BOSTON, April 3,
2023 /PRNewswire/ -- NeuroBo Pharmaceuticals,
Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company
primarily focused on cardiometabolic diseases, today announced that
it has submitted an Investigational New Drug (IND) application to
the U.S. Food and Drug Administration (FDA). The IND application
supports a Phase 2a clinical trial of DA-1241, a
novel G-Protein-Coupled Receptor 119 (GPR119) agonist, in
development for the treatment of nonalcoholic
steatohepatitis (NASH).
"Filing of the IND for DA-1241 marks the first significant
milestone for NeuroBo since acquiring the rights to this very
promising cardiometabolic asset which is targeted to address the
underserved NASH market," stated Joe
Hooker, Interim President and Chief Executive Officer of
NeuroBo. "I would like to thank our entire team, who worked
tirelessly to move this asset into the IND process, ahead of
schedule, bringing us one step closer in the development of this
potential therapy, for which there are currently no approved
treatments.
"Based on preclinical evidence generated, to date,
administration of DA-1241 has shown reduced hepatic steatosis,
inflammation, and fibrosis, as well as improved lipid metabolism
and glucose control regardless of body weight reduction.
Additionally, in Phase 1a/1b clinical
studies, DA-1241 was well tolerated in both healthy volunteers and
in patients with type 2 diabetes (T2D). It is our belief, based on
this evidence, that the mechanism of DA-1241 will translate into a
safe and effective treatment for NASH. We look forward to
initiating the clinical development for DA-1241 and, if regulatory
review of our IND is completed, key upcoming milestones for this
program include enrollment of our first patient, expected in the
third quarter of this year, with data targeted for the second half
of 2024. We also intend to advance our second cardiometabolic
asset, DA-1726, through the IND process this year, with the goal of
initiating a Phase 1a safety study in the first half of next year,
for which data would also be expected in the second half of the
year. We are excited about the new direction of the company as well
as the potential of these assets and look forward to executing on
these new pipeline programs."
The Phase 2a trial of DA-1241 is expected to be a 16-week,
multicenter, randomized, double-blind, placebo-controlled, parallel
arm study to evaluate the efficacy and safety of DA-1241 in
subjects with presumed NASH. The trial is expected to enroll a
total of 87 subjects, with a planned maximum of 98 subjects to
account for early discontinuations, who will be randomized into 4
treatment groups and will be dosed with: DA-1241 50 mg, DA-1241 100
mg, DA-1241 100 mg/Sitagliptin 100 mg, or Placebo in a 1:2:2:2
ratio. Randomization will be stratified by Type 2 Diabetes Mellitus
(T2DM) status at baseline. The primary endpoint is the change from
baseline in alanine transaminase (ALT) levels at Week 16/Day 112.
Secondary efficacy endpoints include the proportion of subjects
with normalization of ALT, relative percent change in liver fat
fraction from baseline, absolute change in liver fat from baseline,
and proportion of subjects with a 30% or more reduction in liver
fat from baseline, among others. Safety will be evaluated by
monitoring adverse events (AEs) including determination of serious
adverse events (SAEs) and AEs leading to discontinuation and
laboratory abnormalities as characterized by type, frequency,
timing, severity (mild, moderate, severe), seriousness and
relationship to DA-1241, vital signs measurements, clinical
laboratory tests and electrocardiogram (ECG) assessments.
About DA-1241
DA-1241 is a novel
G-Protein-Coupled Receptor 119 (GPR119) agonist with
development optionality as a standalone and/or
combination therapy for both NASH and T2D. Agonism of
GPR119 in the gut promotes the release of key gut peptides
GLP-1, GIP, and PYY. These peptides play
a further role in glucose metabolism, lipid metabolism and weight
loss. DA-1241 has beneficial effects on glucose, lipid profile and
liver inflammation, supported by potential efficacy demonstrated
during in vivo preclinical studies. The therapeutic
potential of DA-1241 has been demonstrated in multiple pre-clinical
animal models of NASH and T2D where DA-1241 reduced hepatic
steatosis, inflammation, fibrosis, and improved glucose
control. Furthermore, in Phase 1a and 1b human trials DA-1241 was well tolerated in
both healthy volunteers and those with T2D.
About NeuroBo Pharmaceuticals
NeuroBo
Pharmaceuticals, Inc., is a clinical-stage biotechnology
company focused primarily on therapies for cardiometabolic
diseases. Its primary therapeutics programs include DA-1241
and DA-1726. DA-1241 is a novel G-Protein-Coupled Receptor 119
(GPR119) agonist, which promotes the release of key
gut peptides GLP-1, GIP and PYY, which,
in turn, play an important role in glucose metabolism, lipid
metabolism and weight loss. DA-1726 is a novel oxyntomodulin
(OXM) analogue functioning as a
glucagon-like peptide-1 receptor (GLP1R) and glucagon
receptor (GCGR) dual
agonist. OXM is a naturally-occurring, 37-amino
acid peptide hormone that is released from the gut after ingestion
of a meal, activating both the GLP-1 and glucagon
receptors, prompting reduced food intake as well as an
increase in energy expenditure, potentially resulting in superior
body weight loss compared to selective GLP-1 receptor
agonists. For more information, please
visit www.neurobopharma.com.
Forward Looking Statements
Certain statements in
this release may be considered forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including without limitation, statements about the closing of
the offering of securities. Forward-looking statements are
predictions, projections and other statements about future events
that are based on current expectations and assumptions and, as a
result, are subject to risks and uncertainties. Many factors could
cause actual future events to differ materially from the
forward-looking statements in this release, including, without
limitation, those risks associated with our ability to execute on
our commercial strategy, the timeline for regulatory submissions,
regulatory steps and potential regulatory approval of our current
and future product candidates, the ability to realize the benefits
of the license agreement with Dong-A ST Co. Ltd., including the
impact on future financial and operating results of
NeuroBo; the ability to integrate the new product candidates
into NeuroBo's business in a timely and cost-efficient
manner; the cooperation of our contract manufacturers, clinical
study partners and others involved in the development of our
current and future product candidates; our ability to recruit
subjects for our clinical trials; costs related to the license
agreement, known and unknown, including costs of any litigation or
regulatory actions relating to the license agreement; changes in
applicable laws or regulations; effects of changes to
NeuroBo's stock price on the terms of the license agreement
and any future fundraising; and other risks and uncertainties
described in our filings with the SEC. Forward-looking statements
speak only as of the date when made. NeuroBo does not
assume any obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Contact:
Rx Communications Group
Michael
Miller
+1-917-633-6086
mmiller@rxir.com
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SOURCE NeuroBo Pharmaceuticals, Inc.