HOUSTON, April 6, 2021 /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 engagement of IQVIA Biotech, a contract
research organization (CRO) to manage the Company's effort to begin
potential clinical trials of WP1122 for the treatment of
COVID-19.
"Our teaming up with IQVIA, a preeminent, global CRO, is
intended to facilitate the advancement into possible clinical
trials for WP1122 with the objective of determining our drug's
potential for treating COVID-19," commented Walter Klemp, Moleculin's Chairman and CEO. "We
continue to believe the best possible pathway for development may
be outside the US, given the FDA's requirement that we complete an
analysis in a COVID-19 animal model before submitting a request for
US investigational new drug (IND) status. Unfortunately,
validated COVID-19 animal models are in high demand, resulting in a
long lead time before that can be done. In the meantime, we
believe all of the necessary preclinical safety testing has now
been completed to qualify for the equivalent of an IND outside the
US. Over the last quarter, we completed our pre-clinical data,
interviewed CRO's and decided that IQVIA Biotech has the experience
and reach to best serve our clinical needs for this project. In
addition, considering that the active ingredient in WP1122 is
2-deoxy-D-glucose (2-DG) and that 2-DG has now shown efficacy in a
Phase 2 clinical trial conducted by an unrelated drug developer
outside of the US, we believe that a sufficient efficacy rationale
for WP1122 already exists to begin clinical trials."
WP1122 is a prodrug of 2-DG, a well-known antimetabolite with
the ability to inhibit glycolysis and alter glycosylation, two
processes critical to coronaviruses like SARS-CoV-2, the virus
responsible for COVID-19. Although 2-DG has shown activity
against SARS-CoV-2, other coronaviruses and other
non-coronaviruses, we believe its therapeutic potential is limited
by its inherent lack of drug-like properties. WP1122 was
designed to improve the drug-like characteristics of 2-DG,
specifically, increasing circulation time and tissue and organ
uptake and concentration (often referred to as improved
"pharmacokinetics"). Moleculin has sponsored multiple in
vitro analyses showing activity of WP1122 against coronaviruses
superior to that of 2-DG alone, as well as preclinical animal tumor
models (WP1122 was originally developed as a potential cancer drug)
showing the improved pharmacokinetics of WP1122.
For additional information on WP1122 and its potential to treat
both viruses and cancers, please visit
http://www.moleculin.com.
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a clinical stage pharmaceutical
company focused on the development of a broad portfolio of oncology
drug candidates for the treatment of highly resistant tumors and
viruses. The Company's clinical stage drugs are: Annamycin, a Next
Generation Anthracycline, designed to avoid multidrug resistance
mechanisms with little to no cardiotoxicity being studied for the
treatment of relapsed or refractory acute myeloid leukemia, more
commonly referred to as AML, 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 cancer and hematologic
malignancies, and WP1220, an analog to WP1066, for the topical
treatment of cutaneous T-cell lymphoma. Moleculin is also engaged
in preclinical development of additional drug candidates, including
other Immune/Transcription Modulators, as well as WP1122 and
related compounds capable of Metabolism/Glycosylation
Inhibition.
For more information about the Company, please visit
http://www.moleculin.com.
About IQVIA
IQVIA (NYSE:IQV) is a leading global
provider of advanced analytics, technology solutions, and clinical
research services to the life sciences industry. IQVIA creates
intelligent connections across all aspects of healthcare through
its analytics, transformative technology, big data resources and
extensive domain expertise. IQVIA Connected Intelligence™ delivers
powerful insights with speed and agility — enabling customers to
accelerate the clinical development and commercialization of
innovative medical treatments that improve healthcare outcomes for
patients. With approximately 70,000 employees, IQVIA conducts
operations in more than 100 countries.
IQVIA is a global leader in protecting individual patient
privacy. The company uses a wide variety of privacy-enhancing
technologies and safeguards to protect individual privacy while
generating and analysing information on a scale that helps
healthcare stakeholders identify disease patterns and correlate
with the precise treatment path and therapy needed for better
outcomes. IQVIA's insights and execution capabilities help biotech,
medical device and pharmaceutical companies, medical researchers,
government agencies, payers and other healthcare stakeholders tap
into a deeper understanding of diseases, human behaviour and
scientific advances, in an effort to advance their path toward
cures. To learn more, visit www.iqvia.com.
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 ability of Moleculin to obtain
approval for the foreign equivalent of an IND for WP1122 and the
ability of WP1122 to show safety and efficacy in COVID-19 patients.
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.
Contact: James Salierno,
jsalierno@theruthgroup.com
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SOURCE Moleculin Biotech, Inc.