CAMBRIDGE, Mass., July 30,
2024 /PRNewswire/ -- NeuroBo Pharmaceuticals,
Inc. (Nasdaq: NRBO), a clinical-stage biotechnology
company focused on the transformation of cardiometabolic diseases,
today announced the signing of an exclusive license agreement,
providing MThera Pharma Co., Ltd. (MTHERA) with the rights to NB-01
for the treatment of painful diabetic neuropathy. The agreement
allows MTHERA to conduct research and clinical trials,
including, but not limited to, a potential Phase 3 clinical trial
in the United States and South
Korea, for the future commercialization of NB-01. Financial
terms of the agreement were not disclosed.
"Finalizing this agreement for NB-01 is an important milestone
for NeuroBo, reflecting our stated commitment to out-license our
legacy assets in order to focus on the continued clinical
development of DA-1726 and DA-1241," stated Hyung Heon Kim, President and Chief Executive
Officer of NeuroBo. "MTHERA has extensive experience in
manufacturing, quality control and clinical development of natural
medicines and botanical drugs, making the company an ideal partner
to continue the development of NB-01."
"Based on the positive Phase 2 efficacy results for NB-01 for
diabetic neuropathy, we intend to develop it as a potential
treatment for peripheral diabetes," stated Dr. Mi Won Sohn, Chief Executive Officer of MTHERA.
"Utilizing our SyMthomics platform technology, we can clearly
identify the mechanism of action and active ingredients of NB-01 to
assist in predicting its clinical efficacy as an innovative
treatment, with the intent of advancing NB-01 into the next phase
of clinical development. We are grateful to NeuroBo for the
opportunity to further advance NB-01, and to potentially bring this
promising therapy to patients in need."
About MThera Pharma
MThera Pharma Co., Ltd.,
headquartered in Seoul, South
Korea, is a biopharmaceutical company developing
first-in-class botanical drug products using novel,
multi-component/multi-target-driven disease-modifying therapies to
address diverse etiology and treat chronic incurable diseases such
as Parkinson's disease, dementia and inflammatory bowel disease.
MThera's platform technology, SyMthomics, consists of its
MThera-CODA system (AI based in silico system), a cutting-edge
multi-omics integration technology, as well as systems biology and
bioinformatics. MThera's standardization technology and advanced
CMC technology for raw materials, drug substances and drug products
are designed to meet the U.S. Food and Drug Administration
requirements for therapeutic consistency. For more information,
please visit www.mtherapharma.com.
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", "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
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.