AsiaNet 89952

TEL AVIV, Israel and RALEIGH, NC, June 7, 2021, /PRNewswire=KYODO JBN/--

- The global Phase 2/3 study of orally-administered opaganib for the treatment

of severe COVID-19 enrolled a total of 475 patients, more than the planned 464

- Opaganib is uniquely positioned as a leading novel, dual-action,

investigational COVID-19 oral pill

- Blinded blended mortality rates encouraging compared to mortality rates from

large platform studies such as RECOVERY

- Four independent DSMB recommendations to continue the study based on

unblinded safety and futility reviews

- Opaganib is host-targeted and is therefore expected to be effective against

emerging viral variants

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

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

announced that it has completed enrollment and randomized the last patient in

the global Phase 2/3 study with opaganib (Yeliva(R), ABC294640)[1] in patients

hospitalized with severe COVID-19 pneumonia (NCT04467840) [

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

]. A total of 475 patients were randomized, more than the planned 464.

The primary endpoint of the study is the proportion of patients breathing room

air without oxygen support by Day 14. The study captures additional important

outcome measures in the follow up period of up to 6 weeks, such as the time to

hospital discharge, improvement according to the World Health Organization

Ordinal Scale for Clinical Improvement and incidence of intubation and

mortality.

An evaluation of the blinded blended intubation and mortality rates to date is

encouraging as compared to reported rates of mortality from large platform

studies such as RECOVERY, and other studies in similar patient populations[2].

Furthermore, four independent DSMB recommendations to continue the study were

already provided following unblinded safety and futility reviews.

"Enrollment completion of this 475-patient global study of oral opaganib for

COVID-19 is a truly exciting milestone in the urgent search for an effective

pill to treat COVID-19, positioning opaganib as a leading novel, dual-action,

investigational COVID-19 oral treatment," said Mark L. Levitt, MD, Ph.D.,

Medical Director at RedHill. "Acting on the cause and effect of COVID-19

through a dual antiviral and anti-inflammatory effect, opaganib is

host-targeted and is therefore expected to be effective against emerging viral

variants. With waves of COVID-19 continuing to wash over many countries,

coupled with the specter of new variants, it is more critical than ever that

the world has access to an oral pill to treat COVID-19."

In addition to ongoing discussions with the FDA and other regulators, the

Company has also met with the EMA to talk about a European pathway. As with all

discussions with regulatory bodies, next steps will be guided by study results.

Discussions are also ongoing with potential partners who are interested in the

rights to opaganib in various countries.  

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 dual

anti-inflammatory and antiviral activity, that is host-targeted and is

therefore expected to be effective against emerging viral variants. Opaganib

has also shown anticancer activity and has the potential to target multiple

oncology, viral, inflammatory, and gastrointestinal indications.

Opaganib is 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 has 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.

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 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[3].

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[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 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 delay in last patient visit and top-line data

from the Phase 2/3 COVID-19 study for opaganib, that the Phase 2/3 COVID-19

study for opaganib may not be successful and, even if successful, such study

and results may not be sufficient for regulatory applications, including

emergency use or marketing applications, and that additional COVID-19 studies

for opaganib are likely to be required by regulatory authorities to support

such potential applications and the use or marketing of opaganib for COVID-19

patients, 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] Based on preliminary blinded blended data from 463 patients. The Company

did not conduct a head-to-head comparison study in the same patient population.

The theoretical comparison between the global Phase 2/3 study with opaganib and

reported rates of mortality from large platform studies such as RECOVERY, and

other studies in similar patient populations, serves as a general benchmark and

should not be construed as a direct and/or applicable comparison as if the

Company conducted a head-to-hear comparison study.

[3] 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.

[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.