– Single ascending dose (SAD) cohort of
first-in-human Phase 1a study to evaluate safety and
pharmacokinetics of WP1122 and establish maximum tolerated dose
–
– Multiple ascending dose (MAD) cohort to
commence after completion of at least 3 SAD dosing cohorts in which
WP1122 is found to be safe and well-tolerated –
HOUSTON, May 26, 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 the
commencement of dosing in its first-in-human Phase 1a study to
evaluate the safety and pharmacokinetics (PK) of WP1122 in healthy
volunteers for the treatment of COVID-19 (MB-301). WP1122, the
Company's lead metabolism/glycosylation inhibitor, is a prodrug of
a well-known glucose decoy called 2-deoxy-D-glucose (2-DG).
Walter Klemp, Chairman and Chief
Executive Officer of Moleculin commented, "We are pleased to
commence dosing in the first group of healthy volunteers. Based on
the antiviral effect of WP1122 demonstrated in preclinical models,
we remain confident that the drug has the potential to meet the
critical need for a pan-viral therapy that could address not only
COVID-19 and its variants, but other viruses that depend upon
glycolysis and glycosylation. With dosing in our SAD cohort for the
study underway, we look forward to evaluating the safety and PK of
WP1122 as well as establishing a maximum tolerated dose (MTD) in
order to drive development forward. Importantly, establishing
safety and an MTD in this study not only sets the stage for further
antiviral development, but it also facilitates potential Phase 2
clinical trials for cancer indications."
The Phase 1a, first-in-human, randomized, double-blind,
placebo-controlled, overlapping SAD and MAD will investigate the
effects of WP1122 administered as an oral solution in healthy human
volunteers in the United Kingdom.
Dose escalation will take place in sequential SAD cohorts, and MAD
will start as soon as SAD has completed at least 3 dosing cohorts
in which WP1122 is found to be safe and well-tolerated. This study
in healthy volunteers will explore safety and PK, and subsequent
antiviral clinical development will be in patients infected with
SARS-CoV-2 to further evaluate safety and establish a favorable
risk/benefit profile. The Company expects to enroll approximately
80 subjects in this trial.
Dose escalation, during the SAD portion of this study, will
proceed up to a maximum dose of 64 mg/kg as a single dose. Dosing
of WP1122 will start in SAD at 8 mg/kg as a single dose and
escalate in two-fold increments (i.e. to 16 then 32 mg/kg as single
doses, etc.) in subsequent cohorts. Dosing of WP1122 in the MAD
cohorts will start after a dose of 32 mg/kg has been achieved in
the single dose cohort. The first dose administered in MAD will be
16 mg/kg every 12 hours (32 mg/kg/day) for 7 days and dosing in the
second MAD cohort will escalate to 32 mg/kg every 12 hours (64
mg/kg/day) for 7 days. Dosing at these levels is justified both by
the Company's non-clinical testing and by the clinical trials of
the active moiety of WP1122 (2-DG) that have been reported by
researchers unrelated to the Company.
For more information about the study, please visit
clinicaltrials.gov and reference identifier NCT05195723.
Moleculin is also in the process of identifying additional
countries where potential future Phase 2 COVID-19 clinical studies
could occur.
About WP1122
WP1122 was developed as a 2-DG prodrug to provide a more
favorable pharmacological profile and was found to have greater
potency than 2-DG alone in preclinical models where tumor cells
require higher glycolytic activity than normal cells. WP1122 has
also been shown to have a greater antiviral effect than 2-DG
against SARS-CoV-2 in MRC-5 cells in culture. The improved
pharmacokinetic and pharmacodynamic (PK/PD) profile of WP1122
compared to 2-DG was noted in female mice following oral dosing at
equimolar (i.e., equivalent levels of 2-DG) doses.
While the Company is in the process of identifying additional
countries where potential future Phase 2 COVID-19 clinical studies
could occur, the volatility and unpredictability of COVID-19
incidence in various countries may limit the ability to recruit
certain subjects and could make it infeasible to conduct a Phase 2
clinical trial there. Additionally, Moleculin recently received IND
clearance from the U.S. Food and Drug Administration (FDA) to
initiate a Phase 1 study of WP1122 for the treatment of
Glioblastoma Multiforme (GBM). The Company is seeking collaborators
with the intent to commence clinical trials of WP1122 in cancer
indications including GBM, pancreatic cancer and others.
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 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
Moleculin's preclinical models can be replicated in human trials,
Moleculin's ability to identify additional countries where
potential future Phase 2 COVID-19 clinical studies could occur,
Moleculin's ability to identify and attract collaborators for
additional clinical trials of WP1122, and the ability for WP1122 to
be shown safe and effective in humans. 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.