FDA clears IND application for Phase 2/3 study with RedHill's
second novel COVID-19 candidate, RHB-107 (upamostat), an orally
administered novel serine protease inhibitor, with demonstrated
antiviral and potential tissue-protective effects
The Phase 2/3 study is designed to evaluate outpatient-based
treatment of patients with symptomatic COVID-19 disease – the vast
majority of treated patients
RHB-107 has demonstrated strong inhibition of SARS-CoV-2
viral replication in a human bronchial cell model and targets a
host cell component involved in viral replication, minimizing
potential for resistance due to viral mutations
In parallel, RedHill is rapidly advancing its development
program with opaganib in severe COVID-19 pneumonia; The U.S. Phase
2 study is fully enrolled with topline data expected within weeks,
and a global Phase 2/3 study which is more than 50% enrolled, with
topline data expected in Q1/2021 in support of potential emergency
use applications
TEL AVIV, Israel and
RALEIGH, N.C., Nov. 17, 2020 /PRNewswire/ -- RedHill
Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a
specialty biopharmaceutical company, today announced that the U.S.
Food and Drug Administration (FDA) has cleared the Company's
Investigational New Drug (IND) application for a Phase 2/3 study
evaluating orally administered RHB-107 (upamostat)[1] in patients
with symptomatic COVID-19 who do not require hospitalization.
"This is a significant milestone in our efforts to combat the
effects of the COVID-19 pandemic. The ability to treat patients
earlier in the course of COVID-19 disease, using an oral therapy
that enables treatment outside of a hospital setting, is of
critical importance given the large proportion of patients that are
not hospitalized but are still very much at risk of disease
progression," said Terry F.
Plasse MD, Medical Director at RedHill. "With RHB-107
and opaganib[2], RedHill has two novel, late-stage, oral
therapeutic candidates with potential to reduce the impact of
COVID-19 disease, both of which target host cell components,
potentially minimizing the likelihood of resistance due to
emergence of viral mutations."
RHB-107 is a proprietary, first-in-class, orally administered
potent inhibitor of several serine proteases, with demonstrated
antiviral and potential tissue-protective effects. This combined
antiviral and potential tissue-protective action make it a
promising candidate for evaluation as a treatment for COVID-19
disease. RHB-107 has demonstrated strong inhibition of SARS-CoV-2
viral replication in an in vitro human bronchial cell model
and its safety profile has been demonstrated in approximately 200
people, including in Phase 2 studies in oncology indications.
RedHill licensed RHB-107 (formerly Mesupron) from Heidelberg Pharma
AG (FWB: HPHA, formerly Wilex AG).
The randomized, parallel-group double-blind Phase 2/3 study is
expected to start enrolling patients early next year. The study
will enroll patients with symptomatic diagnostically confirmed
COVID-19 who do not require inpatient care. RHB-107 will be
administered once daily for 14 days, with patients receiving
follow-up for eight weeks from first dosing. The primary endpoints
will be time to recovery from symptomatic illness compared to
placebo, as well as safety and tolerability of RHB-107. Several
secondary and exploratory endpoints will also be assessed.
The late-stage development program for RedHill's other COVID-19
candidate, opaganib, in patients with severe COVID-19 pneumonia
includes: The U.S. Phase 2 study (NCT04414618) is now fully
enrolled and expected to report topline data in the coming weeks;
and the global Phase 2/3 study (NCT04467840) which is more than 50%
enrolled and is on track to enroll up to 270 patients and report
topline data in support of potential emergency use applications in
the first quarter of 2021. Both studies are randomized,
double-blind, parallel-arm, placebo-controlled trials with opaganib
in patients with severe COVID-19 pneumonia requiring
hospitalization and treatment with supplemental oxygen.
About RHB-107 (upamostat)
RHB-107 is a proprietary, first-in-class, orally administered
potent inhibitor of several serine proteases, with demonstrated
antiviral and potential tissue-protective effects. This combined
antiviral and potential tissue-protective action make it a strong
candidate for evaluation as a treatment for COVID-19 disease. In
addition, RHB-107 has potential in targeting cancer, inflammatory
lung diseases and gastrointestinal diseases, and has undergone
several Phase 1 studies and two Phase 2 studies, demonstrating its
clinical safety profile in approximately 200 patients. RedHill
acquired the exclusive worldwide rights to RHB-107, excluding
China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharmaceuticals (formerly
WILEX AG) for all indications.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty
biopharmaceutical company primarily focused on gastrointestinal and
infectious diseases. RedHill promotes the gastrointestinal drugs,
Movantik® for opioid-induced constipation in
adults with non-cancer pain[3],
Talicia® for the treatment of Helicobacter pylori
(H. pylori) infection in adults[4], and
Aemcolo® for the treatment of travelers' diarrhea
in adults[5]. RedHill's key clinical
late-stage investigational development programs include: (i)
RHB-204, with a planned Phase 3 study for pulmonary
nontuberculous mycobacteria (NTM) disease; (ii) opaganib
(Yeliva®), a first-in-class SK2
selective inhibitor targeting multiple indications with a Phase 2/3
program for COVID-19 and Phase 2 studies for prostate cancer and
cholangiocarcinoma ongoing; (iii) RHB-104, with positive
results from a first Phase 3 study for Crohn's disease; (iv)
RHB-102 (Bekinda®), with positive results
from a Phase 3 study for acute gastroenteritis and gastritis and
positive results from a Phase 2 study for IBS-D; (v) RHB-107
(upamostat), a Phase 2-stage first-in-class, serine
protease inhibitor, targeting cancer and inflammatory
gastrointestinal diseases and is also being evaluated for COVID-19
and (vi) RHB-106, an encapsulated bowel preparation.
