BOSTON, May 26, 2020 /PRNewswire/ -- NeuroBo
Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage
biotechnology company focused on developing and commercializing
multimodal, disease-modifying therapies for neurodegenerative and
cardiometabolic diseases, today announced that it received written
communication from the U.S. Food and Drug Administration (FDA) that
the clinical development program for Gemcabene, a peroxisome
proliferation-activated receptor (PPARα) agonist, under
development as a once-daily, oral therapy for the treatment of
dyslipidemia, remains on partial clinical
hold. In January 2016, the Gemcabene Phase 2 clinical
study was placed on partial clinical hold as the FDA requested
2-year rat and mouse carcinogenicity studies to be completed and
submitted.
In May 2018, the company submitted
the requested data to the FDA, which the Agency determined was
insufficient to lift the partial clinical hold at that time. On
April 20, 2020, the company filed an
amendment to the FDA's partial clinical hold letter received in
June 2018.
"While we are disappointed that the partial clinical hold
was not lifted at this time, we plan to request additional
clarification regarding the resolution options the FDA suggest in
their response letter, in order to better evaluate a path
forward for Gemcabene as a treatment for dyslipidemia," said
Richard J. Kang, Ph.D., President
and Chief Executive Officer of NeuroBo.
About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals,
Inc. is focused on novel treatments for neurodegenerative and
cardiometabolic diseases affecting millions of patients worldwide.
The company's multimodal approach has the potential to address
multiple underlying mechanisms of neurodegenerative diseases,
alleviate symptoms and slow disease progression. The company's drug
candidate, NB-01, for the treatment of painful diabetic neuropathy
(PDN), has been shown in a Phase 2 study to significantly reduce
pain symptoms associated with PDN with a superior safety profile
when compared to currently available treatments. Due to the global
COVID-19 crisis, a planned Phase 3 study is currently postponed. In
the interim, NeuroBo is exploring a potential orphan drug
indication and/or a nutraceutical pathway targeting chronic pain
for NB-01. NeuroBo's drug candidate, NB-02, is focused on the
treatment of Alzheimer's disease and neurodegenerative diseases
associated with the pathological dysfunction of tau proteins in the
brain. The company is also exploring an orphan drug pathway for
NB-02. The company's third program, Gemcabene, is focused on
developing and commercializing therapies for the treatment of
dyslipidemia, a serious medical condition that increases the risk
of life-threatening cardiovascular disease.
NeuroBo Pharmaceuticals was jointly founded by Dr. Roy
Freeman, professor of neurology at Harvard Medical
School and renowned expert in neuropathic pain, and JK
BioPharma Solutions, a biotechnology consulting company, to
commercialize natural product-based research into ethical
medicines. In December 2019, NeuroBo
merged with Gemphire Therapeutics and through such merger, became
listed on the Nasdaq Stock Market and added the Gemcabene family of
related assets to its portfolio. For more information
visit: https://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. These factors, risks and uncertainties
include, but are not limited to the factors discussed in the "Risk
Factors" section of NeuroBo's Annual Report on Form 10-K and in our
other filings with the Securities and Exchange Commission. 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:
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
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SOURCE NeuroBo Pharmaceuticals, Inc.