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 University of Minnesota Medical School
researchers published results from the Phase 2 EnACT trial
evaluating MAT2203 for the treatment of cryptococcal meningitis as
a Major Article and Editor’s Choice in Clinical Infectious
Diseases, an official publication of the Infectious Diseases
Society of America (IDSA). MAT2203 is an oral and non-toxic, LNC
formulation of the potent antifungal drug amphotericin B.
David Boulware, MD, MPH, the senior investigator
of the EnACT trial and infectious disease physician at the
University of Minnesota, commented, “An orally administered
amphotericin that is broad spectrum and non-toxic sounds like the
holy grail of antifungal medicines. While further clinical trials
are needed in other fungal conditions, the EnACT trial establishes
proof of concept for the safe and effective treatment of invasive
fungal infections. In this randomized trial of 141 HIV-positive
individuals afflicted by life-threatening cryptococcal meningitis,
the oral amphotericin MAT2203 product combined with oral
flucytosine appears promising for cryptococcal meningitis with
antifungal activity, similar survival, and less toxicity than
intravenous amphotericin B. With six weeks of LNC-enabled oral
amphotericin B, statistically fewer lab abnormalities occurred than
with one week of intravenous amphotericin B.”
“We are very pleased that the important EnACT
data are being shared with the clinical and scientific community at
large through publication in this peer-reviewed journal,” said
Theresa Matkovits, Ph.D., and Chief Development Officer of Matinas.
“The results from EnACT in cryptococcal meningitis and our
experience with patients enrolled in our Compassionate/Expanded Use
Access Program support our belief that MAT2203 has the potential to
become an important part of the regimen for treatment of invasive
fungal infections, including in the highest-need patients who
require longer-term treatment and have limited or no treatment
options. The publication of the EnACT data in Clinical Infectious
Diseases is yet another milestone for our development program. We
would like to thank all the EnACT participants, our dedicated
investigators, and the entire clinical study team in Uganda for
their commitment to this important clinical trial.”
About the EnACT Phase 2
Study
EnACT was a Phase 2 prospective, randomized,
open-label, sequential cohort study, financially supported by the
National Institute of Neurological Disorders and Stroke (NINDS) of
the National Institutes of Health (NIH), evaluating the safety,
tolerability, and efficacy of MAT2203 in 100 HIV-positive persons
with cryptococcal meningitis compared to 41 persons randomized to
receive standard of care intravenous amphotericin B.
The EnACT trial included a total of four cohorts
of participants, with the first two cohorts testing MAT2203 as
early step-down therapy following initial treatment with IV
amphotericin B during the induction period, and the second two
cohorts testing MAT2203 as potentially all oral therapy. Cohorts 1
and 3 were safety lead-ins to Cohorts 2 and 4, respectively. The
induction period for all patients in each cohort (active or
control) was 14 days, followed by an additional four weeks of
treatment (active or control) during a consolidation/maintenance
period.
About Clinical Infectious Diseases
(CID)
Clinical Infectious Diseases (CID) is a
leading journal in the field of infectious disease with a broad
international readership. The Journal publishes articles on a
variety of subjects of interest to practitioners and researchers.
Topics range from clinical descriptions of infections, public
health, microbiology, and immunology to the prevention of
infection, the evaluation of current and novel treatments, and the
promotion of optimal practices for diagnosis and treatment.
Clinical Infectious Diseases is an official publication of the
Infectious Diseases Society of America and is among the most highly
cited journals in the field of infectious diseases.
About Matinas BioPharma
Matinas 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, which although highly potent, can be associated with significant
toxicity. Matinas’ LNC platform provides oral delivery of
amphotericin B without the significant nephrotoxicity otherwise
associated with IV-delivered formulations. MAT2203 also allows for
safe, longer-term use outside of a hospital setting, which could
have substantial favorable pharmacoeconomic impact. MAT2203
successfully completed the Phase 2 EnACT program in cryptococcal
meningitis, meeting its primary endpoint and achieving robust
survival. MAT2203 is being positioned for a single pivotal Phase 3
study in the treatment of aspergillosis and other invasive fungal
infections, including mucormycosis, Candida auris and other
candidiasis, and certain endemic fungal infections in persons with
limited treatment options who are unable to be treated with azoles
or echinocandins for reasons related to drug-drug interactions,
resistance or for whom these antifungal agents are unable to be
used for other clinical reasons.
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 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,
our collaboration with National Resilience, Inc., the potential of
our LNC platform and PS-NP delivery technologies, and 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 technologies 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 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
Matinas Biopharma (AMEX:MTNB)
Historical Stock Chart
Von Mai 2024 bis Jun 2024
Matinas Biopharma (AMEX:MTNB)
Historical Stock Chart
Von Jun 2023 bis Jun 2024