More information about the Company is available at
www.redhillbio.com.
This press release contains "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995. Such statements may be preceded by the words
"intends," "may," "will," "plans," "expects," "anticipates,"
"projects," "predicts," "estimates," "aims," "believes," "hopes,"
"potential" or similar words. Forward-looking statements are based
on certain assumptions and are subject to various known and unknown
risks and uncertainties, many of which are beyond the Company's
control and cannot be predicted or quantified, and consequently,
actual results may differ materially from those expressed or
implied by such forward-looking statements. Such risks and
uncertainties include, without limitation, the risk that enrollment
in the company's Phase 2/3 study evaluating RHB-107 in patients
with symptomatic COVID-19 will be delayed, the risk that the
Company's Phase 2/3 development program evaluating opaganib will
not be successful and that the data from this clinical study will
be delayed, if at all; the risk of a delay in receiving data to
support emergency use applications or in making such emergency use
applications, if at all; the risk that the U.S. Phase 2 clinical
study evaluating opaganib will not be successful and the risk that
the data from this clinical study will be delayed if at all; the
risk that the Company will not initiate the Phase 2/3 study for
opaganib in certain geographies, will not expand this study to
additional countries and that it will not be successful and that
enrollment will be delayed; the risk that other COVID-19 patients
treated with opaganib will not show any clinical improvement; the
development risks of early-stage discovery efforts for a disease
that is still little understood, including difficulty in assessing
the efficacy of opaganib for the treatment of COVID-19, if at all;
intense competition from other companies developing potential
treatments and vaccines for COVID-19; the effect of a potential
occurrence of patients suffering serious adverse events using
opaganib under compassionate use programs, as well as risks and
uncertainties associated with (i) the initiation, timing, progress
and results of the Company's research, manufacturing, preclinical
studies, clinical trials, and other therapeutic candidate
development efforts, and the timing of the commercial launch of its
commercial products and ones it may acquire or develop in the
future; (ii) the Company's ability to advance its therapeutic
candidates into clinical trials or to successfully complete its
preclinical studies or clinical trials (iii) the extent and number
and type of additional studies that the Company may be required to
conduct and the Company's receipt of regulatory approvals for its
therapeutic candidates, and the timing of other regulatory filings,
approvals and feedback; (iv) the manufacturing, clinical
development, commercialization, and market acceptance of the
Company's therapeutic candidates and Talicia®; (v) the
Company's ability to successfully commercialize and promote
Movantik®, Talicia® and Aemcolo®;
(vi) the Company's ability to establish and maintain corporate
collaborations; (vii) the Company's ability to acquire products
approved for marketing in the U.S. that achieve commercial success
and build and sustain its own marketing and commercialization
capabilities; (viii) the interpretation of the properties and
characteristics of the Company's therapeutic candidates and the
results obtained with its therapeutic candidates in research,
preclinical studies or clinical trials; (ix) the implementation of
the Company's business model, strategic plans for its business and
therapeutic candidates; (x) the scope of protection the Company is
able to establish and maintain for intellectual property rights
covering its therapeutic candidates and commercial products and its
ability to operate its business without infringing the intellectual
property rights of others; (xi) parties from whom the Company
licenses its intellectual property defaulting in their obligations
to the Company; (xii) estimates of the Company's expenses, future
revenues, capital requirements and needs for additional financing;
(xiii) the effect of patients suffering adverse events using
investigative drugs under the Company's Expanded Access Program;
and (xiv) competition from other companies and technologies within
the Company's industry. More detailed information about the Company
and the risk factors that may affect the realization of
forward-looking statements is set forth in the Company's filings
with the Securities and Exchange Commission (SEC), including the
Company's Annual Report on Form 20-F filed with the SEC on
March 4, 2020. All forward-looking
statements included in this press release are made only as of the
date of this press release. The Company assumes no obligation to
update any written or oral forward-looking statement, whether as a
result of new information, future events or otherwise unless
required by law.
Company
contact:
Adi Frish
Chief Corporate &
Business Development Officer
RedHill
Biopharma
+972-54-6543-112
adi@redhillbio.com
|
Media contact
(U.S.):
Bryan
Gibbs
Vice
President
Finn
Partners
+1 212 529
2236
bryan.gibbs@finnpartners.com
|
[1] RHB-107 (upamostat) is an investigational new drug, not
available for commercial distribution.
[2] Opaganib is an investigational new drug, not available for
commercial distribution
[3] Full prescribing information for Movantik®
(naloxegol) is available at: www.Movantik.com.
[4] Full prescribing information for Talicia®
(omeprazole magnesium, amoxicillin and rifabutin) is available at:
www.Talicia.com.
[5] Full prescribing information for Aemcolo®
(rifamycin) is available at: www.Aemcolo.com.
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