Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a
clinical-stage biopharmaceutical company focused on improving
the intracellular delivery of critical therapeutics through its
paradigm-changing lipid nanocrystal (LNC) platform delivery
technology, today announced that the independent Data and Safety
Monitoring Board (DSMB) of the EnACT trial (Encochleated Oral
Amphotericin for Cryptococcal Meningitis Trial) has completed a
prespecified review of the third cohort and unanimously recommended
progression to the fourth and final cohort of patients. Enrollment
in the next randomized EnACT cohort, with 40 active-treatment
patients, is expected to begin early first quarter 2022.
“Unanimous DSMB approval to proceed to cohort
four in the EnACT trial is a strong statement that MAT2203
continues to exceed the prespecified efficacy and safety thresholds
assessed in the first two cohorts,” said Theresa Matkovits, Ph.D.,
Chief Development Officer of Matinas BioPharma. “We have made
significant progress advancing MAT2203 through clinical
development, and the fourth cohort of EnACT represents a meaningful
opportunity to further validate an all-oral treatment regimen with
amphotericin B, and position MAT2203 as a potential first-line
treatment for cryptococcal meningitis. Ultimately, our goal is to
develop MAT2203 to become the preferred therapeutic option for the
treatment of most invasive fungal infections and provide physicians
and patients with an effective, convenient and safe oral
formulation of one of the most potent antifungal agents
available.”
“Our team continues to be pleased with the
performance of oral MAT2203 for the treatment of cryptococcal
meningitis,” commented David Boulware, M.D., M.P.H, Professor of
Medicine at the University of Minnesota and Principal Investigator
for the trial. “Cohort 3 of the ENACT trial tested whether starting
with an all-oral regimen of amphotericin and flucytosine would be
possible. Participants received 5 days of oral combination therapy
before a scheduled switch to intravenous amphotericin. In this
cohort with 10 participants receiving MAT2203, the direct
antifungal therapy activity measured in cerebrospinal fluid
continued to be above our pre-defined target threshold for success.
We are excited to begin the fourth cohort testing the all-oral
regimen of MAT2203 in a larger number of patients beginning in
early January.”
“The continued progression of EnACT and the
impressive data generated to date in this highly vulnerable patient
population are a clear demonstration of how our LNC platform can
unlock the full therapeutic potential of life-saving medicines,”
remarked Jerome D. Jabbour, Chief Executive Officer of Matinas. “We
believe this is further validation of how our proprietary
technology can be used to overcome significant drug delivery
challenges and we remain excited by the interest shown in the
application of the LNC platform beyond anti-infective
therapies.”
About the EnACT Study
EnACT is a Phase 2 prospective, randomized,
open-label, sequential cohort study, financially supported by the
National Institutes of Health (NIH), evaluating the safety,
tolerability and efficacy of MAT2203 in approximately 100
HIV-infected patients with cryptococcal meningitis (CM). MAT2203
utilizes the Company’s LNC platform delivery technology to orally
deliver the traditionally IV-only fungicidal drug, amphotericin
B.
The EnACT trial includes a total of four cohorts
of patients, with the first two cohorts testing MAT2203 as early
stepdown therapy following initial treatment with IV amphotericin B
during the induction period, and the second two cohorts testing
MAT2203 as potential monotherapy. The induction period for all
patients in each cohort (active or control) is 14 days, followed by
an additional four weeks of treatment (active or control) during a
consolidation/maintenance period.
All patients in the induction period of EnACT
(both control and MAT2203 arms) receive background therapy of
flucytosine, also known as 5-FC, which is specifically recommended
to be used with amphotericin B as standard-of-care treatment during
induction in patients with CM. During the consolidation/maintenance
period, all patients (both control and MAT2203 arms) receive 800
mg/day of fluconazole. An independent DSMB oversees the safety of
the study and reviews all available data from each cohort for both
safety and efficacy and makes a recommendation on whether to
proceed to the next cohort of patients.
In the MAT2203 arm of Cohort 1, 10 patients
received IV amphotericin B (with 5-FC) for the first five days of
induction, followed by ten days (overlapped on day 5) of oral
MAT2203 (with 5-FC). In the MAT2203 arm of Cohort 2, 40 patients
first received IV amphotericin B (with 5-FC) for two days, followed
by thirteen days (overlapped on Day 2) of oral MAT2203 (with 5-FC).
In both Cohorts 1 and 2, treatment with MAT2203 was continued after
induction during the next four weeks of consolidation/maintenance
treatment, administered with 800 mg/day of fluconazole.
