Data, from a post hoc analysis of the randomized,
placebo-controlled, double-blind phase 2/3 study of oral opaganib
in COVID-19 pneumonia, showing a 62% reduction in mortality and a
21% improvement in time to room air (no longer needing supplemental
oxygen), has been newly published in the peer-reviewed journal,
Microorganisms
The analysis, from a large sub-group of 251 hospitalized,
moderately severe COVID-19 patients requiring a fraction of
inspired oxygen (FiO2) up to and including 60%, also indicates that
FiO2 of greater than 60% may represent a threshold level for
disease severity, and may potentially be a patient selection
biomarker, an important finding for future therapeutic strategies
and studies
With 30,000 Americans dead due to COVID-19 so far this year
according to the World health Organization[1], new,
effective and safe therapies are still very much needed
With multiple U.S. government collaborations ongoing,
opaganib is a novel, host-directed, potentially broad acting,
orally administered small molecule drug with demonstrated safety
& efficacy profiles in oncology indications, viral infection,
nuclear/radioprotection and other inflammatory diseases
TEL
AVIV, Israel and RALEIGH, N.C., Sept. 3,
2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq:
RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical
company, today announced the publication of data, in the journal
Microorganisms[2], from the 57-site, randomized,
placebo-controlled, double-blind phase 2/3 study of
opaganib[3] in COVID-19 pneumonia (NCT04467840).
The post hoc analysis of data from 251 study participants showed
that hospitalized COVID-19 patients requiring a fraction of
inspired oxygen (FiO2) up to and including 60% (FiO2≤60%) had
better outcomes after 14 days' opaganib treatment (n=117) compared
to placebo (n=134). There was a clinically meaningful 62% reduction
in mortality (5.98% vs. 16.7%; p-value=0.019 (post-hoc)) by day 42.
Additionally, the proportion of patients with FiO2≤60% at baseline
that no longer required supplemental oxygen (≥24 hours) by day 14
of opaganib treatment increased by 21% (76.9% opaganib vs. 63.4%
placebo: p-value =0.033 (post hoc)). The safety profile for
opaganib was similar to placebo.
The data also indicated that FiO2 of greater than 60% may
represent a threshold level for disease severity which could be
utilized as a biomarker, an important finding for future
therapeutic strategies.
"The all-consuming COVID-19 state-of emergency may have
subsided, but the SARS-CoV-2 virus has not – patients are still
contracting COVID-19. 30,000 Americans have died due to COVID-19 so
far this year, and many patients are still hospitalized because of
it. This remains a patient population for whom there are still very
limited treatment options and there remains a substantial need for
effective and safe new therapies," said Dr. Mark Levitt, Chief Scientific Officer at
RedHill. "These published post-hoc study data suggest a
distinct treatment benefit in hospitalized COVID-19 patients
requiring an FiO2 of ≤60%. This, supported by additional data such
as lower inflammatory markers and higher lymphocyte counts, and
added to a favorable safety profile, point to the potential of
opaganib to be an effective new oral therapy for hospitalized
COVID-19 patients, warranting further investigation. Of significant
additional interest is the insight that baseline FiO2 requirement
may be a new clinical biomarker for patient selection and
potentially have a major impact on how hospitalized COVID-19
patients are managed in the future."
About Opaganib (ABC294640)
Opaganib, a proprietary investigational host-directed and
potentially broad-acting drug, is a first-in-class, orally
administered sphingosine kinase-2 (SPHK2) selective inhibitor with
anticancer, anti-inflammatory and antiviral activity, targeting
multiple potential indications, including several cancers, diabetes
and obesity-related disorders, gastrointestinal acute radiation
syndrome (GI-ARS), Sulfur Mustard exposure, COVID-19, Ebola and
other viruses as part of pandemic preparedness.
Opaganib's host-directed action is thought to work through the
inhibition of multiple pathways, the induction of autophagy and
apoptosis, and disruption of viral replication, through
simultaneous inhibition of three sphingolipid-metabolizing enzymes
in human cells (SPHK2, DES1 and GCS).
Opaganib has been selected for evaluation by two U.S. government
countermeasures programs for Acute Radiation Syndrome (ARS) and
Sulfur Mustard exposure, both funded by the NIH: The Radiation and
Nuclear Countermeasures Program (RNCP), led by the National
Institute of Allergy and Infectious Diseases (NIAID), part of the
HHS National Institutes of Health, for the nuclear medical
countermeasures (MCM) product development pipeline selected
opaganib for development as a potential treatment for Acute
Radiation Syndrome (ARS); and the Chemical Medical Countermeasures
(Chem MCM) Program and the Chemical Countermeasures Research
Program (CCRP), managed respectively by the Administration for
Strategic Preparedness and Response (ASPR) / Biomedical Advanced
Research and Development Authority (BARDA) and NIH/NIAID selected
opaganib for evaluation as a potential medical countermeasure (MCM)
against Sulfur Mustard exposure.
Opaganib has demonstrated antiviral activity against SARS-CoV-2,
multiple variants, and several other viruses, such as Influenza A
and Ebola. Opaganib delivered a statistically significant increase
in survival time when given at 150 mg/kg twice a day (BID) in a
United States Army Medical Research Institute of Infectious
Diseases (USAMRIID) in vivo Ebola virus study, making it the
first host-directed molecule to show activity in Ebola virus
disease. Opaganib also recently demonstrated a distinct synergistic
effect when combined individually with remdesivir (Veklury®, Gilead
Sciences Inc.), significantly improving potency while maintaining
cell viability, in a U.S. Army-funded and conducted in vitro
Ebola virus study.
