Topline Data Readout From Part 1 and Part 2
Expected in December 2024
CAMBRIDGE, Mass., Nov. 4, 2024
/PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq:
NRBO), a clinical-stage biotechnology company focused on
transforming cardiometabolic diseases, today announced the
completion of the last patient last visit in its two-part, Phase 2a
clinical trial evaluating the efficacy and safety of DA-1241, a
novel G-Protein-Coupled Receptor 119 (GPR119) agonist for the
treatment of metabolic dysfunction-associated steatohepatitis
(MASH).
"Completion of patient dosing in the Phase 2a clinical trial of
DA-1241, in patients with presumed MASH, marks an important
milestone for this promising cardiometabolic asset, bringing us one
step closer to the topline data readout from both Part 1 and Part 2
of the Phase 2a clinical trial expected in December of this year,"
stated Hyung Heon Kim, President and
Chief Executive Officer of NeuroBo. "As a reminder, Part 1 of this
Phase 2a trial is exploring DA-1241 compared to placebo, while Part
2 is investigating the efficacy of DA-1241 in combination with
sitagliptin, a DPP-4 inhibitor, which we believe will show
synergistic effects compared to DA-1241, alone. In a
previously reported Phase 1 study, DA-1241 was well tolerated in
both healthy volunteers and individuals diagnosed with type 2
diabetes mellitus (T2DM). Based on the pre-clinical and clinical
evidence, we maintain our belief that the distinctive mechanism of
action DA-1241, which addresses the inflammation linked to MASH,
will result in a safe and effective therapeutic option for this
disease."
Each of the two parts of the Phase 2a trial of DA-1241 are
designed to be 16-week, multicenter, randomized, double-blind,
placebo-controlled, parallel clinical studies to evaluate the
efficacy and safety of DA-1241 in subjects with presumed MASH. A
total of 109 patients were randomized, while 95 patients completed
the dosing. These patients were enrolled in either Part 1, which is
exploring the efficacy of DA-1241 versus placebo, and randomized in
a 1:2:1 ratio into 3 treatment groups: DA-1241 50 mg, DA-1241 100
mg or placebo, or into Part 2, which is exploring the efficacy of
DA-1241 in combination with sitagliptin versus placebo, 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, triglycerides, and
free fatty acids from baseline, among others. Safety will be
evaluated by monitoring adverse events (AEs) and serious adverse
events (SAEs) leading to discontinuation and laboratory
abnormalities.
For more information on this clinical trial, please visit:
www.clinicaltrials.gov NCT06054815.
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 type 2 diabetes (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
MASH and T2D where DA-1241 reduced hepatic steatosis, inflammation,
fibrosis, and improved 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-1726 for the treatment of
obesity, and is developing DA-1241 for the treatment of Metabolic
Dysfunction-Associated Steatohepatitis (MASH). 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. 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
pre-clinical 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.
For more information, please visit www.neurobopharma.com.
Forward Looking Statements
Certain statements in this press 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", "potential", "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 press release, including,
without limitation, those risks associated with NeuroBo's ability
to execute on its commercial strategy; the timeline for regulatory
submissions; the 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
NeuroBo's contract manufacturers, clinical study partners and
others involved in the development of NeuroBo's current and future
product candidates; potential negative interactions between
NeuroBo's 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; NeuroBo's 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; the effects of changes in applicable laws or
regulations; the 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 NeuroBo's filings with
the Securities and Exchange Commission, including NeuroBo's most
recent Annual Report on Form 10-K. 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, Inc.
Marshall H. Woodworth
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.
