BOSTON, Jan. 6, 2021 /PRNewswire/ -- NeuroBo
Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage
biotechnology company, today announced that on December 31, 2020 it acquired ANA Therapeutics, a
privately held biotechnology company developing ANA-001, a
proprietary capsule formulation of niclosamide for coronavirus
indications, currently in Phase 2/3 clinical trials as a treatment
for COVID-19. The transaction was unanimously approved by both the
NeuroBo Pharmaceuticals' and ANA Therapeutics' Boards of
Directors.
"This is an exciting and transformative acquisition for NeuroBo
that expands our pipeline with a late-stage clinical development
program that addresses the urgent need for new treatments to
address COVID-19, a highly-infectious and often deadly virus,"
stated Richard J. Kang, Ph.D., President and Chief Executive
Officer of NeuroBo. "ANA-001 is advancing through the 505(b)(2)
clinical pathway, which allows us to leverage earlier data on
niclosamide and streamlines and accelerates the timelines to bring
this potentially life-saving therapy to patients suffering with
COVID-19. As a result, the development timeline supports a number
of value-creating milestones over the coming 12 to 18 months,
including the data readout of the Phase 2 portion of the trial,
expected in the third quarter of 2021."
"While the introduction of vaccines is expected to play a
significant role in stemming the tide of the COVID-19 pandemic, the
ongoing complexities and mutation of the disease will require
therapies to treat the infected population for the foreseeable
future," commented Irene Kim, Chair
of the Board of NeuroBo. "Similar to influenza, taking a
COVID-19 vaccine and therapy could become an annual routine.
Preclinical data has demonstrated niclosamide's ability to inhibit
viral replication of SARS-CoV-2 and underscores ANA-001's potential
to effectively address the ongoing need for safe and effective
COVID-19 treatments on a global scale."
"We are delighted to join with the NeuroBo team in order to
bring ANA-001 to the millions of patients infected with COVID-19.
NeuroBo has the leadership and platform to support the accelerated
development of this important compound as a potential treatment for
this viral pandemic," said Akash
Bakshi, Chief Executive Officer of ANA
Therapeutics.
About Niclosamide and ANA-001
ANA-001 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.
ANA-001 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 ANA-001 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 ANA-001 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).
Clinical Development Plans for ANA-001
In October 2020, a Phase 2/3
clinical trial evaluating ANA-001 as a treatment for COVID-19 was
initiated. The two-part Phase 2/3 multi-center, double blind,
placebo-controlled study to assess the safety, tolerability, and
efficacy of ANA-001 is being conducted at up to 20 clinical sites
in the U.S. In both phases of the study, hospitalized patients with
moderate to severe COVID-19 (patients not requiring ventilators)
will be administered a seven-day course of ANA-001 (niclosamide
capsules) in addition to standard-of-care treatment. The first
phase of the trial will enroll 60 patients. The primary objective
of the first phase of the trial is to assess safety and
tolerability; secondary objectives include measurements of efficacy
(median time to hospital discharge) and pharmacokinetics. The
company expects to complete enrollment of the first phase of the
study and to have topline data from this segment of the trial in
the third quarter of 2021.
The second phase of the trial is expected to enroll several
hundred patients, with the primary endpoints of the study being
median time to hospital discharge, safety and tolerability.
Secondary objectives will evaluate clinical improvement and the
need and duration for rescue therapy.
For more information on this clinical trial, please
visit: www.clinicaltrials.gov, NCT04603924.
Acquisition Details
Under the terms of the acquisition agreement, ANA became a
wholly-owned subsidiary of NeuroBo and ANA equity holders were
issued an aggregate of approximately 3.24 million shares of Neurobo
common stock, representing 19.7% of NeuroBo's outstanding shares.
ANA shareholders will receive additional payments (in cash or
NeuroBo common shares) upon the achievement of various development
and net sales milestones for ANA-001 and will also receive
royalties based on net sales of ANA-001.
Three key executives from ANA Therapeutics have joined the
NeuroBo management team including, Akash
Bakshi, as Senior Vice President and Chief Operating
Officer, Nadja Mannowetz, Ph.D., as
Senior Vice President, and Andrew
Bartynski, Ph.D., as Senior Vice President. In addition, Mr.
Bakshi has joined NeuroBo's board of directors.
About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology
company focused on developing and commercializing multimodal,
disease-modifying therapies for neurodegenerative and
cardiometabolic diseases, has a current portfolio of four drug
candidates. The company's recently acquired ANA-001 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. ANA-001 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 third
program, Gemcabene, was developed for the treatment of
dyslipidemia, a serious medical condition that increases the risk
of life-threatening cardiovascular disease.
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 ANA-001, the
potential benefits of ANA-001 as a treatment for patients with
moderate to severe COVID-19 (patients not requiring ventilators),
and potential milestone payments and royalties that may become due
to the former equity holders of ANA under the acquisition
agreement. 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 ANA-001; the
timing of the availability of data from NeuroBo's clinical trials,
including with respect to ANA-001; the clinical utility,
potential benefits and market acceptance of NeuroBo's product
candidates, including ANA-001; ; 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.