PR88927

TEL AVIV, Israel and RALEIGH, N.C., April 9, 2021 /PRNewswire=KYODO JBN/ --

- Independent Data Safety Monitoring Board unanimously recommends continuation

of the global Phase 2/3 study of orally-administered opaganib in severe

COVID-19 pneumonia based on review of unblinded safety data from the first 255

treated patients

- The 464-patient global Phase 2/3 COVID-19 study is over 75% enrolled, with

completion of enrollment expected in the coming weeks

- Opaganib potentially minimizes likelihood of resistance due to viral

mutations by targeting a human cell component involved in viral replication

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 orally-administered opaganib

(Yeliva®, ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia

has received a unanimous recommendation to continue, following a fourth

independent Data Safety Monitoring Board (DSMB) safety review. The DSMB's

recommendation is based on an analysis of unblinded safety data from the first

255 patients treated for 14 days, extending the total opaganib safety database

to approximately 380 patients.

Mark L. Levitt, M.D., Ph.D., Medical Director at RedHill, said: "With

approximately 380 patients in the opaganib safety database following this

positive fourth DSMB review, we are building a clear picture of the safety

profile of opaganib." Dr. Levitt continued: "Moreover, adding together the

positive Phase 2 data, the successful DSMB futility reviews and the outcomes

from compassionate use of opaganib, we look forward with optimism to the

reporting of top-line data from the Phase 2/3 study, which will provide the

clearest indication to date of opaganib's promise in treating COVID-19."

The global Phase 2/3 randomized, double-blind, parallel-arm, placebo-controlled

study of opaganib in patients with severe COVID-19 pneumonia requiring

hospitalization and treatment with supplemental oxygen (NCT04467840) [

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

], is over 75% enrolled in approximately 40 recruiting sites.

RedHill recently announced positive top-line safety and efficacy data [

https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=2432&PID=0&IID=19319

]from the non-powered U.S. Phase 2 study with opaganib in 40 patients with

COVID-19 pneumonia, in which opaganib demonstrated greater improvement in

reducing oxygen requirement by end of treatment on Day 14, on top of

standard-of-care. The Phase 2 data also showed no material safety differences

between the opaganib and placebo on top of standard-of-care treatment arms -

further adding to the growing safety database for opaganib.

To find out more about RedHill Biopharma's Expanded Access policy, please

visit: www.redhillbio.com/expandedaccess.

About Opaganib (Yeliva(R), ABC294640)

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 of viral replication, potentially minimizing the likelihood of

viral resistance. Opaganib has also shown anticancer activity and has the

potential to target multiple oncology, viral, inflammatory, and

gastrointestinal indications.

Opaganib 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. Opaganib is also

being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3

study and has demonstrated positive safety and efficacy signals in preliminary

top-line data from a 40-patient U.S. Phase 2 study.

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

have demonstrated opaganib's potential to ameliorate inflammatory lung

disorders, such as pneumonia, and mitigate pulmonary fibrotic damage, and has

shown 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[2].

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.

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) 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[3], Talicia(R) for the treatment of Helicobacter pylori (H. pylori)

infection in adults[4], and Aemcolo(R) 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 (Yeliva(R), ABC294640), a

first-in-class SK2 selective inhibitor targeting multiple indications with

positive Phase 2 COVID-19 data and an ongoing Phase 2/3 program for COVID-19

and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii)

RHB-107 (upamostat), a 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 (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; 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 the risk of a delay in top-line data from the Phase

2/3 COVID-19 study, that such a study may not be successful, that opaganib will

not be effective against emerging viral variants 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(R); (v) the Company's ability to successfully

commercialize and promote Movantik(R), Talicia(R) and Aemcolo(R); (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.: 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

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

www.Movantik.com.  

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

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

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

www.Aemcolo.com.

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Source: RedHill Biopharma Ltd.