Two-Part Design Provides Optionality for
Interim Analysis in First Half of 2024
Full Data Readout Expected in the Second Half
of 2024
BOSTON, Sept. 15,
2023 /PRNewswire/ -- NeuroBo Pharmaceuticals,
Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company on
a quest to transform cardiometabolic diseases, today announced
dosing of the first patient in its two-part, Phase 2a clinical
trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119)
agonist, for the treatment of nonalcoholic steatohepatitis
(NASH), at The Pinnacle
Edinberg/South Texas Research Institute in Edinburg, Texas, under the supervision of
Principal Investigator, Dr. David
Ramirez.
"Dosing the first patient, on time, is a testament to our
commitment to the clinical development of DA-1241 in patients with
NASH," stated Hyung Heon Kim, President and Chief Executive
Officer of NeuroBo. "Based on the pre-clinical and clinical
evidence generated to date, DA-1241 has demonstrated reduced
hepatic steatosis, hepatic inflammation, and liver fibrosis, while
also improving glucose control, and was shown to be well tolerated
in both healthy volunteers and in patients with type 2 diabetes
mellitus (T2DM). Given this data, we believe that the mechanism of
action of this promising cardiometabolic asset will translate into
a safe and effective treatment for NASH, a disease with no current treatment
options. The two-part design of this trial provides optionality for
a potential interim analysis in the first half of 2024 and we
expect to report the full data in the second half of 2024."
Each of the two-parts of the 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.
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, 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; receiving
results from our clinical trials that are consistent with the
results of pre-clinical and previous 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
View original
content:https://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-doses-first-patient-in-its-phase-2a-clinical-trial-evaluating-da-1241-for-the-treatment-of-nash-301928850.html
SOURCE NeuroBo Pharmaceuticals, Inc.