In the MAT2203 arm of Cohort 3, 10 patients
received 5 days of oral MAT2203 (with 5-FC), followed by 10 days
(overlapped on Day 5) of IV amphotericin (with 5-FC). In the
MAT2203 arm of Cohort 4, 40 patients will receive MAT2203 (with
5-FC) for the entire 14-day induction period. In both Cohorts 3 and
4, treatment with MAT2203 will continue after induction during the
next four weeks of consolidation/maintenance treatment,
administered alongside 800 mg/day of fluconazole.
The primary efficacy endpoint for EnACT is the
quantitative microbiologic clearance rate of Cryptococcus yeasts
from CSF, termed Early Fungicidal Activity (EFA). This is a
quantitative measurement of the efficacy of antifungal agents as
well as a key surrogate marker for survival. The primary EFA
endpoint is measured from the first CSF culture with 3-4 repeated
cultures obtained over the first two weeks of treatment. The
prespecified endpoint threshold was achieving EFA >0.20 log10
CFU/mL/day, recognizing that EFAs of less than 0.20 are strongly
associated with significantly higher mortality and worse clinical
outcomes.
Standard of care active control HIV patients
with cryptococcal meningitis (a total of 40 across all 4 cohorts)
are included in EnACT, primarily to assess patient safety. The
control arms for Cohorts 1, 2 and 3 included 4, 17 and 4 patients,
respectively, and we expect that the control arm for Cohorts 4 will
include 16 patients. In the control arms, patients receive IV
amphotericin (with 5-FC) for 7 days, followed by a high dose of
oral fluconazole for 7 days (to complete the 14-day induction
period), and then transition to 800 mg/day of fluconazole for the
4-week consolidation phase. Either amphotericin B deoxycholate or
liposomal amphotericin B (AmBisome®) can be used in the control
arm. EnACT was not powered to formally test comparisons with the
control arm standard of care.
The FDA has designated MAT2203 as a Qualified
Infectious Disease Product (QIDP) with Fast Track status for four
indications, specifically, the prevention of invasive fungal
infections due to immunosuppressive therapy, and the treatment of
invasive candidiasis, invasive aspergillus and cryptococcal
meningitis. In addition, the FDA has granted orphan drug
designation to MAT2203 for the treatment of cryptococcosis.
About Matinas BioPharma
Matinas BioPharma is a biopharmaceutical company
focused on improving the intracellular delivery of critical
therapeutics through its paradigm-changing lipid nanocrystal (LNC)
delivery platform. The Company is developing its own internal
portfolio of products as well as partnering with leading
pharmaceutical companies to develop new formulations that take full
advantage of the unique characteristics of the LNC platform.
Preclinical and clinical data have demonstrated
that this novel technology can provide solutions to many of the
complex 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 in both the formulation and route of administration
(including oral), position Matinas’ LNC technology to potentially
become the preferred next-generation intracellular drug delivery
vehicle and an important improvement over both lipid nanoparticles
and viral vectors.
MAT2203 is an oral, LNC formulation of the
highly effective, but also highly toxic, antifungal medicine
amphotericin B, primarily used as a first-line treatment for
invasive fungal infections. MAT2203 is currently in a Phase 2
open-label, sequential cohort study (EnACT) in HIV-infected
patients with cryptococcal meningitis. The DSMB unanimously
approved the progression of EnACT into the fourth and final cohort
of patients in December of 2021. Cohort 4 is scheduled to begin in
January of 2022, with data expected in the second half of 2022.
MAT2501 is an oral, LNC formulation of the
broad-spectrum aminoglycoside antibiotic amikacin, primarily used
to treat chronic and acute bacterial infections. With the support
of the Cystic Fibrosis Foundation, MAT2501 is currently undergoing
important preclinical studies and commenced a Phase 1 human
clinical trial in the fourth quarter of 2021. MAT2501 would be the
first and only oral aminoglycoside, and is being positioned with an
initial indication for the treatment of nontuberculous
mycobacterial (NTM) lung disease, including infections in patients
with cystic fibrosis.
LYPDISO™, is a prescription-only omega-3 fatty
acid-based composition, comprised primarily of EPA and DPA,
intended for the treatment of cardiovascular and metabolic
conditions. This next-generation omega-3 therapy has been shown in
two head-to-head studies to provide effective triglyceride-lowering
and significantly higher EPA blood levels than Vascepa®. The
Company has initiated a process to identity and potentially secure
a partner to continue development of LYPDISO.
Forward Looking Statements
This 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 potential of our LNC
platform delivery technology, and the future development of its
product candidates, including MAT2203, MAT2501, the anticipated
timing of regulatory submissions, the anticipated timing of
clinical studies, the anticipated timing of regulatory
interactions, the Company’s ability to identify and pursue
development 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 and Media Contacts
Peter VozzoICR
Westwicke443-213-0505peter.vozzo@westwicke.com
Source: Matinas BioPharma Holdings, Inc.
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