– Dosing for first-in-human Phase 1a study to
evaluate safety and pharmacokinetics of WP1122 in healthy
volunteers and establish maximum tolerated dose expected to
commence imminently –
HOUSTON, May 10, 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 that
it has received approval from the United
Kingdom's (UK) MHRA to proceed with a first-in-human Phase
1a study to evaluate the safety and pharmacokinetics of WP1122 in
healthy volunteers for the treatment of COVID-19 (MB-301). The
approval follows Moleculin's having submitted a protocol amendment
allowing for a higher ratio of diluting excipients to drug
substance to facilitate a faster and simpler mixing procedure
before drug administration.
Walter Klemp, Chairman and Chief
Executive Officer of Moleculin commented, "Approval of the
protocol amendment from the MHRA is another encouraging step
forward. We believe the antiviral effect demonstrated by WP1122 in
preclinical models to-date suggests that the drug may have the
potential to meet the critical need for a pan-viral therapy that
could address not only COVID-19 and its variants, but also other
viruses that cause human disease. As we are also developing this
drug for human cancers, this Phase 1 trial may also provide
information that helps advance our cancer research. We remain
committed to advancing the development of WP1122 and look forward
to the commencement of dosing in healthy volunteers, which we
expect later this month."
WP1122, the Company's lead metabolism/glycosylation inhibitor,
is a prodrug of a well-known glucose decoy called 2-deoxy-D-glucose
(2-DG), currently being developed for inhibition of viral
replication and disease manifestations in humans infected with
SARS-CoV-2, the virus responsible for COVID-19. The mechanism of
action of 2-DG includes both the inhibition of glycolysis and the
disruption of glycosylation, two processes that are important to
both viral activity and tumor development. 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
more potent antiviral effect than 2-DG against SARS-CoV-2 in MRC-5
cells (one of the most common human-derived cell lines used for
antiviral research) in culture.
The Phase 1a study in healthy human volunteers will investigate
the effects of a single ascending dose (SAD) and multiple days of
ascending dosing (MAD) of WP1122 administered as an oral solution.
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 pharmacokinetics
(PK), and subsequent 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 healthy volunteers in the United Kingdom.
For more information about the study, please visit
clinicaltrials.gov and reference identifier NCT05195723.
Moleculin Biotech 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.
The Company is also in the process of identifying additional
countries where potential future Phase 2 COVID-19 clinical studies
could occur, although 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), which the Company expects to
commence in 2022.
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, the commencement date of the
Phase 1a study, whether the results of Moleculin's preclinical
models can be replicated in human trials, and Moleculin's ability
to identify additional countries where potential future Phase 2
COVID-19 clinical studies could occur. 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.