BOSTON, March 24, 2021 /PRNewswire/ -- NeuroBo
Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage
biotechnology company, today announced that it has received
approval of an amendment to its Contingent Value Rights (CVR)
agreement from a majority of the holders of a majority of the
outstanding CVRs, incentivizing the evaluation of Gemcabene as a
treatment for COVID-19.
The CVRs were distributed to the holders of Gemphire
Therapeutics, Inc. common stock on December
30, 2019, immediately prior to its merger with NeuroBo
Pharmaceuticals, Inc. The CVR amendment will allow NeuroBo to
pursue Gemcabene as a therapy for COVID-19, with its own resources.
In exchange, CVR holders will receive 10% of certain gross proceeds
received by the company for any indication outside of treating
cardiometabolic diseases. CVR holders will retain the original CVR
for 80% of any proceeds of Gemcabene for cardiovascular conditions.
"The amendment to the CVR agreement represents another important
milestone for NeuroBo and underscores investors' enthusiasm to
explore additional therapeutic indications for Gemcabene that may
strengthen our pipeline of assets to treat viral diseases including
COVID-19," stated Richard J. Kang,
Ph.D., President and Chief Executive Officer of NeuroBo. "We intend
to evaluate Gemcabene both as a stand-alone treatment for COVID-19,
and in a treatment combination with ANA001, our proprietary oral
niclosamide formulation, which is currently in a 60-patient phase
2/3 trial as a treatment for moderate to severe COVID-19. We expect
data from the Phase 2 segment of the ANA001 study in the third
quarter of 2021 and are currently pursuing an abbreviated 505(b)(2)
regulatory pathway.
Dr. Kang continued, "Even with the development of COVID-19
vaccines, current and future variants of the virus will likely
necessitate a toolbox of effective therapies to treat various
patient populations suffering from COVID-19. We look forward to
achieving multiple value-creating milestones in the coming year,
including the data monitoring committee results, the
pharmacokinetic (PK) data for the phase 2 trial of ANA001, the
top-line data readout from the phase 2 trial of ANA001 to treat
COVID-19 and preclinical in vitro data for Gemcabene against
COVID-19 variants alone and in treatment combination with ANA001.
We are excited to continue the development of these potentially
life-saving therapies to address the ongoing need for safe and
effective COVID-19 treatments on a global scale."
About Gemcabene
Gemcabene, a peroxisome proliferation-activated receptor (PPARα)
agonist, is a novel, once daily, oral therapy, for patients who are
unable to achieve normal levels of LDL C or triglycerides with
currently approved therapies, primarily statin therapy. Gemcabene's
mechanism of action is designed to enhance the clearance of very
low-density lipoproteins (VLDLs) in the plasma and inhibit the
production of fatty acids and cholesterol in the liver.
Gemcabene was being evaluated in a Phase 2 randomized,
double-blind, placebo-controlled study to assess its efficacy
safety and tolerability in patients with severe
hypertriglyceridemia. In January
2016, the Gemcabene Phase 2 clinical study was placed on
partial clinical hold as the U.S. Food and Drug Administration
requested 2-year rat and mouse carcinogenicity studies to be
completed and submitted. The study currently remains on partial
clinical hold for the treatment of dyslipidemia. Gemcabene is
currently being assessed as an acute treatment for COVID-19.
About Niclosamide and ANA001
ANA001 is a proprietary oral niclosamide formulation in
development as a treatment for patients with moderate to severe
COVID-19 (patients not requiring ventilators). Niclosamide is a
potential oral antiviral and anti-inflammatory agent with a long
history of use and a well-understood safety profile in humans.
ANA001 is currently being studied in a 60-subject Phase 2/3
clinical trial conducted at up to 20 clinical sites in the U.S.
Niclosamide has demonstrated both antiviral and immunomodulatory
activity with possible downstream effects on coagulation
abnormalities observed in COVID-19. In preclinical research by an
independent academic group published in Antimicrobial Agents and
Chemotherapy, niclosamide inhibited viral replication in
vitro and was more potent than remdesivir in the same
assay.
