Phase 1 Clinical Trial Timelines Significantly
Accelerated
Top-Line Data Readout from Single Ascending
Dose Part 1 Now Expected in the Third Quarter of 2024
First Patient Dosed in the Multiple Ascending
Dose Part 2 Expected in the Third Quarter of 2024
CAMBRIDGE, Mass., April 17,
2024 /PRNewswire/ -- NeuroBo Pharmaceuticals,
Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company
focused on transforming cardiometabolic diseases, today announced
dosing of the first patient in the single ascending dose (SAD) Part
1 of its two-part Phase 1 clinical trial of DA-1726, a novel, dual
oxyntomodulin (OXM) analog agonist that functions as a
glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor
(GCGR), for the treatment of obesity.
"Dosing of the first patient in this trial is a groundbreaking
achievement in the development of DA-1726, marking the first time
this cardiometabolic asset will be tested in humans, bringing it
one step closer to treating obesity, utilizing a novel mechanism as
compared to other currently available treatments," stated
Hyung Heon Kim, President and Chief
Executive Officer of NeuroBo. "Although the main goal of the SAD
part of this study is to assess the safety and tolerability of
DA-1726, based on pre-clinical evidence, we believe that it may
have a better tolerability profile than currently available GLP-1
agonists due to its balanced activation of GLP1R and glucagon
receptors, reducing food intake while also increasing energy
expenditure. Specifically, in pre-clinical mouse models, DA-1726
showed superior weight loss compared to semaglutide (Wegovy®) and
resulted in similar weight reduction while consuming more food
compared to tirzepatide (Zepbound™). Notably, we have significantly
accelerated the timelines for the Phase 1 trial, and look forward
to dosing the first patient in the multiple ascending dose (MAD)
Part 2 in the third quarter of this year. Additionally, we now
expect to report top-line data from the SAD Part 1 in the third
quarter of 2024, and the MAD Part 2 in the first quarter of
2025."
The Phase 1 trial is designed to be a randomized,
placebo-controlled, double-blind, two-part study to investigate the
safety, tolerability, pharmacokinetics (PK), and pharmacodynamics
(PD) of single and multiple ascending doses of DA-1726 in obese,
otherwise healthy subjects. The Part 1 SAD study is expected to
enroll approximately 45 participants, randomized into one of 5
planned cohorts. Each cohort will be randomized in a 6:3 ratio of
DA-1726 or placebo. Part 2 is designed as a MAD study, expected to
enroll approximately 36 participants, who will be randomized at the
same 6:3 ratio into 4 planned cohorts, each to receive 4 weekly
administrations of DA-1726 or placebo.
The primary endpoint will assess the safety and tolerability of
DA-1726 by monitoring adverse events (AEs), serious adverse events
(SAEs), treatment emergent adverse events (TEAEs) and AEs leading
to treatment discontinuation. Secondary endpoints include the PK of
DA-1726, assessed via serum concentrations over time and metabolite
profiling at the highest doses of DA-1726. Exploratory endpoints
will include the effect of DA-1726 on metabolic parameters, cardiac
parameters, fasting lipid levels, body weight, waist circumference
and body mass index (BMI), among others.
For more information on this clinical trial, please visit:
www.clinicaltrials.gov NCT06252220.
About DA-1726
DA-1726 is a novel oxyntomodulin (OXM)
analogue functioning as a GLP1R/GCGR dual agonist for the treatment
of obesity and MASH that is to be administered once weekly
subcutaneously. DA-1726 acts as a dual agonist of GLP-1 receptors
(GLP1R) and glucagon receptors (GCGR), leading to weight loss
through reduced appetite and increased energy expenditure. DA-1726
has a well understood mechanism and, in preclinical mice models,
resulted in improved weight loss compared to semaglutide and
cotadutide (another OXM analogue).
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; 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; 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; 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 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
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SOURCE NeuroBo Pharmaceuticals, Inc.