TEL AVIV, Israel and
RALEIGH, N.C., March 1, 2022 /PRNewswire/ -- RedHill
Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"),
a specialty biopharmaceutical company, today announced positive
top-line results from the Phase 2 part of the Phase 2/3 study of
once-daily oral RHB-107 (upamostat)[1] in
non-hospitalized symptomatic COVID-19 patients, predominantly
conducted in the U.S. (60/61 patients) as well as South Africa.
Although not powered for efficacy assessment, the study showed
highly promising efficacy results delivering a 100% reduction in
hospitalization due to COVID-19, with zero patients on RHB-107
hospitalized with COVID-19 (0/41) compared to 15% on the
placebo-controlled arm requiring hospitalization (3/20) (nominal
p-value=0.0317). Furthermore, the study showed an 87.8% reduction
in reported new severe COVID-19 symptoms, with only one patient on
RHB-107 (2.4%, 1/41) compared to 20% (4/20) of patients on the
placebo-controlled arm experiencing new COVID-19 related severe
symptoms (nominal p-value=0.036).
The study met its primary outcome measure, demonstrating a
favorable safety and tolerability profile of RHB-107. Study arms
were well balanced with respect to baseline disease severity, risk
factors and vaccination status. Patients were also tested for the
specific viral strain (last patient randomized November 12, 2021), with the most common variant
being Delta, found in 62.5% of the patients that had next
generation sequencing (NGS).
"These very promising efficacy results, achieved despite a small
overall sample size, are impressive. Coupling the efficacy results
with successfully meeting the primary endpoint of good safety and
tolerability and convenient once-daily dosing, positions oral
RHB-107 as a potential highly beneficial treatment for COVID-19
outpatients early in the course of disease in order to reduce
symptom severity and prevent disease progression and
hospitalization. Given the limitations of current options for early
treatment of COVID-19, we are excited to progress the development
of RHB-107, subject to additional discussions with regulatory
authorities," said Terry F.
Plasse MD, Medical Director at RedHill. "Equally
important is our expectation that RHB-107, with its human cell
factor targeting, would maintain its action irrespective of spike
protein mutations, thus likely making it a highly desirable
variant-agnostic potential treatment option."
The Phase 2/3 multicenter, randomized, double-blind,
placebo-controlled, parallel-group study (NCT04723527)
with RHB-107 is aimed at evaluating treatment in patients with
symptomatic COVID-19 early in the course of the disease, with a
once-daily oral treatment that can be prescribed and used in the
non-hospitalized patient population. The Phase 2 part of the study
was designed to evaluate safety for dose selection and to provide
preliminary assessment of parameters to be used for efficacy
evaluation in Part B. A total of 61 patients were enrolled in Part
A and randomized on a 1:1:1 basis to receive one of two dose levels
of RHB-107 or a placebo control.
Next steps for the study will follow data submission and
discussion with regulators.
About RHB-107 (upamostat)
RHB-107 is a proprietary, first-in-class, orally-administered
antiviral, that targets human serine proteases involved in
preparing the spike protein for viral entry into target cells.
RHB-107 targets host 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 Phase 2/3 study
for treatment of patients with symptomatic COVID-19 who do not
require inpatient care. RHB-107 has demonstrated strong inhibition
of SARS-CoV-2 viral replication in an in vitro human
bronchial epithelial cell model. RHB-107 has a strong clinical
safety and biodistribution profile, demonstrated in previous
clinical studies, including several Phase 1 studies and two Phase 2
studies, demonstrating its clinical safety profile in approximately
200 patients. In addition, RHB-107 inhibits several proteases
targeting cancer and inflammatory gastrointestinal disease. RedHill
acquired the exclusive worldwide rights to RHB-107, excluding
China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharma (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[2], Talicia® for the
treatment of Helicobacter pylori (H. pylori) infection in
adults[3], and Aemcolo® for the
treatment of travelers' diarrhea in adults[4].
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 (
ABC294640), a first-in-class, oral 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), an oral 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, 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 the follow up for Part A and the
commencement of Part B of the 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 and/or opaganib
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 RHB-107 and/or 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 RHB-107 in certain geographies,
including South Africa, will not
expand this study to additional sites in the U.S and that it will
not be successful and that enrollment will be delayed; the risk
that 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 relatively new disease, 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 RHB-107, 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 18, 2021. 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
contacts:
U.S. / UK:
Amber Fennell, Consilium
+44 (0) 7739 658 783
fennell@consilium-comms.com
|
Category: R&D
[1] RHB-107 (upamostat) is an investigational new
drug, not available for commercial distribution in the United States.
[2] Full prescribing information for
Movantik® (naloxegol) is available at:
www.Movantik.com.
[3] Full prescribing information for
Talicia® (omeprazole magnesium, amoxicillin and
rifabutin) is available at:
www.Talicia.com.
[4] Full prescribing information for
Aemcolo® (rifamycin) is available at:
www.Aemcolo.com.
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SOURCE RedHill Biopharma Ltd.