Patient with Candida krusei Infection in Matinas BioPharma’s Oral MAT2203 Expanded Access Program Achieves Complete Clinical Resolution
11 Octubre 2023 - 6:30AM
Matinas BioPharma (NYSE American: MTNB), a clinical-stage
biopharmaceutical company focused on delivering groundbreaking
therapies using its lipid nanocrystal (LNC) platform delivery
technology, announces complete clinical resolution of a patient’s
recurrent hemorrhagic cystitis due to Candida krusei (C. krusei), a
fluconazole inherited resistant fungal pathogen, following
treatment with MAT2203, Matinas’ oral formulation of the potent
antifungal amphotericin B. This patient was treated under Matinas’
Expanded Access/Compassionate Use Program by 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.
“We are thrilled with the positive clinical
impact MAT2203 had on this extremely ill patient with limited
treatment options,” said Dr. Miceli. “This 61-year-old male with a
history of diabetes, kidney disease, chronic obstructive lung
disease, and coronary heart disease with heart failure had
developed recurrent hemorrhagic cystitis due to C. krusei. In this
case, neither an echinocandin nor a second-generation triazole was
an option due to their inability to deliver adequate drug levels in
urine. Treatment with IV-amphotericin B deoxycholate was quickly
discontinued due to renal toxicity and we transitioned this patient
to MAT2203, which was well-tolerated with no adverse effects.
Treatment with MAT2203 led to complete resolution of his symptoms
and improvement of his kidney function to baseline. Ultimately, the
patient’s urine culture was negative for C. krusei after just 14
days of treatment with MAT2203.”
A total of 11 patients with no other treatment
options are currently receiving or have completed treatment with
MAT2203 under this program, and several additional cases are under
consideration. In each instance, the patient was not responding to
or was resistant to azole therapy or was unable to receive azole
therapy due to drug/drug interactions. All patients who experienced
serious renal toxicity while receiving IV-amphotericin B who were
subsequently treated with MAT2203 saw their renal toxicity reversed
and renal function return to normal.
“It’s exciting to share the ongoing, consistent
positive clinical impact of our broad-spectrum, fast-acting oral
MAT2203, especially with a major infectious disease conference,
IDWeek, kicking off today,” said Theresa Matkovits, PhD, Chief
Development Officer at Matinas. “We look forward to advancing
MAT2203 into a Phase 3 registration trial to evaluate its potential
in patients suffering from invasive aspergillosis who have limited
or no treatment options. We believe that oral, effective, and safe
MAT2203, if approved, would represent a dramatic improvement to
current clinical standard of care and become the treatment of
choice for patients and physicians battling invasive fungal
infections. We are grateful to the participants in our Expanded
Access program and to their physicians for recognizing the clinical
potential of MAT2203 in treating a broad spectrum of invasive
fungal infections.”
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. MAT2203 was
successfully evaluated in the completed Phase 2 EnACT study in
cryptococcal meningitis, meeting its primary endpoint and achieving
robust survival. MAT2203 will be further evaluated as an oral
step-down monotherapy treatment following IV-amphotericin B in a
single pivotal Phase 3 study in the treatment of aspergillosis in
persons with limited treatment options who are unable to be treated
with azoles for reasons related to drug-drug interactions,
resistance or for whom these antifungal agents are unable to be
used for other clinical reasons.
About Matinas BioPharmaMatinas
BioPharma is a biopharmaceutical company focused on delivering
groundbreaking therapies using its lipid nanocrystal (LNC) platform
delivery technology.
Matinas’ lead LNC-based therapy is MAT2203, an
oral formulation of the broad-spectrum antifungal drug amphotericin
B. In addition to MAT2203, preclinical and clinical data have
demonstrated that this novel technology can provide solutions to
many of the challenges standing in the way of achieving safe and
effective intracellular delivery of both small molecules and
larger, more complex molecular cargos such as RNAi, antisense
oligonucleotides, and vaccines. 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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forward-looking statements. Forward-looking statements include
words such as "expects," "anticipates," "intends," "plans,"
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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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