BOSTON, Aug. 2, 2023
/PRNewswire/ -- NeuroBo Pharmaceuticals,
Inc. (Nasdaq: NRBO), a clinical-stage biotechnology
company on a quest to transform cardiometabolic diseases, today
announced that it has entered into a term sheet with MThera Pharma
Co., Ltd. (MTHERA) which provides for the terms under which NeuroBo
will out-license the worldwide rights, outside of Korea, for NB-01
for the treatment of painful diabetic neuropathy to MTHERA. The
term sheet allows MTHERA to conduct research in order to seek new
patents for NB-01 and conduct clinical trials, including, but not
limited to, a potential Phase 3 clinical trial in the United States for the future
commercialization of NB-01. The financial terms of the term sheet,
which are binding, were not disclosed.
"We believe that MTHERA's extensive experience in manufacturing,
quality control and clinical development of natural medicines and
botanical drugs makes it the perfect partner to continue the
development of NB-01, "stated Joseph
Hooker, Interim President and Chief Executive Officer of
NeuroBo. "Since acquiring the cardiometabolic assets DA-1241 and
DA-1726, we have focused diligently to evaluate potential
out-licensing and acquisition opportunities for our four legacy
therapeutic programs, ANA001, NB-01, NB-02 and Gemcabene, and this
term sheet with MTHERA is a testament to those efforts. We look
forward to working with MTHERA to assist them in manufacturing
NB-01 for potential clinical trials and to facilitate discussions
with contract manufacturing companies including our partner, Dong-A
ST, Co. Ltd."
"We are grateful to NeuroBo and Dong-A ST for the opportunity to
participate in the research and development of NB-01," stated Dr.
Mi Won Sohn, Chief Executive Officer
of MTHERA. "NB-01, as a drug candidate for diabetic neuropathy, has
obtained excellent efficacy results in a phase 2 trial in the U.S.,
and we anticipate developing it as a potential treatment for
peripheral diabetes. Utilizing MTHERA's platform technology,
SyMthomics, the mechanism of action and active ingredients of NB-01
will be thoroughly identified to help predict clinical efficacy as
an innovative treatment with the intent of advancing NB-01 into the
next phase of clinical development."
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 on a quest to transform cardiometabolic diseases. The
company is currently developing DA-1241 for the treatment of
Non-Alcoholic Steatohepatitis (NASH) 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,
which promotes the release of key gut peptides GLP-1, GIP, and PYY.
In preclinical studies, DA-1241 demonstrated 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 acts 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
Any statements in this press release that are not statements of
historical fact constitute forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. These statements include, but are not limited to,
statements regarding the development of NeuroBo's product
candidates and the therapeutic potential, timing and nature of
clinical trials and potential regulatory approval of NeuroBo's
clinical programs and pipeline. Forward-looking statements are
usually identified by the use of words, such as "believes,"
"anticipates," "expects," "intends," "plans," "may," "potential,"
"will," "could" and similar expressions. Actual results may differ
materially from those indicated by forward-looking statements as a
result of various important factors and risks. 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 advancement of NeuroBo's
drug development pipeline, in particular through clinical
development, NeuroBo's ability to follow the timeline for
regulatory submissions and obtain regulatory approvals with respect
to the development and commercialization of NeuroBo's current and
future product candidates, the ability to realize the benefits of
the license agreement with Dong-A, including the impact on future
financial and operating results of NeuroBo; the ability to
integrate the new product candidates into NeuroBo's business in a
timely and cost-efficient manner; the cooperation of NeuroBo's
contract manufacturers, clinical study partners and others involved
in the development of NeuroBo's current and future product
candidates; costs related to the license agreement, known and
unknown, including costs of any litigation or regulatory actions
relating to the license agreement; 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; the
ability of NeuroBo to successfully out-license or sell the assets
associated with its legacy therapeutic programs; the ability of
NeuroBo to benefit from any such out-license or sale of such
assets; and other risks and uncertainties described in NeuroBo's
filings with the SEC; and other factors discussed in the "Risk
Factors" section of NeuroBo's Annual Report on Form 10-K filed with
the Securities and Exchange Commission on March 30, 2023. In addition, the forward-looking
statements included in this press release represent NeuroBo's views
as of the date hereof. NeuroBo anticipates that subsequent events
and developments will cause its views to change. However, while
NeuroBo may elect to update these forward-looking statements at
some point in the future, NeuroBo specifically disclaims any
obligation to do so. These forward-looking statements should not be
relied upon as representing NeuroBo's views as of any date
subsequent to the date hereof.
Contacts
Investors & Media:
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
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SOURCE NeuroBo Pharmaceuticals, Inc.