Matinas BioPharma Reports Successful Treatment of Patient with Limb-Threatening Mucor Infection in its Oral MAT2203 Compassionate/Expanded Use Access Program
24 Juni 2024 - 2:30PM
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 the recent successful treatment of a
22-year-old male with polymicrobial necrotizing fasciitis
(flesh-eating disease) that involved drug-resistant Lichtheimia, an
angio-invasive species of the fungus Mucorales. This patient was
treated at New York Presbyterian/Weill Cornell Medical Center and
was discharged after just six weeks of treatment with MAT2203,
Matinas’ oral formulation of the potent antifungal amphotericin B.
The patient was treated under Matinas’ Compassionate/ Expanded Use
Access Program by Sharan Yadav, MD, Infectious Disease Fellow.
“Our team faced the challenge of an extremely
aggressive fungal soft tissue infection in a young patient at high
risk for amputation. Treatment with AmBisome® was initially helpful
but, as frequently seen with intravenous amphotericin, was
complicated by increasingly severe adverse effects, including
significant renal toxicity that required ICU care. Switching to
oral MAT2203 allowed us to effectively treat his infection and
allow his kidney function to return to baseline,” said Dr. Yadav.
“We were very pleased to see the patient improve on this
medication, leave the ICU, and eventually be discharged to rehab
and later to home, where he can now bear weight on his leg and walk
with assistance.”
A total of 24 patients are currently receiving
or have completed treatment with MAT2203 under the
Compassionate/Expanded Use Access Program, and four additional
cases are awaiting submission and/or FDA approval. In each
instance, the patient was not responding to azole therapy, was
unable to receive azole therapy due to drug/drug interactions or
was unable to tolerate IV-amphotericin B for an appropriate
treatment duration due to toxicity. In all patients who experienced
serious renal toxicity while receiving IV-amphotericin B who were
subsequently treated with MAT2203, renal toxicity was reversed, and
renal function returned to baseline.
“We remain very excited by the consistently
positive clinical impact of broad-spectrum, oral MAT2203,” said
Theresa Matkovits, PhD, Chief Development Officer at Matinas. “Our
Compassionate/Expanded Use Access Program continues to attract the
attention of infectious disease doctors across the country who are
treating patients with a wide variety of invasive fungal
infections. Our ORALTO Phase 3 registration trial will provide the
opportunity to further validate these results and position MAT2203
for a New Drug Application (NDA) filing with an initial indication
for the early step-down therapy for invasive aspergillosis in
patients with limited treatment options. We continue to work
diligently toward securing the ideal global development and
commercialization partnership to advance MAT2203 into Phase 3 later
this year.”
MAT2203 is not yet licensed or approved anywhere
globally.
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
refer to future events or conditions. All statements other than
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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 Contact
LHA Investor RelationsJody Cain
Jcain@lhai.com310-691-7100
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