas’ LNC platform delivery technology offers
an oral intracellular drug delivery solution with potential
advantages over other delivery technologies across a broad range of
therapeutics. The Company has demonstrated in preclinical animal
models the ability to formulate and deliver a wide variety of
molecules and drugs (including oligonucleotides, peptides,
proteins, vaccines, and small molecules) which, (a) require
delivery technology to improve the stability of molecules inside
and outside of the body; (b) could benefit from efficient delivery
and cellular uptake by target cells; (c) are currently only
available in IV formulations or (d) otherwise experience
significant toxicity-related adverse events.
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 preparing to enroll 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).
Gilead is a trademark of Gilead Sciences, Inc.,
or its related companies.
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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