BOSTON, Aug. 3, 2023
/PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq:
NRBO), a clinical-stage biotechnology company on a quest to
transform cardiometabolic diseases, today announced that it has
received the first site Institutional Review Board (IRB) approval
for Zeid Kayali, M.D., Medical
Director at Inland Empire Liver Foundation, in Rialto, CA, to proceed with the Phase 2a
clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119
(GPR119) agonist, for the treatment of nonalcoholic steatohepatitis
(NASH). The dosing of the first patient in part one of the
two-part, Phase 2a clinical trial of DA-1241 is expected to occur
in September of 2023.
"With this first IRB approval, we have achieved another
significant milestone in the clinical development of DA-1241,"
stated Joe Hooker, Interim President
and Chief Executive Officer of NeuroBo. "This promising
cardiometabolic asset has been shown to be well tolerated in both
healthy volunteers and in patients with type 2 diabetes mellitus
(T2DM) in Phase 1a/1b clinical
studies. Additionally, the therapeutic potential of DA-1241 has
been demonstrated in multiple pre-clinical animal models of NASH
and T2DM where DA-1241 reduced hepatic steatosis, inflammation,
fibrosis, and improved glucose control. As a result, we believe
that the mechanism of action of DA-1241 will translate into a safe
and effective treatment for NASH. We look forward to working
closely with our contract research organization (CRO) partner and
our investigators, such as Dr. Kayali, to start screening this
month and expect to dose the first patient in September of this
year. The two-part design provides optionality for an interim
analysis in the first half of 2024 and an anticipated full data
readout in the second half of 2024."
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 a 2:1 ratio
into 2 treatment groups: DA-1241 100 mg/sitagliptin 100 mg or
placebo.
For both Parts 1 and 2, the primary endpoint is the change from
baseline in alanine transaminase (ALT) levels at Week 16. Key,
secondary efficacy endpoints include the proportion of subjects
with normalization of ALT, absolute change in aspartate
transaminase (AST), gamma glutamyl transpeptidase (GGT), and
alkaline phosphatase (ALP) from baseline, and absolute change in
total cholesterol, low- and high-density lipoprotein cholesterol,
triglyceride, and free fatty acids 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 the 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.