Blinded Safety Review Completed for the First
6 Months of the Phase 2a Clinical Trial Conduct; Recommending Trial
Continue Without Modification
Full Data Readout Expected in the Second Half
of 2024
CAMBRIDGE, Mass., March 13,
2024 /PRNewswire/ -- NeuroBo Pharmaceuticals,
Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company
focused on transforming cardiometabolic diseases, today announced
receipt of Safety Review Committee (SRC) approval,
recommending that the two-part Phase 2a trial of DA-1241, a novel
G-Protein-Coupled Receptor 119 (GPR119) agonist for the treatment
of metabolic dysfunction-associated steatohepatitis (MASH),
continue without modification following a blinded safety review of
the first six months of study conduct. The Phase 2a clinical trial
is designed to evaluate the efficacy and safety of DA-1241, for the
treatment of MASH. The company anticipates a full data readout from
the trial in the second half of 2024.
"The SRC's recommendation that the trial continue without
modification based on no findings of significant adverse safety
trends during the first six months of study conduct, is an early
indication of the safety of our most advanced cardiometabolic
asset, DA-1241, for patients with presumed MASH, a disease with no
currently approved treatment options," 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). We continue to believe that the mechanism of
action of DA-1241 will translate into a safe and effective
treatment for MASH and look forward to another blinded SRC analysis
once the first 50% of patients have been randomized and dosed."
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. Part
1 is exploring 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, which 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, triglycerides, 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.
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 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
Chief Financial Officer
+1-857-299-1033
marshall.woodworth@neurobopharma.com
Rx Communications Group
Michael
Miller
+1-917-633-6086
mmiller@rxir.com
View original
content:https://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-receives-safety-review-committee-approval-to-continue-with-its-phase-2a-clinical-trial-evaluating-da-1241-for-the-treatment-of-mash-302087594.html
SOURCE NeuroBo Pharmaceuticals, Inc.