BOSTON, Oct. 13, 2021 /PRNewswire/ -- NeuroBo
Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage
biotechnology company focused on developing and commercializing
multimodal disease-modifying therapies for viral, neuropathic and
neurodegenerative diseases, today announced that an independent
Data Monitoring Committee (DMC) reviewed safety data from 36
patients treated in the Phase 2/3 clinical trial of NeuroBo's lead
drug candidate, ANA001, a proprietary oral niclosamide formulation
being developed as a potential treatment for COVID-19. Based on
those findings, the DMC recommended the continuation of the trial
without modification.
The two-part Phase 2/3 multi-center, double blind,
placebo-controlled study to assess safety, tolerability, and
efficacy of ANA001 is being conducted in the U.S. In both phases of
the study, hospitalized patients with moderate to severe COVID-19
(patients not requiring ventilators) receive a seven-day course of
ANA001 (niclosamide capsules) in addition to standard-of-care
treatment. The Phase 2 part of the trial is expected to enroll 60
patients and the primary objective is to assess safety and
tolerability. Secondary objectives include measurements of efficacy
(median time to hospital discharge) and pharmacokinetics (PK).
The Phase 3 part of the trial is expected to enroll several
hundred patients, with the primary endpoints being median time to
hospital discharge, safety and tolerability. Secondary objectives
will evaluate clinical improvement and the need and duration for
rescue therapy.
"The DMC's recommendation to continue enrollment of the Phase
2/3 clinical trial, without modification, is an important milestone
for our lead drug candidate, ANA001, as a potential treatment for
COVID-19," stated Richard J. Kang,
Ph.D., President and Chief Executive Officer of NeuroBo. "We look
forward to continuing the development of this potentially
life-saving therapy to address the ongoing need for safe and
effective COVID-19 treatments, particularly as this pandemic is
evolving into an endemic. We expect to complete the Phase 2 portion
of the trial in the fourth quarter of this year and to achieve a
number of value-creating milestones with this program in the coming
months, including initiation of the Phase 3 of trial."
For more information on this clinical trial, please visit:
www.clinicaltrials.gov, NCT04603924
About Niclosamide and ANA001
ANA001 is a proprietary oral niclosamide formulation in
development as a treatment for patients with COVID-19. Niclosamide
has antiviral and anti-inflammatory properties, and a
well-understood safety profile in humans. ANA001 is currently being
studied in a 60-subject Phase 2 clinical trial conducted 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.
Additional in vitro 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 against a variety 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
pulmonary and/or cardiovascular conditions.
As a result, the company believes ANA001 has the potential to
reduce viral load and inflammation associated with cytokine
dysregulation, acute respiratory distress syndrome (ARDS), and
coagulation abnormalities and thus improve time to clinical
improvement 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
COVID-19; (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 COVID-19. Niclosamide has antiviral and
anti-inflammatory properties, and a well-understood safety profile
in humans. ANA001 is currently being studied in a 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 the global COVID-19 crisis, a planned Phase 3
study of NB-01 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 previously being 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
COVID-19.
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 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 ANA 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; NeuroBo's plans to research, develop and
commercialize its current and future product candidates, including
the potential alternative pathways for NB-01; NeuroBo's ability to
successfully collaborate with existing collaborators or enter into
new collaborations and to fulfill its obligations under any such
collaboration agreements; the clinical utility, potential benefits
and market acceptance of NeuroBo's product candidates, including
ANA001 and Gemcabene; the impact of government laws and
regulations; NeuroBo's ability to protect its intellectual property
position; 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 filed with the
Securities and Exchange Commission on or about the date hereof. 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.
Contact:
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
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SOURCE NeuroBo Pharmaceuticals, Inc.