RedHill
Announces Positive Phase 2 Study Results with Oral RHB-107 in
Non-Hospitalized COVID-19
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Phase
2 part of Phase 2/3 study of once-daily oral RHB-107 in symptomatic
COVID-19 successfully met the study's primary endpoint showing good
safety and tolerability and highly promising efficacy
results
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100%
reduction in hospitalization due to COVID-19 with zero patients
(0/41) on the RHB-107 arms versus 15% (3/20) hospitalized on the
placebo-controlled arm
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--
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87.8%
reduction in reported
new severe COVID-19 symptoms after treatment
initiation,
with only one patient in the RHB-107 treated group
2.4%,
(1/41) versus
20% (4/20) of patients in the placebo-controlled
arm)
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The most common
variant among patients in the study was Delta; RHB-107, a novel,
investigational oral antiviral serine protease inhibitor, targeting
host rather than viral factors, is expected to maintain effect
against emerging viral variants
TEL AVIV, Israel and RALEIGH,
NC, March 1, 2022, 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
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Media
contacts:
U.S. / UK: Amber
Fennell, Consilium
+44 (0) 7739 658 783
fennell@consilium-comms.com
|
Category: R&D