– Preliminary results of second cohort in the
first-in-human Phase 1a allow Company to proceed to 32 mg/kg dose
of WP1122 in third cohort toward establishing maximum tolerated
dose (MTD) –
– Multiple ascending dose (MAD) cohort to commence after
completion of at least 3 successful SAD dosing cohorts –
HOUSTON, July 8, 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 second cohort of the Company's
first-in-human Phase 1a study of WP1122. This cohort consisted of 8
subjects dosed with 16 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 2, the
Company deemed the cohort dose safe and well-tolerated and began
its SAD Cohort 3 with a dose escalation to 32 mg/kg.
The Phase 1a, first-in-human, randomized, double-blind,
placebo-controlled, overlapping SAD and MAD is investigating the
effects of WP1122 administered as an oral solution in healthy human
volunteers. It is the first step in a planned investigation of
WP1122 for the treatment of COVID-19. Dose escalation will take
place in sequential SAD cohorts, and MAD will start as soon as SAD
has successfully completed at least 3 dosing cohorts. This study in
healthy volunteers will explore safety and PK, and subsequent
antiviral clinical development is expected 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 trial.
Walter Klemp, Chairman and Chief
Executive Officer of Moleculin commented, "We continue to be
encouraged by the safety data demonstrated by WP1122 in the SAD
portion of our first-in-human Phase 1a study of WP1122. With two of
the SAD cohorts now completed with promising preliminary results,
we are working to enroll and complete Cohort 3 at 32 mg/kg in order
to proceed to the MAD phase of the trial toward establishing a
maximum tolerated dose. To date, WP1122 has demonstrated no dose
escalating stopping criteria, and we look forward to taking the
next step in studying the potential of WP1122 for the treatment of
certain viral diseases, including COVID-19, 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 and now to 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 shown
to be safe 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.
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
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 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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/moleculin-announces-completion-of-second-single-ascending-dose-sad-cohort-in-phase-1a-clinical-trial-of-wp1122-in-the-uk-301582757.html
SOURCE Moleculin Biotech, Inc.