Being host-targeted, and based on data accumulated to date,
opaganib is expected to maintain effect against emerging viral
variants. In prespecified analyses of Phase 2/3 clinical data in
hospitalized patients with moderate to severe COVID-19, oral
opaganib demonstrated improved viral RNA clearance, faster time to
recovery and significant mortality reduction in key patient
subpopulations versus placebo on top of standard of care. Opaganib
has demonstrated its safety and tolerability profile in more than
470 people in multiple clinical studies and expanded access use.
Data from the opaganib global Phase 2/3 study was published
in Microorganisms.
Opaganib has received several orphan-drug designations from the
FDA in oncology and other diseases and has undergone studies in
advanced cholangiocarcinoma (Phase 2a) and prostate cancer.
Opaganib also has a Phase 1 chemoradiotherapy study protocol ready
for FDA-IND submission.
Opaganib has also shown positive preclinical results in renal
fibrosis, and has the potential to target multiple oncology,
radioprotection, viral, inflammatory, and gastrointestinal
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
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) opaganib
(ABC294640), a first-in-class oral broad-acting,
host-directed SPHK2 selective inhibitor with potential for pandemic
preparedness, targeting multiple indications with a U.S. government
collaboration for development for Acute Radiation Syndrome (ARS), a
Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program
in oncology; (ii) RHB-107 (upamostat), an
oral broad-acting, host-directed, serine protease inhibitor with
potential for pandemic preparedness is in late-stage development as
a treatment for non-hospitalized symptomatic COVID-19, with
non-dilutive external funding covering the entirety of the RHB-107
arm of the 300-patient Phase 2 adaptive platform trial, and is also
targeting multiple other cancer and inflammatory gastrointestinal
diseases; (iii) RHB-102, with potential UK submission
for chemotherapy and radiotherapy induced nausea and vomiting,
positive results from a Phase 3 study for acute gastroenteritis and
gastritis and positive results from a Phase 2 study for IBS-D;
(iv) RHB-104, with positive results from a first Phase
3 study for Crohn's disease; and (v) RHB-204, a
Phase 3-stage program for pulmonary nontuberculous mycobacteria
(NTM) disease.
More information about the Company is available at
www.redhillbio.com / X.com/RedHillBio.
Forward Looking Statements
This press release contains "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995 and may discuss investment opportunities, stock analysis,
financial performance, investor relations, and market trends. Such
statements may be preceded by the words "intends," "may," "will,"
"plans," "expects," "anticipates," "projects," "predicts,"
"estimates," "aims," "believes," "hopes," "potential" or similar
words and include, among others, statements regarding the potential
effects of opaganib in the treatment of COVID-19. 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: market
and other conditions; the Company's ability to regain compliance
with the Nasdaq Capital Market's minimum bid price requirements;
the risk that the addition of new revenue generating products or
out-licensing transactions will not occur; the risk that acceptance
onto the RNCP Product Development Pipeline will not guarantee
ongoing development or that any such development will not be
completed or successful; the risk that the FDA does not agree with
the Company's proposed development plans for opaganib for any
indication; the risk that observations from preclinical studies are
not indicative or predictive of results in clinical trials; the
risk that the FDA pre-study requirements will not be met and/or
that the Phase 3 study of RHB-107 in COVID-19 outpatients will not
be approved to commence or if approved, will not be completed or,
should that be the case, that we will not be successful in
obtaining alternative non-dilutive development funding for RHB-107;
the risk that RHB-107's late-stage development for non-hospitalized
COVID-19 will not benefit from the resources redirected from the
terminated RHB-204 Phase 3 study, and that the Phase 2/3 COVID-19
study for RHB-107 may not be successful and, even if successful,
such studies and results may not be sufficient for regulatory
applications, including emergency use or marketing applications,
and that additional COVID-19 studies for opaganib and RHB-107 are
likely to be required; the risk that the Company will not
successfully commercialize its products; as well as risks and
uncertainties associated with (i) the initiation, timing, progress
and results of the Company's research, manufacturing, pre-clinical
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
pre-clinical studies or clinical trials or the development of a
commercial companion diagnostic for the detection of MAP; (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
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 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, pre-clinical 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 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 experiences using investigative drugs under the Company's
Expanded Access Program; (xiv) competition from other companies and
technologies within the Company's industry; and (xv) the hiring and
employment commencement date of executive managers. 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 April 8, 2024. 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. WHO COOVID-19
Dashboard: https://data.who.int/dashboards/covid19/deaths?n=o.
2. Neuenschwander FC, Barnett-Griness O, Piconi S, Maor
Y, Sprinz E, Assy N, Khmelnitskiy O, Lomakin NV, Goloshchekin BM,
Nahorecka E, et al. Effect of Opaganib on Supplemental Oxygen and
Mortality in Patients with Severe SARS-CoV-2 Based upon FIO2
Requirements. Microorganisms. 2024; 12(9):1767.
https://doi.org/10.3390/microorganisms12091767.
3. Opaganib is an investigational new drug, not
available for commercial distribution.
4. Talicia® (omeprazole magnesium, amoxicillin and
rifabutin) is indicated for the treatment of H. pylori infection in
adults. For full prescribing information see: www.Talicia.com.
5. Aemcolo® (rifamycin) is indicated for the
treatment of travelers' diarrhea caused by noninvasive strains of
Escherichia coli in adults. For full prescribing information see:
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
Category: R&D
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SOURCE RedHill Biopharma Ltd.