Compassionate Use Patient Treated with Matinas BioPharma’s MAT2203 and Showing Complete Clinical Resolution of Rare R. mucilaginosa Fungal Infection Featured in Oral Presentation at ECCMID
April 18 2023 - 8:00AM
Matinas BioPharma (NYSE American: MTNB), a clinical-stage
biopharmaceutical company focused on delivering groundbreaking
therapies using its lipid nanocrystal (LNC) platform delivery
technology, announces that Marisa H. Miceli, MD, Professor of
Medicine, Specializing in Fungal Infections and Transplant
Diseases, Division of Infectious Diseases, Internal Medicine, at
the University of Michigan and her team delivered an oral
presentation earlier today at the 33rd European Congress of
Clinical Microbiology & Infectious Diseases (ECCMID) in
Copenhagen discussing MAT2203’s clinical impact in treating a
compassionate use patient suffering from Rhodotorula mucilaginosa
(R. mucilaginosa), a rare and opportunistic invasive fungal
infection.
“We are extremely pleased with the positive
clinical impact that MAT2203, oral amphotericin B, had on an
extremely ill patient with very limited treatment options,” said
Dr. Miceli. “R. mucilaginosa infection is rare and challenging to
treat, due to innate antifungal resistance requiring long-term
amphotericin B treatment, which historically leads to significant
nephrotoxicity. In our patient, IV-amphotericin B had to be
discontinued due to electrolyte abnormalities and associated
toxicities. Following transition, MAT2203 was well-tolerated, and
led to a robust clinical response with no renal adverse effects,
allowing for six continuous months of treatment with regular
outpatient monitoring. Based on our experience, MAT2203 appears to
represent a safe and well-tolerated oral treatment option that can
be safely administered in the outpatient setting to patients who
require long-term antifungal treatment with amphotericin B.”
Key elements of Dr. Miceli’s team presentation
included:
- Rhodotorula are a genus of
pigmented yeasts and represent a rare, but opportunistic and
emerging threat often highly resistant to antifungal therapy.
Patients can require months of consistent IV-amphotericin B therapy
to clear the infection, putting them at significant risk for kidney
toxicity.
- The patient was at risk of
amputation of her foot where the infection was located and was
generally unable to walk. The patient began treatment with
liposomal IV-administered amphotericin B but developed serious
kidney toxicities attributed to the use of IV-amphotericin B. As a
result, treatment with IV-amphotericin B was discontinued and Dr.
Miceli applied to Matinas’ Compassionate Use Expanded Access
Program for treatment with MAT2203.
- The patient was admitted for
monitored initiation of MAT2203 with a dosing regimen of 300mg,
four times a day.
- Following initiation with MAT2203,
the patient’s renal function improved and remained at baseline
throughout treatment. While taking MAT2203, the patient experienced
none of the electrolyte abnormalities evident while taking
IV-amphotericin B.
- The patient received MAT2203 daily
for six months and ended therapy in January 2023 following complete
clinical resolution of the fungal infection while regaining the use
of her foot.
“The outcomes observed in this compassionate use
case are highly encouraging, although we recognize the data are
limited,” said Theresa Matkovits, PhD, Chief Development Officer at
Matinas. “This is one of several cases with successful outcomes
using MAT2203 as part of our ongoing Expanded Access Program. We
are in the final stages of planning a Phase 3 program for MAT2203
with the U.S. Food & Drug Administration. Our goal is to add to
the growing body of evidence to fully evaluate the significant
potential of MAT2203 in the treatment of invasive fungal infections
and, if appropriate, support broader use of this investigational
drug.”
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 a number of 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 resulting in a lower
risk of toxicity and potentially creating the ideal antifungal
agent for the treatment of invasive fungal infections.
About ECCMID The European
Congress of Clinical Microbiology & Infectious Diseases
(ECCMID) has become one of the most comprehensive and influential
congresses in the field of infectious diseases and an exciting
networking opportunity, bringing together more than 14,000
colleagues from all over the world. The scientific program is built
by the ECCMID Programme Committee, an independent group of experts
representing all disciplines related to clinical microbiology,
infectious diseases, infection control and prevention, and public
health.
About Matinas BioPharmaMatinas
BioPharma is a biopharmaceutical company focused on delivering
groundbreaking therapies using its lipid nanocrystal (LNC) platform
delivery technology to maximize global clinical impact and patient
access. The Company is developing its own internal portfolio of
products as well as partnering with leading pharmaceutical
companies to develop novel formulations that capitalize on the
unique characteristics of the LNC platform.
Preclinical and clinical data have demonstrated
that this novel technology can provide solutions to many of the
challenges in achieving safe and effective intracellular delivery
for both small molecules and larger, more complex molecules such as
mRNA, DNA plasmids, antisense oligonucleotides, and vaccines. The
combination of a unique mechanism of action and flexibility with
formulation and route of administration (including oral) positions
Matinas’ LNC technology potentially to become the preferred
next-generation intracellular drug delivery vehicle with distinct
advantages over both lipid nanoparticles and viral
vectors. 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,
our collaborations with National Resilience, Inc. and BioNTech SE,
the potential of our LNC platform delivery technology, and the
future development of its product candidates, the Company’s ability
to identify and pursue development, licensing 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 Contact
LHA Investor RelationsJody Cain
Jcain@lhai.com310-691-7100
Matinas Biopharma (AMEX:MTNB)
Historical Stock Chart
From Jul 2024 to Aug 2024
Matinas Biopharma (AMEX:MTNB)
Historical Stock Chart
From Aug 2023 to Aug 2024