– Preliminary results of third cohort in the
first-in-human Phase 1a allows Company to proceed to next single
ascending dose (SAD) of 64 mg/kg dose and the first multiple
ascending dose (MAD) cohort to commence with 32 mg/kg dose of
WP1122 –
HOUSTON, Aug. 19,
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 reported preliminary results from the third cohort of the
Company's first-in-human Phase 1a study of WP1122. This cohort
consisted of 10 subjects dosed with 32 mg/kg or placebo in the dose
escalation trial evaluating the safety and pharmacokinetics (PK) of
WP1122 in healthy volunteers in the United Kingdom (UK). Based on the overall
results in Cohort 3, the Safety Review Committee (SRC) for the
study deemed the third single ascending dose (SAD) cohort dose safe
and well-tolerated, allowing the Company to begin its fourth SAD
Cohort with a dose escalation to 64 mg/kg. Additionally, dosing of
WP1122 in the multiple ascending dose (MAD) cohorts will commence
at a total daily dose of 32 mg/kg, which has been shown to be safe
in the single dose cohort.
The Phase 1a, first-in-human, randomized, double-blind,
placebo-controlled, overlapping SAD and MAD study is investigating
the effects of WP1122 administered as an oral solution in healthy
human volunteers. It is the first step in a potential investigation
of WP1122 for the treatment of COVID-19. Furthering such an
investigation is dependent upon the volatility and unpredictability
of COVID-19 incidence in various countries and the ability to
recruit patients for a feasible study.
Dose escalation is taking place in sequential SAD cohorts, and
MAD will now begin as 3 SAD have been successfully completed. This
study in healthy volunteers is exploring safety and PK, and
possible subsequent antiviral clinical development is intended to
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 Phase 1 trial.
Walter Klemp, Chairman and Chief
Executive Officer of Moleculin commented, "WP1122 has
continued to demonstrate the favorable safety and tolerability
profile we expected. With three SAD cohorts successfully completed,
we can begin the MAD phase of the trial and are another step closer
to establishing a maximum tolerated dose. Throughout the three
completed cohorts, WP1122 has demonstrated no dose escalating
stopping criteria, and we are pleased with the progress of WP1122
toward becoming a potential treatment of certain viral diseases and
cancers."
During the SAD portion of this study, dose escalation will
proceed up to a maximum dose of 64 mg/kg as a single dose. Dosing
of WP1122 began in SAD at 8 mg/kg as a single dose and has
escalated in two-fold increments (i.e., to 16, 32 and now to 64
mg/kg as single doses) in subsequent cohorts. 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.
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 and is also in discussions with potential investigators
interested in the possible study of WP1122 in other viruses and
cancer indications.
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
might 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 in a given country. 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 other
viruses and 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 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
Moleculin's preclinical models can be replicated in human trials,
Moleculin's ability to conduct a potential future Phase 2 COVID-19
clinical study, 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.