In Vivo Efficacy of Matinas BioPharma’s Oral MAT2203 in Pulmonary Mucormycosis Published in Journal of Antimicrobial Agents and Chemotherapy
30 April 2024 - 10:00PM
Matinas BioPharma Holdings, Inc. (NYSE American: MTNB), a
clinical-stage biopharmaceutical company focused on delivering
groundbreaking therapies using its lipid nanocrystal (LNC) platform
delivery technology, announces that MAT2203, its oral formulation
of the potent antifungal amphotericin B, demonstrated efficacy
compared with placebo in treating the pulmonary mucormycosis fungal
infections Rhizopus delemar and M. circinelloides f. jenssenii in
immunosuppressed mice. Efficacy was demonstrated by prolonged
median survival time, enhanced overall survival, reduced tissue
fungal burden of target organs and improved histological
architecture of infected lungs. In addition, MAT2203 activity
appeared to be similar to IV-amphotericin B in survival studies in
the M. circinelloides f. jenssenii mouse model.
The study results are reported in the manuscript
“Efficacy of an oral lipid nanocrystal (LNC) formulation of
amphotericin B (MAT2203) in the neutropenic mouse model of
pulmonary mucormycosis” (Gu, et al.) published in the peer-reviewed
Journal of Antimicrobial Agents and Chemotherapy
(https://journals.asm.org/doi/10.1128/aac.01540-23). The manuscript
is available on the Matinas website here.
“The promising outcomes of MAT2203 in these
studies represent a significant step towards a less invasive and
safer treatment approach to combating invasive mucormycosis, since
unlike liposomal amphotericin B (LAMB) which is given
intravenously, MAT2203 is administered orally and can be
administered long-term without any of the significant toxicities
associated with LAMB treatment,” said lead manuscript author Ashraf
Ibrahim, PhD at the Lundquist Institute for Biomedical Innovation
at Harbor-UCLA Medical Center. “It's a testament to the potential
of innovative drug delivery systems like lipid nanocrystals in
transforming how we treat infectious diseases."
“Mucormycosis is frequently a life-threatening
infection. A review of published mucormycosis cases found an
overall all-cause mortality rate of 54%. The drugs currently used
to treat mucormycosis are delivered intravenously and can be toxic.
MAT2203, our oral formulation of amphotericin B, has been shown to
effectively and safely deliver this potent antifungal in
mucormycosis and a variety of other potentially deadly invasive
fungal infection through our Compassionate/Expanded Use Access
Program (Program). Early results through our Program and promising
in vivo studies in difficult-to-treat mucormycosis infections
continue to strengthen our confidence in MAT2203’s potential
efficacy and safety in treating a variety of invasive fungal
infections,” commented Dr. Theresa Matkovits, Chief Development
Officer at Matinas. “These results also further support the
anticipated positive clinical data from our Phase 3 ORALTO
registration trial evaluating the efficacy and safety of MAT2203 as
an early oral step-down therapy to IV-amphotericin B in severely
ill patients with invasive aspergillosis who have limited treatment
options.”
About MAT2203Matinas BioPharma
is developing MAT2203 as a potential oral broad-spectrum treatment
for invasive deadly fungal infections. Although amphotericin B is a
fungicidal agent, it is currently only available through an
intravenous route of administration, which is known to be
associated with several significant safety issues such as renal
toxicity and anemia due to very high circulating levels of
amphotericin B. MAT2203 has the potential to overcome the
significant limitations of the currently available amphotericin B
products due to its targeted oral delivery. Combining comparable
fungicidal activity with targeted delivery results in a lower risk
of toxicity and potentially creates the ideal antifungal agent for
the treatment of invasive fungal infections. MAT2203 was
successfully evaluated in the completed Phase 2 EnACT study in HIV
patients suffering from cryptococcal meningitis, meeting its
primary endpoint, and achieving robust survival. MAT2203 will be
further evaluated in a single Phase 3 registration trial (the
“ORALTO” trial) as an oral step-down monotherapy following
treatment with AmBisome® (liposomal amphotericin B) compared with
the standard of care in patients with invasive aspergillosis who
have limited treatment options.
About Matinas BioPharmaMatinas
BioPharma is a biopharmaceutical company focused on delivering
groundbreaking therapies using its lipid nanocrystal (LNC) platform
delivery technology.
In addition to MAT2203, preclinical and clinical
data have demonstrated that this novel technology can potentially
provide solutions to many challenges of achieving safe and
effective intracellular delivery of both small molecules and
larger, more complex molecular cargos including small
oligonucleotides such as ASOs and siRNA. The combination of its
unique mechanism of action and flexibility with routes of
administration (including oral) positions Matinas’ LNC technology
to potentially become a preferred next-generation orally available
intracellular drug delivery platform. For more information, please
visit www.matinasbiopharma.com.
Forward-looking StatementsThis
release contains "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995, including
those relating to our business activities, our strategy and plans,
the future development of its product candidates, including
MAT2203, the Company’s ability to identify and pursue development,
licensing and partnership opportunities for its products, including
MAT2203, 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
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factors which may cause actual results to be materially different
from any future results expressed or implied by the forward-looking
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risks and uncertainties, including, but not limited to, our ability
to continue as a going concern, 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 ContactLHA Investor
RelationsJody Cain Jcain@lhai.com310-691-7100
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