TEL AVIV, Israel and
RALEIGH, N.C., Feb. 17, 2021 /PRNewswire/ -- RedHill
Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a
specialty biopharmaceutical company, today announced that the first
patient was dosed in its U.S. Phase 2/3 study of
orally-administered RHB-107 (upamostat)[1], an
investigational new drug for patients with symptomatic COVID-19 who
do not require hospital care.
Dror Ben-Asher, RedHill's CEO
said: "RedHill is rapidly advancing two Phase 3-stage,
orally-administered, novel molecules for the treatment of COVID-19:
RHB-107 for outpatient use and opaganib for hospitalized patients.
With these two promising and complementary shots on goal across the
disease severity spectrum, RedHill is positioned at the very
forefront of COVID-19 therapeutic research, aiming to address both
existing and emerging mutations."
The U.S. Phase 2/3 study (NCT04723527) is aimed at evaluating
treatment with RHB-107 in patients with symptomatic COVID-19 early
in the course of the disease, with a simple once-daily oral
treatment in an outpatient setting.
RHB-107 is a novel, potent inhibitor of serine proteases, that
targets human cell factors involved in preparing the spike protein
for viral entry into target cells and is therefore expected to be
effective against emerging viral variants with mutations in the
spike protein. RHB-107 demonstrated strong inhibition of SARS-CoV-2
viral replication in an in vitro human bronchial epithelial
cell model and previous preclinical work demonstrated potential
tissue-protective action. Previous clinical studies of RHB-107
included several Phase 1 and Phase 2 studies in different
indications, demonstrating its clinical safety profile in
approximately 200 patients.
"Dosing of the first patient in the Phase 2/3 study of RHB-107
in patients with symptoms but not needing hospital care, the
largest COVID-19 patient group, is a key step forward in RedHill's
efforts to help combat the widespread effects of this pandemic.
Together with opaganib, we now have two novel, orally-administered
compounds, with unique mechanisms of action, in advanced
development for treating patients at different stages of COVID-19
disease," said Terry F. Plasse
MD, Medical Director at RedHill. "The ability to treat patients
early in the course of COVID-19 disease, with an oral therapy
designed to be used outside the hospital, and with a compound
expected to be effective against emerging viral variants, has the
potential to be a game-changer in managing this disease. The
ground-breaking design of the study allows us to collect data at a
level previously possible only in hospital while enabling patients
to stay in the comfort of their homes and decreasing exposure risk
of this highly contagious disease."
This study is a 2-part, multicenter, randomized, double-blind,
placebo-controlled, parallel-group study to evaluate the safety and
efficacy of RHB-107. The first part of the study is designed for
dose selection and is planned to enroll 60 patients. The second
part of the study is planned to enroll 250 patients and will
evaluate time to sustained recovery from illness as the primary
endpoint. Each patient will be tested for specific viral
strain.
The study is unique in a COVID-19 trial setting in its extensive
use of telemetry and electronic patient-reported outcome (ePRO)
data collection and is based on the latest FDA guidance for symptom
monitoring. Following the patients' initial visit to a medical
facility, a research-trained nurse will make periodic home visits
to study patients to collect samples for safety and virology
monitoring. This innovative use of home-based safety and efficacy
monitoring technologies, together with home nursing support,
enables patients to participate in the study from home with the
benefit of hospital-level monitoring, enhancing patient comfort and
markedly decreasing the risk of SARS-CoV-2 exposure to medical
staff and other members of the public.
In parallel, the late-stage development program for RedHill's
second COVID-19 drug candidate, opaganib[2] in patients
hospitalized with severe COVID-19, is progressing rapidly. Recently
announced top-line results from the U.S. Phase 2 study of opaganib
demonstrated safety and positive efficacy data across key primary
and secondary endpoints. The global Phase 2/3 study continues to
enroll, having recently received a positive DSMB futility review,
with top-line data and potential subsequent global emergency use
authorization applications expected in the second quarter of
2021.
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. RHB-107 targets
human cell factors involved in preparing the spike protein for
viral entry into target cells and is therefore expected to be
effective against emerging viral variants with mutations in the
spike protein. RHB-107 is being evaluated in a U.S. Phase 2/3 study
for treatment of patients with symptomatic COVID-19 who do not
require inpatient care. In addition, RHB-107 has potential in
targeting cancer, inflammatory lung diseases and gastrointestinal
diseases. RHB-107 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 (FSE:
HPHA) (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[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
development programs include: (i) RHB-204, with an
ongoing Phase 3 study for pulmonary nontuberculous mycobacteria
(NTM) disease; (ii) opaganib (Yeliva®,
ABC294640), 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-107
(upamostat), a serine protease inhibitor in a U.S. Phase 2/3
study as treatment for symptomatic COVID-19, and targeting multiple
other cancer and inflammatory gastrointestinal diseases; (iv)
RHB-104, with positive results from a first Phase 3 study
for Crohn's disease; (v) 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; and (vi) RHB-106, an
encapsulated bowel preparation. More information about the Company
is available at www.redhillbio.com /
https://twitter.com/RedHillBio.
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, not completed or not successful; the risk that
RHB-107 will not be effective against emerging viral variants
with mutations in the spike protein; 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 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 RHB-107 or 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
RHB-107 and 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.
1. RHB-107 (upamostat) is an investigational new
drug, not available for commercial distribution in the United States.
2. Opaganib (Yeliva®, ABC294640) is an investigational
new drug, not available for commercial distribution in the United States.
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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Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Media contacts:
U.S.: Bryan Gibbs, Finn
Partners
+1 212 529 2236
bryan.gibbs@finnpartners.com
UK: Amber Fennell, Consilium
+44 (0) 7739 658 783
fennell@consilium-comms.com
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SOURCE RedHill Biopharma Ltd.