Initiation of Phase 2a Clinical Trial Expected
to Occur in Q3 2023
BOSTON, May 2, 2023
/PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq:
NRBO), a clinical-stage biotechnology company on a quest to
transform cardiometabolic diseases, today announced that the U.S.
Food and Drug Administration (FDA) has cleared its Investigational
New Drug (IND) application for DA-1241, a novel G-Protein-Coupled
Receptor 119 (GPR119) agonist. The company plans to initiate a
two-part, Phase 2a clinical trial of DA-1241, for the treatment of
nonalcoholic steatohepatitis (NASH), in the third quarter of
2023.
"Clearance of the IND for DA-1241 brings us one step closer to
our goal of bringing this very promising cardiometabolic asset into
clinical trials in patients with NASH, for which there is currently
no approved treatment," stated Joe
Hooker, Interim President and Chief Executive Officer of
NeuroBo. "In Phase 1a/1b clinical
studies, DA-1241 was well tolerated in both healthy volunteers and
in patients with type 2 diabetes mellitus (T2DM). Importantly,
preclinical studies demonstrated that DA-1241 attenuated NASH
progression by reducing pro-inflammatory cytokines and chemokines,
stellate cell activation, and collagen deposition in the liver,
thereby improving inflammation, hepatic steatosis, and fibrosis. In
those studies, DA-1241 also improved both lipid metabolism and
glucose control. For these reasons, we believe that the mechanism
of action of DA-1241 will translate into a safe and effective
treatment for NASH. We are eager to initiate the two-part, Phase 2a
clinical trial of DA-1241, which we expect will occur in the third
quarter of this year. The two-part design provides optionality for
an interim analysis in the first half of 2024 and we anticipate
full data in the second half of 2024.
"Looking ahead, we expect additional, near-term value creating
milestones, including advancement of DA-1726, our second asset,
through the IND process, with the goal of initiating a Phase 1a
safety study in the first half of 2024 and an expected data readout
in the second half of 2024. DA-1726 is a novel oxyntomodulin (OXM)
analogue that acts as a glucagon-like peptide-1 receptor (GLP1R)
and glucagon receptor (GCGR) dual agonist. The drug candidate is in
development for the treatment of obesity and has demonstrated
superior body weight loss in preclinical studies compared with
other selective GLP1R agonists.
"It is truly an exciting time at NeuroBo, following the recent
in-licensing of DA-1241 and DA-1726, with a new focus on
cardiometabolic diseases and the enormous NASH, obesity, and T2DM
markets."
The two-part, Phase 2a trial of DA-1241 is designed to be a
16-week, multicenter, randomized, double-blind, placebo-controlled,
parallel clinical study to evaluate the efficacy and safety of
DA-1241 in subjects with presumed NASH and confirmed pre-diabetes
or T2DM. Part 1 will explore the efficacy of DA-1241 versus
placebo, and is expected to enroll 49 subjects, with a planned
maximum of 55 subjects to account for early discontinuations.
Subjects will be randomized in a 1:2:1 ratio into 3 treatment
groups: DA-1241 50 mg, DA-1241 100 mg, or placebo. Part 2 will
explore the efficacy of DA-1241 in combination with sitagliptin,
versus placebo, and will begin after completion of a confirmatory
preclinical safety study of DA-1241 in combination with
sitagliptin. It is expected to enroll 37 subjects, with a planned
maximum of 43 subjects to account for early discontinuations, and
subjects will be randomized in 2:1 ratio into 2 treatment groups:
DA-1241 100 mg/sitagliptin 100 mg or placebo. Randomization of Part
1 and Part 2 will be stratified by T2DM status at baseline.
For both Part 1 and Part 2, the primary endpoint is the change
from baseline in alanine transaminase (ALT) levels at Week 16.
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), serious adverse events (SAEs) and
AEs leading to discontinuation and laboratory abnormalities.
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 T2DM. In preclinical studies,
DA-1241 demonstrated that GPR-119 agonism promotes release of the
key gut peptides GLP-1, GIP, and PYY, which have a beneficial
effect on liver inflammation, lipid metabolism, weight loss, and
glucose metabolism. The therapeutic potential of DA-1241 has been
demonstrated in multiple pre-clinical animal models of NASH and
T2DM whereby DA-1241 reduced hepatic steatosis, hepatic
inflammation, and liver fibrosis, while also improving glucose
control. Furthermore, in Phase 1a and 1b trials, DA-1241 was well tolerated in both
healthy volunteers and those with T2DM.
About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology
company on a quest to transform cardiometabolic diseases. The
company is currently developing DA-1241 for the treatment of
Non-Alcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus
(T2DM), and is developing DA-1726 for the treatment of obesity.
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.
In preclinical studies, DA-1241 demonstrated positive effect on
liver inflammation, lipid metabolism, weight loss, and glucose
metabolism, reducing hepatic steatosis, hepatic inflammation, and
liver fibrosis, while also improving glucose control. DA-1726 is a
novel oxyntomodulin (OXM) analogue that acts as a glucagon-like
peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual
agonist. OXM is a naturally-occurring gut hormone that activates
GLP1R and GCGR, thereby decreasing food intake while increasing
energy expenditure, thus potentially resulting in superior body
weight loss compared to selective GLP1R 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 initiate and
complete clinical trials on a timely basis; 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.