RedHill Biopharma Announces Last Patient Randomized in Part A of Ongoing Phase 2/3 COVID-19 Study of Once-Daily Oral RHB-107 i
PR93049
RedHill Biopharma Announces Last Patient Randomized in Part A of Ongoing Phase 2/3 COVID-19 Study of Once-Daily Oral RHB-107 in Non-Hospitalized Patients
TEL AVIV, Israel and RALEIGH, N.C., Nov. 15, 2021 /PRNewswire=KYODO JBN/ --
- Recruitment completed for Part A of the Phase 2/3 study of once-daily
orally-administered RHB-107 (upamostat) for patients with symptomatic COVID-19
who do not require hospital care
- Top-line results for Part A of the study, designed to evaluate safety and
tolerability of RHB-107 and dose selection, expected in Q1/ 22
- RHB-107 is a novel, investigational antiviral serine protease inhibitor
targeting human cell factors and is expected to be effective against emerging
viral variants
- In parallel, data packages for opaganib, RedHill's other advanced novel oral
COVID-19 drug candidate, have been submitted in the U.S., EU, UK and other
territories, ahead of planned regulatory advice
RedHill Biopharma Ltd. [https://www.redhillbio.com/home/default.aspx] (Nasdaq:
RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company,
today announced that the last patient has been enrolled in Part A of the Phase
2/3 study with novel, once-daily, orally-administered pill RHB-107
(upamostat)[1] for non-hospitalized patients with symptomatic COVID-19. The
study is being conducted in the U.S. and South Africa.
The Phase 2/3 study (NCT04723527
[https://clinicaltrials.gov/ct2/show/NCT04723537?term=RHB-107&draw=2&rank=1])
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
study is a 2-part, multicenter, randomized, double-blind, placebo-controlled,
parallel-group study to evaluate the safety and efficacy of RHB-107. The study
is designed to evaluate time to sustained recovery from illness as the primary
endpoint and for dose selection. A total of 61 patients have been enrolled in
Part A and randomized on a 1:1:1 basis to receive one of two doses of upamostat
or placebo. Based on safety and tolerability results of part A, a dose for part
B will be selected, and patients will be randomized 3:2 to active vs. placebo.
Patients are also tested for specific viral strain. Top-line results from Part
A of the study are expected in the first quarter of 2022, with Part B of the
study expected to follow subsequent to discussions with regulators.
"Once again, we see a rise in COVID-19 infections in many countries across the
world – and the need for effective, simple and safe oral therapies that can be
used outside the hospital setting, and that can work across COVID-19 variants,
is significant," said Terry F. Plasse MD, Medical Director at RedHill.
"Completing randomization for Part A of the RHB-107 Phase 2/3 study is an
important step forward for this elegant, once-daily novel oral pill as a
potential treatment of COVID-19 in the community."
RHB-107 is a novel antiviral drug candidate that targets human serine proteases
involved in preparing the spike protein for viral entry into target cells.
Because it is host-cell targeted, RHB-107 is expected to also be effective
against emerging viral variants with mutations in the spike protein. 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 and Phase 2 studies in different indications, in
approximately 200 patients.
In parallel, data packages for opaganib[2], RedHill's other advanced novel oral
COVID-19 drug candidate – have been submitted to regulators in various
territories including the U.S., EU, UK and others, ahead of planned regulatory
advice. Opaganib's global Phase 2/3 study in patients hospitalized with severe
COVID-19 demonstrated a 62% reduction in mortality as well as improved outcomes
in time to room air and median time to hospital discharge in a sub-group of 251
moderately severe patients, comprising 54% of the study participants.
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 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 Phase 2/3 study for treatment of
patients with symptomatic COVID-19 who do not require inpatient care. In
addition, RHB-107 inhibits several proteases targeting cancer and inflammatory
gastrointestinal disease. 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 ( 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.
Category: R&D
1. RHB-107 (upamostat) is an investigational new drug, not available for
commercial distribution in the United States.
2. Opaganib 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.
Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg
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
Source: RedHill Biopharma Ltd.
本プレスリリースは発表元が入力した原稿をそのまま掲載しております。また、プレスリリースへのお問い合わせは発表元に直接お願いいたします。
このプレスリリースには、報道機関向けの情報があります。
プレス会員登録を行うと、広報担当者の連絡先や、イベント・記者会見の情報など、報道機関だけに公開する情報が閲覧できるようになります。