Full Data Readout Expected in the Second Half
of 2024
CAMBRIDGE, Mass., Jan. 18,
2024 /PRNewswire/ -- NeuroBo Pharmaceuticals,
Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company
focused on transforming cardiometabolic diseases, today announced
positive pre-clinical safety data of DA-1241, a novel
G-Protein-Coupled Receptor 119 (GPR119) agonist, in combination
with sitagliptin, a DPP4 inhibitor. Additionally, having satisfied
its 45-day commitment with the U.S. Food and Drug Administration
(FDA) related to its amended protocol, the company has opened
enrollment for Part 2 of its Phase 2a clinical trial of DA-1241
when co-administered with sitagliptin for the treatment of
metabolic dysfunction-associated steatohepatitis (MASH).
The pre-clinical results demonstrated that once daily oral
administration in rats, of sitagliptin alone (180 mg/kg/day),
DA-1241 alone (100 mg/kg/day), or sitagliptin in combination with
DA-1241 (up to 180/100 mg/kg/day sitagliptin+DA-1241) for 13 weeks,
was well tolerated with no adverse effects.
"Initiating Part 2 of our clinical study of DA-1241 in MASH
patients paves the way to begin dosing in combination with
sitagliptin, marking another significant clinical milestone for our
most advanced asset," stated Hyung Heon
Kim, President and Chief Executive Officer of NeuroBo.
"Based on the pre-clinical evidence to date, DA-1241 has been shown
to improve both hepatic and systemic inflammation effectively, and
the combination with sitagliptin increased the anti-inflammatory
effects compared to DA-1241 as a monotherapy. As previously
reported, DA-1241 was also well tolerated in healthy volunteers and
in patients with type 2 diabetes mellitus (T2DM). Given the
totality of this data, we believe that the mechanism of action
could allow DA-1241 to become a safe and effective treatment for
MASH, and its anti-MASH and anti-diabetic effects could be
potentiated when co-administered with a DPP4 inhibitor. We expect
to report the full data from the Part 2 trial 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 MASH. Part
1, currently dosing subjects, is exploring the efficacy of DA-1241
versus placebo, and is expected to enroll approximately 49
subjects, who 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, is expected to enroll approximately 37
subjects, who will be randomized in a 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 MASH 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 MASH 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 focused on
transforming cardiometabolic diseases. The company is currently
developing DA-1241 for the treatment of Metabolic
Dysfunction-Associated Steatohepatitis (MASH) 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 that promotes the release of key gut peptides GLP-1, GIP,
and PYY. In preclinical studies, DA-1241 demonstrated a 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
functions 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.
Words such as "believes", "expects", "anticipates", "may", "will",
"should", "seeks", "approximately", "intends", "projects," "plans",
"estimates" or the negative of these words or other comparable
terminology (as well as other words or expressions referencing
future events, conditions or circumstances) are intended to
identify forward-looking statements. 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 NeuroBo's ability to
execute on its commercial strategy; the timeline for regulatory
submissions; ability to obtain regulatory approval through the
development steps of NeuroBo's 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 cooperation of our
contract manufacturers, clinical study partners and others involved
in the development of NeuroBo's current and future product
candidates; potential negative interactions between our product
candidates and any other products with which they are combined for
treatment; NeuroBo's ability to initiate and complete clinical
trials on a timely basis; our ability to recruit subjects for its
clinical trials; whether NeuroBo receives results from NeuroBo's
clinical trials that are consistent with the results of
pre-clinical and previous clinical trials; impact of costs related
to the license agreement, known and unknown, including costs of any
litigation or regulatory actions relating to the license agreement;
effects of 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, except as required by
law.
Contacts:
NeuroBo Pharmaceuticals
Marshall H. Woodworth
Interim Chief Financial Officer
+1-857-299-1033
marshall.woodworth@neurobopharma.com
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
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SOURCE NeuroBo Pharmaceuticals, Inc.