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 it has been
awarded up to $3.75 million from the Cystic Fibrosis Foundation
(CFF). The award will support preclinical development of MAT2501,
Matinas’ lipid nano-crystal (LNC) oral formulation of the
broad-spectrum aminoglycoside amikacin, toward an indication to
treat nontuberculous mycobacterial (NTM) lung disease, including
infections in patients with cystic fibrosis (CF).
“We are grateful to the Cystic Fibrosis Foundation for their
support in accelerating the development of MAT2501 as a potential
best in class treatment for NTM lung disease. These are
debilitating, potentially life-threatening, and increasingly
prevalent pulmonary infections, especially in patients with cystic
fibrosis,” commented Jerome D. Jabbour, Chief Executive Officer of
Matinas. “We believe that an orally bioavailable amikacin, which
takes advantage of our LNC delivery platform, would be the first
oral aminoglycoside and would represent a significant improvement
over currently available therapy. Furthermore, an oral, well
tolerated, and targeted aminoglycoside would also potentially be of
considerable value in treating other acute bacterial infections,
especially gram-negative infections, where oral options are very
limited and drug resistance is an increasing challenge. We look
forward to continuing to work with the CF Foundation on realizing
the potential of our LNC delivery platform.”
The CFF award will allow Matinas to rapidly advance the
development of MAT2501 and will support preclinical in vitro and in
vivo studies, along with several of the toxicology studies
necessary to progress MAT2501 into Phase 2. Pending a successful
preclinical program, the CFF has indicated to Matinas a willingness
to consider a request for further monetary support for the
continuation of clinical studies, including dose determination and
Phase 2 efficacy studies in CF patients suffering from NTM lung
disease.
MAT2501 has been designated as a Qualified Infectious Disease
Product (QIDP) and as an Orphan Drug for the treatment of NTM by
the U.S. Food and Drug Administration (FDA). Orphan Drug
designation of MAT2501 provides for a seven-year marketing
exclusivity period against competition in the United States upon
FDA approval, as well as other incentives and exemptions, including
waiver of Prescription Drug User Fee Act (PDUFA) filing fees and
tax credits for the cost of the clinical research. If MAT2501 is
ultimately approved by the FDA, the seven-year period of marketing
exclusivity from orphan designation combined with the additional
five years of marketing exclusivity provided by the QIDP
designation, provides for a potential total of 12 years of
marketing exclusivity.
About
NTM Lung
Disease
NTM lung disease is a chronic, debilitating
condition arising from an NTM infection in the lungs and is
associated with significant patient morbidity and mortality. The
signs and symptoms of NTM lung disease often overlap with the
underlying lung conditions that increase risk for NTM, like cystic
fibrosis, bronchiectasis, COPD, and asthma. The most common
pathogens for NTM infections in the United States are Mycobacterium
avium complex (MAC), which accounts for more than 80% of all NTM
infections in the U.S. Patients with NTM lung infections frequently
require lengthy hospital stays and prolonged courses of antibiotics
to manage their disease.
The prevalence of human disease attributable to
NTM has increased over the past two decades and is now growing at
more than 8% per year and is even more prevalent than tuberculosis
in the U.S. In 2018, it was estimated that between 75,000 and
100,000 patients were diagnosed with NTM lung disease in the U.S.
alone.
About
MAT2501
MAT2501 is an oral, encochleated formulation of
the broad-spectrum aminoglycoside antibiotic agent amikacin, which
utilizes the Company’s proprietary LNC platform to achieve oral
bioavailability, limit toxicity and enable targeted delivery to
sites of infection. Currently, amikacin can only be delivered
parenterally or through inhalation and is used to treat a variety
of chronic and acute bacterial infections, including both NTM
infections and various multidrug-resistant gram-negative bacterial
infections. IV and inhaled amikacin, however, are associated with
major side effects including nephrotoxicity and ototoxicity
(permanent loss of hearing) with long-term use. Matinas
believes that MAT2501’s ability to orally deliver high levels of
amikacin directly to the lung and without use-limiting toxicity,
distinguishes it from all available therapies and could provide an
important solution for patients and physicians.
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 nano-crystal (LNC)
drug delivery platform, which can solve complex challenges relating
to the safe and effective delivery of potent medicines, making them
more targeted, less toxic and orally bioavailable.
MAT2203, the Company’s lead product candidate
utilizing its LNC platform, is an oral, encochleated formulation of
the well-known, but highly toxic, antifungal medicine amphotericin
B, 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 will
promptly begin enrolling patients in its second cohort, with the
next DSMB evaluation of safety and efficacy data anticipated to
occur in the middle of 2021.
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 MAT2203 and
MAT2501, 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
ContactsPeter
VozzoWestwicke443-213-0505peter.vozzo@westwicke.com
Ian CooneyDirector – Investor Relations &
Corporate DevelopmentMatinas Biopharma, Inc.(415)
722-4563icooney@matinasbiopharma.com
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