Specifically, studies have shown that niclosamide prevents
replication of SARS-CoV-2 at very low concentrations and that the
compound appears to exhibit three distinct mechanisms of action: 1)
acting as a potent antiviral to a broad homology of other viruses
including influenza; 2) reducing inflammation without suppressing
the immune system; and 3) providing bronchodilation, which is a
useful pulmonary mechanism for at-risk patients with
underlying cardiovascular and/or pulmonary conditions.
As a result, the company believes ANA001 has the potential to
reduce the viral load and inflammation associated with cytokine
dysregulation, acute respiratory distress syndrome (ARDS), and
coagulation abnormalities and thus improve time to clinical
improvement as defined as hospital discharge recorded using the WHO
Ordinal Scale for Clinical Improvement.
The company believes ANA001 has distinct competitive advantages
in this market, including (1) offering an effective treatment for
moderate to severe COVID-19 (patients not requiring ventilators);
(2) having 3+ year marketing exclusivity in the U.S. upon U.S. Food
and Drug Administration (FDA) approval; (3) providing ease of
administration via a capsule formulation and potential to
dramatically lower overall treatment cost; and (4) possessing a
proven safety profile (generic niclosamide has been used safely for
50 years as a treatment for tapeworm infections).
About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology
company focused on developing and commercializing multi-modal
disease-modifying therapies for viral, neuropathic, and
neurodegenerative diseases, has a current portfolio of four
drug candidates. The company's recently acquired ANA001 candidate
is a proprietary oral niclosamide formulation in development as a
treatment for patients with moderate to severe COVID-19 (patients
not requiring ventilators). Niclosamide is a potential oral
antiviral and anti-inflammatory agent with a long history of use
and a well-understood safety profile in humans. ANA001 is currently
being studied in a 60-subject Phase 2/3 clinical trial conducted at
up to 20 clinical sites in the U.S. Niclosamide has demonstrated
both antiviral and immunomodulatory activity with possible
downstream effects on coagulation abnormalities observed in
COVID-19. The company's NB-01 candidate has been shown in a Phase 2
study to significantly reduce pain symptoms associated with painful
diabetic neuropathy (PDN), with a superior safety profile when
compared to currently available treatments. Due to global COVID-19
crisis, a planned Phase 3 study was postponed. In the interim,
NeuroBo is exploring a potential orphan drug indication targeting
chronic pain for NB-01. NeuroBo's NB-02 drug candidate 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's fourth program, Gemcabene, was
developed for the treatment of dyslipidemia, a serious medical
condition that increases the risk of life-threatening
cardiovascular disease. Gemcabene is currently being assessed as an
acute treatment for SAR-CoV-2.
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 timeline for niclosamide for
the treatment of COVID-19, the market size for COVID-19-related
therapeutics and the competitive advantages of ANA001, the
potential benefits of ANA001 as a treatment for patients with
moderate to severe COVID-19 (patients not requiring ventilators),
the potential distribution of proceeds to CVR holders, and the
timing or receipt of regulatory approvals. 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 failure to obtain all of the benefits or
recognize all of the synergies anticipated from the ANA
acquisition; the integration of ANA potentially diverting
management resources from operational matters and other strategic
opportunities; the effect of future milestone payments and
royalties specified in the acquisition agreement on the results of
operations and financial position of NeuroBo; the occurrence of
health epidemics or contagious diseases, such as COVID-19, and
potential effects on NeuroBo's business, clinical trial sites,
supply chain and manufacturing facilities; NeuroBo's ability to
continue as a going concern; the timing of completion of NeuroBo's
planned clinical trials, including with respect to ANA001 and
Gemcabene; the timing of the availability of data from NeuroBo's
clinical trials, including with respect to ANA001 and
Gemcabene; the clinical utility, potential benefits and
market acceptance of NeuroBo's product candidates, including ANA001
and Gemcabene; and NeuroBo's need for additional financing to
fulfill its stated goals; and other 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.