Matinas BioPharma Holdings, Inc. (NYSE American: MTNB), a
clinical-stage biopharmaceutical company focused on delivering
groundbreaking therapies using its lipid nanocrystal (LNC) platform
technology, announces results from a series of in vivo studies
demonstrating successful oral delivery of two LNC-formulated small
single-strand oligonucleotides that specifically target key
inflammatory cytokines TNFα and IL-17A in well-established and
validated animal models that mimic acute inflammatory responses
seen in human diseases.
“These studies demonstrate successful oral
delivery and biological activity of two different LNC-formulated
small oligonucleotides targeting inflammatory cytokines with
reductions in tissue cytokine mRNA in both colitis and psoriasis,
along with significant reductions in serum TNFα levels in colitis.
Commensurate improvements in clinical disease markers and scores
were also documented in both models,” said James Ferguson, M.D.,
Matinas’ Chief Medical Officer.
“While additional study is warranted, the
successful oral delivery of small oligonucleotides is very exciting
and we believe these data demonstrate how Matinas’ LNC platform
could be used for the oral delivery of functional small
oligonucleotides with potential therapeutic applications,” Dr.
Ferguson added. “Importantly, the unique nature of the
particular oligonucleotides evaluated in these studies, which
interfere with cytokine synthesis rather than simply targeting the
cytokine itself, creates additional opportunities for potential
future applications of LNC-delivered therapeutics, either alone or
in combination with other therapeutics with different mechanisms of
action.”
Earlier this year, Matinas established the in
vitro potency of these proprietary oligonucleotides and their LNC
formulations in knocking down their respective cytokine targets in
cultured cells. Both were advanced to in vivo studies to evaluate
meaningful biological activity in relevant disease models.
Acute Colitis Study (TNFα)
A dextran sulfate sodium (DSS)-induced murine
colitis model was used to evaluate an orally administered
LNC-delivered small oligonucleotide that specifically targets TNFα
mRNA synthesis. Colon tissue TNFα mRNA levels, as assessed by
quantitative real-time PCR analysis, were lower following orally
administered active LNCs, resulting in statistically significant
reductions of serum TNFα levels by 37% compared with diseased, but
untreated animals. Importantly, clinical disease activity scores at
key time points in the studies were also significantly improved
with an active LNC formulation.
Acute Psoriasis Study
(IL-17A)
An imiquimod (IMQ)-induced murine psoriasis
model was used to evaluate an orally administered, LNC-delivered
small oligonucleotide designed to inhibit IL-17A mRNA synthesis,
which contributes significantly to the progression of psoriatic
skin lesions. Similar to the DSS colitis model, skin tissue levels
of IL-17A mRNA in the IMQ psoriasis model were lower with orally
administered active LNCs compared with IMQ alone. In this model,
while IL-17A serum levels were not expected to change, improvement
was demonstrated in clinical disease markers of skin redness and
scaling, further validating the biological activity of these small
oligonucleotides.
Additional tissue and histologic analyses from
both studies are ongoing and the Company plans to present these
data at future scientific meetings.
“We believe that our proprietary encapsulation
and oral delivery methods could be applied to other small
oligonucleotides, including RNAi therapeutics such as siRNA and
antisense oligonucleotides,” said Jerome D. Jabbour, Chief
Executive Officer of Matinas. “While a variety of methods for
administering small oligonucleotides exist, most are primarily
directed to the liver, and none provide oral administration and
delivery capabilities. The opportunity to orally deliver
small oligonucleotides with extra-hepatic targeting could be key
differentiating features in rapidly advancing anti-inflammatory
therapy.
“We plan to further review the data from these
inflammatory disease models to determine the best path forward for
this program,” he added. “Further study and optimization of these
LNC-delivered small oligonucleotides will be required to assess the
most appropriate therapeutic targets and the associated magnitude
of benefit.”
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, 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 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.
In addition to MAT2203, preclinical and clinical
data have demonstrated that this novel technology can potentially
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 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 potential of our LNC platform technology, 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
CainJcain@lhai.com310-691-7100
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