AsiaNet 86746

TEL AVIV, Israel and RALEIGH, N.C., Nov. 23, 2020, /PRNewswire=KYODO JBN/--

Pre-scheduled independent Data and Safety Monitoring Board (DSMB) unanimously

recommends continuation of the global Phase 2/3 study of orally administered

opaganib in severe COVID-19 pneumonia

Enrollment in the 270-patient global Phase 2/3 COVID-19 study with opaganib is

more than 50% complete

Enrollment completed in the parallel U.S. Phase 2 study evaluating opaganib's

safety and initial efficacy signal in 40 hospitalized patients with severe

COVID-19 pneumonia - data expected in the coming weeks

Emergency use authorization applications planned as early as Q1/2021

Opaganib's mechanism of action potentially minimizes likelihood of resistance

due to viral mutations

RedHill Biopharma Ltd. [https://www.redhillbio.com/RedHill/ ] (Nasdaq: RDHL)

("RedHill" or the "Company"), a specialty biopharmaceutical company, today

announced that the global Phase 2/3 study with opaganib (Yeliva(R),

ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia has

received a unanimous recommendation to continue, following a pre-scheduled

safety review by an independent Data and Safety Monitoring Board (DSMB). The

DSMB's recommendation is based on an unblinded analysis of safety data from the

first 70 patients treated for 14 days.

"With each review of unblinded safety data, by independent reviewers, as part

of our development program, our confidence in the safety profile of opaganib

increases further," said Mark L. Levitt, M.D., Ph.D., Medical Director at

RedHill. "We are fast compiling a robust and extensive safety data set with

opaganib, giving us good reason to look forward to the rapid conclusion of this

study which, if positive, is expected to provide the necessary efficacy data to

support the next step of emergency use applications in the first quarter of

2020."

Enrollment in the 270-patient global Phase 2/3 study with opaganib in patients

with severe COVID-19 pneumonia (NCT04467840)

[https://clinicaltrials.gov/ct2/show/NCT04467840?term=NCT04467840&draw=2&rank=1

]  is more than 50% complete. The study, approved in six countries and rapidly

enrolling across 22 study sites, is on track to deliver top line data in the

first quarter of 2021. This study is focused on and powered for efficacy

evaluation. A prescheduled, unblinded futility interim analysis will be

conducted by the DSMB in the coming weeks, evaluating data from the first 135

subjects that have reached the primary endpoint.

The parallel U.S. Phase 2 study with opaganib (NCT04414618)

[https://clinicaltrials.gov/ct2/show/NCT04414618?term=NCT04414618&draw=2&rank=1

] has completed enrollment of all 40 subjects, with topline data expected in

the coming weeks. This study is not powered for efficacy and is focused on

safety evaluation and identification of efficacy signals.

Opaganib is a novel, orally administered, sphingosine kinase-2 (SK2) selective

inhibitor with demonstrated dual anti-inflammatory and antiviral activity that

acts on the cause and effect of COVID-19 disease, targeting a host cell

component involved in viral replication, potentially minimizing likelihood of

resistance due to viral mutations.

About Opaganib (ABC294640, Yeliva(R))

Opaganib, a new chemical entity, is a proprietary, first-in-class, orally

administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated

dual anti-inflammatory and antiviral activity that targets a host cell

component, potentially minimizing the likelihood for resistance due to viral

mutations. Opaganib has also shown anticancer activity and has the potential to

target multiple oncology, viral, inflammatory and gastrointestinal indications.

Opaganib is also being evaluated in a global Phase 2/3 study and a U.S. Phase 2

study for the treatment of severe COVID-19. Opaganib also received Orphan Drug

designation from the U.S. FDA for the treatment of cholangiocarcinoma and is

being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a

Phase 2 study in prostate cancer.

Preclinical data have demonstrated both anti-inflammatory and antiviral

activities of opaganib, with the potential to reduce inflammatory lung

disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Opaganib

demonstrated potent antiviral activity against SARS-CoV-2, the virus that

causes COVID-19, completely inhibiting viral replication in an in vitro model

of human lung bronchial tissue. Additionally, preclinical in vivo studies[2]

have demonstrated that opaganib decreased fatality rates from influenza virus

infection and ameliorated Pseudomonas aeruginosa-induced lung injury by

reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.

Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and

completed multiple successful preclinical studies in oncology, inflammation,

GI, and radioprotection models, as well as a Phase 1 clinical study in cancer

patients with advanced solid tumors and an additional Phase 1 study in multiple

myeloma.

Under a compassionate use program, patients with severe COVID-19 (as classified

by the WHO ordinal scale) were treated with opaganib in a leading hospital in

Israel. Data from the treatment of these first patients with severe COVID-19

with opaganib have been published[3]. Analysis of treatment outcomes suggested

substantial benefit to patients treated with opaganib under compassionate use

in both clinical outcomes and inflammatory markers as compared to a

retrospective matched case-control group from the same hospital.

All patients in the opaganib-treated group were discharged from hospital on

room air without requiring intubation and mechanical ventilation, whereas 33%

of the matched case-control group required intubation and mechanical

ventilation. Median time to weaning from high-flow nasal cannula was reduced to

10 days in the opaganib-treated group, as compared to 15 days in the matched

case-control group.

The development of opaganib has been supported by grants and contracts from

U.S. federal and state government agencies awarded to Apogee Biotechnology

Corp., including from the NCI, BARDA, the U.S. Department of Defense and the

FDA Office of Orphan Products Development.

The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a

web-based service by the U.S. National Institute of Health, which provides

public access to information on publicly and privately supported clinical

studies.  

About RedHill Biopharma  

RedHill Biopharma Ltd. (Nasdaq: RDHL)[

https://finance.yahoo.com/quote/RDHL?p=RDHL&.tsrc=fin-srch ] is a specialty

biopharmaceutical company primarily focused on gastrointestinal and infectious

diseases. RedHill promotes the gastrointestinal drugs, Movantik(R) for

opioid-induced constipation in adults with non-cancer pain[4], Talicia(R) for

the treatment of Helicobacter pylori (H. pylori) infection in adults[5], and

Aemcolo(R) for the treatment of travelers' diarrhea in adults[6]. RedHill's key

clinical late-stage investigational development programs include: (i) RHB-204,

with a planned Phase 3 study for pulmonary nontuberculous mycobacteria (NTM)

infections; (ii) opaganib (Yeliva(R)), 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-104,

with positive results from a first Phase 3 study for Crohn's disease; (iv)

RHB-102 (Bekinda(R)), with positive results from a Phase 3 study for acute

gastroenteritis and gastritis and positive results from a Phase 2 study for

IBS-D; (v) RHB-107 (upamostat), a Phase 2-stage first-in-class, serine protease

inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is

also being evaluated for COVID-19 and (vi) RHB-106, an encapsulated bowel

preparation. More information about the Company is available at

www.redhillbio.com.

NOTE: This press release, provided for convenience purposes, is a translated

version of the official press release published by the Company in the English

language. For full press release in English language, including the

forward-looking statements disclaimer, please visit:

https://ir.redhillbio.com/press-releases.

Company contact:

Adi Frish

Chief Corporate & Business Development Officer

RedHill Biopharma

+972-54-6543-112

adi@redhillbio.com

Media contact (U.S.):

Bryan Gibbs

Vice President

Finn Partners

+1-212-529-2236

bryan.gibbs@finnpartners.com

[1] Opaganib is an investigational new drug, not available for commercial

distribution.

[2] Xia C. et al. Transient inhibition of sphingosine kinases confers

protection to influenza A virus infected mice. Antiviral Res. 2018 Oct;

158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear

sphingosine-1-phosphate generation and epigenetic regulation of lung

inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

[3] Kurd R, Ben-Chetrit E, Karameh H, Bar-Meir M, Compassionate Use of Opaganib

For Patients with Severe COVID-19. medRxiv 2020.06.20.20099010; doi:

https://doi.org/10.1101/2020.06.20.20099010

[4] Full prescribing information for Movantik(R)(naloxegol) is available at:

www.Movantik.com.  

[5] Full prescribing information for Talicia(R) (omeprazole magnesium,

amoxicillin and rifabutin) is available at: www.Talicia.com.      

[6] Full prescribing information for Aemcolo(R) (rifamycin) is available at:

www.Aemcolo.com.

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SOURCE: RedHill Biopharma Ltd.