– Preclinical work being conducted is intended
to validate in vitro findings in established animal models to
determine if further preclinical development and human clinical
trials are warranted
– Hemorrhagic fever arenaviruses (HFA)
represent area of significant unmet need with no
FDA-approved arenavirus vaccines or therapies
HOUSTON, Sept. 27,
2022 /PRNewswire/ -- Moleculin Biotech, Inc.,
(Nasdaq: MBRX) (Moleculin or the Company), a clinical stage
pharmaceutical company with a broad portfolio of drug candidates
targeting highly resistant tumors and viruses, today announced its
WP1096 molecule (a part of its WP1122 portfolio of D-glucose and
D-mannose antimetabolites) will be evaluated in animal studies
through the preclinical services offered by the National Institute
of Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health. WP1096 is being studied by Moleculin as a
novel potential therapy for a broad spectrum of viruses, including
arenaviruses.
WP1096 is a compound within the WP1122 portfolio, which is
designed to exploit, amongst other uses, the potential uses of
monosaccharide (such as glucose or mannose) decoys as a means to
inhibit glycolysis and alter glycosylation. As an example, the
Company's WP1122 molecule is a prodrug of 2-deoxy-D-glucose (2-DG),
and 2-DG has been approved outside the US for use as a treatment
for COVID-19. The Company believes WP1096 may target and
therapeutically impact glycolysis and glycosylation processes in
host cells and viruses.
"We are encouraged by the data WP1096 has demonstrated in
preliminary studies and look forward to further evaluating its
potential as a much-needed anti-arenaviral therapy. The results of
WP1096 preliminary studies show a broader spectrum of antiviral
activity than 2-DG against hemorrhagic fever viruses (i.e.,
Argentine hemorrhagic fever, Marburg, Ebola and others), an area of
significant unmet need, thus encouraging us to pursue advancing its
development. We are grateful for this opportunity to take a step
forward in unlocking further potential of the compounds within our
WP1122 portfolio," commented Walter
Klemp, Chairman and Chief Executive Officer of
Moleculin.
Moleculin is currently conducting a Phase 1 trial of analog
WP1122 (a prodrug of 2-DG) in healthy volunteers in preparation for
a Phase 2 trial in COVID-19 patients. Between its antiviral effort
with WP1122 and a range of oncology focused initiatives, Moleculin
is not currently able to allocate significant resources to the
development of WP1096. However, considering the promising WP1096
in vitro activity in a range of potentially deadly viruses
previously demonstrated, Moleculin believes that WP1096 would be a
good candidate for animal testing in arenavirus models where there
is a significant unmet need.
The NIAID-funded animal studies will be with the Tacaribe
arenavirus, a BSL-2 (bio safety level 2) virus and will be used as
an indication of activity and as a means to optimize the animal
testing protocol. Given the significant need for treatment
alternatives in arenaviruses (and other hemorrhagic fever viruses),
if WP1096 demonstrates significant efficacy in the requested animal
studies, Moleculin intends to revise its current development
strategy to accelerate development work on WP1096.
About Moleculin Biotech,
Inc.
Moleculin Biotech, Inc. is a clinical stage pharmaceutical
company focused on the development of a broad portfolio of drug
candidates for the treatment of highly resistant tumors and
viruses. The Company's lead program, Annamycin, is a
next-generation anthracycline designed to avoid multidrug
resistance mechanisms with little to no cardiotoxicity. Annamycin
is currently in development for the treatment of relapsed or
refractory acute myeloid leukemia (AML) and soft tissue sarcoma
(STS) lung metastases.
Additionally, the Company is developing WP1066, an
Immune/Transcription Modulator designed to be capable of inhibiting
p-STAT3 and other oncogenic transcription factors while also
stimulating a natural immune response, targeting brain tumors,
pancreatic and other cancers; and WP1220, an analog to WP1066, for
the topical treatment of cutaneous T-cell lymphoma. Moleculin is
also engaged in the development of a portfolio of antimetabolites,
including WP1122, for the potential treatment of COVID-19 and other
viruses, as well as cancer indications including brain tumors,
pancreatic and other cancers.
For more information about the Company, please visit
www.moleculin.com and connect on Twitter, LinkedIn and
Facebook.
Forward-Looking
Statements
Some of the statements in this release are forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, Section 21E of the Securities Exchange Act of 1934 and the
Private Securities Litigation Reform Act of 1995, which involve
risks and uncertainties. Forward-looking statements in this press
release include, without limitation, whether the results of in
vitro testing of WP1096 can be replicated in animal models and,
eventually, in human trials, the ability of WP1096 to be
successfully tested in animals and Moleculin's ability to secure
additional support for development of WP1096. Although Moleculin
believes that the expectations reflected in such forward-looking
statements are reasonable as of the date made, expectations may
prove to have been materially different from the results expressed
or implied by such forward-looking statements. Moleculin has
attempted to identify forward-looking statements by terminology
including 'believes,' 'estimates,' 'anticipates,' 'expects,'
'plans,' 'projects,' 'intends,' 'potential,' 'may,' 'could,'
'might,' 'will,' 'should,' 'approximately' or other words that
convey uncertainty of future events or outcomes to identify these
forward-looking statements. These statements are only predictions
and involve known and unknown risks, uncertainties, and other
factors, including those discussed under Item 1A. "Risk Factors" in
our most recently filed Form 10-K filed with the Securities and
Exchange Commission ("SEC") and updated from time to time in our
Form 10-Q filings and in our other public filings with the SEC. Any
forward-looking statements contained in this release speak only as
of its date. We undertake no obligation to update any
forward-looking statements contained in this release to reflect
events or circumstances occurring after its date or to reflect the
occurrence of unanticipated events.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
MBRX@jtcir.com
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SOURCE Moleculin Biotech, Inc.