Matinas BioPharma Holdings, Inc. (NYSE MKT:MTNB), a clinical-stage
biopharmaceutical company focused on developing innovative
anti-infectives for orphan indications, today announced positive
efficacy results from the study of MAT2501 in an in vitro
preclinical model of Mycobacterium abscessus. This study was
conducted in collaboration between Matinas BioPharma and Colorado
State University (CSU), supported, in part, through a contract from
the Division of Microbiology and Infectious Diseases, NIAID,
National Institutes of Health.
MAT2501 is Matinas BioPharma’s
orally-administered, encochleated formulation of the broad spectrum
IV-only aminoglycoside antibiotic agent amikacin, which utilizes
the Company’s proprietary lipid-crystal nano-particle delivery
technology. Amikacin is currently used in clinical practice to
treat different types of chronic and acute bacterial infections,
including non-tuberculous mycobacterium (NTM) infections and
various multidrug-resistant gram negative bacterial infections. IV
administered amikacin is associated with major side effects
including nephrotoxicity and ototoxicity (permanent loss of
hearing).
In previous preclinical work, MAT2501
demonstrated efficacy in cell-based assays and studies in animals
with both lung and disseminated Mycobacterium avium infections, the
most prevalent organism causing NTM infections in humans. MAT2501
is currently being tested in Phase 1 healthy volunteer studies.
In this in vitro preclinical model developed by
CSU, bone marrow derived macrophage (BMDM) were isolated from SCID
mice, an immunodeficient mouse strain, and placed into culture.
Once isolated, the BMDM were infected with Mycobacterium abscessus
and, once infection was established, were then treated with various
escalating doses of MAT2501. The results of this study showed that
increasing doses of MAT2501 resulted in increased reduction of the
Mycobacterium abscessus bacteria.
“These results are encouraging because lung
infections with Mycobacterium abscessus, a species of multi-drug
resistant nontuberculous mycobacteria, are emerging as an important
global threat to individuals suffering from immunosuppression or
with chronic disease, such as cystic fibrosis. Confirming these
results using in vivo models will be an important step in the
development of MAT2501 for the treatment of Mycobacterium
abscessus,” stated Diane Ordway, Ph.D., Assistant Professor at
Colorado State University, Mycobacteria Research Laboratory, who
led the in vitro work.
The positive results showing the efficacy of
MAT2501 against Mycobacterium abscessus in this in vitro assay
provide the required proof-of-concept (POC) validation needed to
advance MAT2501 into in vivo, preclinical animal studies. Planning
and preparation for these preclinical POC animal studies are in
progress.
The research presented in this publication was
supported by the National Institute of Allergy and Infectious
Diseases (preclinical services contract HHSN272201000009I).
Roelof Rongen, Co-founder and Chief Executive
Officer of the Company, stated, “These results represent an
important step forward in our understanding of the potential of
MAT2501 and its broad utility to treat different types of chronic
and acute bacterial infections, NTM infections and various
multidrug-resistant gram-negative bacterial infections. We look
forward to reporting topline results of our Phase 1 clinical study
of MAT2501 for the treatment of NTM infections in the coming
weeks.”
MAT2501 is 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 five-year period of marketing
exclusivity provided by the QIDP designation, combined with the
seven-year Orphan Drug exclusivity, provides for a potential total
of 12 years of marketing exclusivity.
The Company also intends to explore the
development of MAT2501 for the treatment of a variety of multi-drug
resistant, gram negative bacterial infections.
About MAT2501
MAT2501 is an orally-administered, encochleated
formulation of the broad spectrum IV-only aminoglycoside antibiotic
agent amikacin, which utilizes the Company’s proprietary,
lipid-crystal, nanoparticle delivery technology. Amikacin is
currently used to treat different types of chronic and acute
bacterial infections, including non-tuberculous mycobacterium (NTM)
infections and various multidrug-resistant gram-negative bacterial
infections. IV-administered amikacin is associated with major side
effects including nephrotoxicity and ototoxicity (permanent loss of
hearing) with long-term use. MAT2501 is specifically designed
to provide targeted delivery of the potent antibiotic amikacin
while providing a significantly improved safety and tolerability
profile. In preclinical studies MAT2501 demonstrated oral
bioavailability and targeted delivery of amikacin directly to the
site of infection in both pulmonary (lung) and disseminated NTM
infections. In Q4 2016, Matinas initiated a Phase 1 clinical study
of MAT2501 under the open IND for the treatment of non-tuberculous
mycobacterium infections. Topline data from this Phase 1 study is
expected in Q1 2017. The FDA has already designated MAT2501 as a
QIDP and an Orphan Drug for the treatment of NTM infections. The
Company also intends develop MAT2501 for the treatment of a variety
of multi-drug resistant, gram negative bacterial infections. If
approved, we believe MAT2501 would become the first orally
bioavailable aminoglycoside and represent a significant improvement
over existing therapies in an area of significant unmet medical
need.
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 drug candidate MAT2203, currently in Phase 2, is an
orally-administered, encochleated formulation of amphotericin B (a
broad spectrum fungicidal agent). The Company has an open
Investigational New Drug (IND) application for MAT2501, currently
in Phase 1, which is an orally-administered, encochleated
formulation of amikacin (a broad spectrum aminoglycoside antibiotic
agent) for acute bacterial infections, including non-tuberculous
mycobacterium (NTM) and multi-drug resistant gram-negative
bacterial infections.
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, including MAT2203 and
MAT2501, the anticipated timing of regulatory submissions, the
anticipated timing of clinical studies, 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 maintain and derive benefit from the Qualified
Infectious Disease Product (QIDP), Orphan and/or Fast Track
designations for MAT2203 and MAT2501, which does not change the
standards for regulatory approval or guarantee regulatory approval
on an expedited basis, or at all; 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 Contact
Jenene Thomas
Jenene Thomas Communications, LLC
Phone: +1 (908) 938-1475
Email: jenene@jenenethomascommunications.com