PR90724

TEL AVIV, Israel and RALEIGH, NC, July 19, 2021, /PRNewswire=KYODO JBN/--

Patient follow-up completed for the 475-patient global Phase 2/3 study of oral

opaganib for severe COVID-19

Top-line results expected in the coming weeks

Opaganib, a novel, dual antiviral and anti-inflammatory investigational

COVID-19 pill, demonstrated potent inhibition of Beta and Gamma variants and is

expected to be effective against emerging variants, including Delta and Delta

Plus

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty

pharma company that is a leader in the development of novel oral therapies for

COVID-19, today announced that all treatment and follow-up has now been

completed in the 475-patient global Phase 2/3 study with opaganib

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

(NCT04467840). Top-line results are expected in the coming weeks.

Opaganib is a novel, host-targeted, dual antiviral and anti-inflammatory

investigational pill in advanced clinical development for the treatment of

severe COVID-19. Opaganib recently demonstrated potent in vitro inhibition of

the Beta (South African) and Gamma (Brazilian) variants and based on its unique

host-targeted mechanism and the preliminary results from this study, we believe

opaganib is likely to also maintain its activity against emerging variants,

including Delta and Delta Plus. Positive U.S. Phase 2 efficacy data has also

previously been announced.

"Emerging data is showing that variants are capable of evading vaccines'

effects. Not only does this threaten efforts to control the pandemic, but it

also brings into sharp focus the urgent need for effective oral COVID-19

therapies capable of working despite the emergence of variants. This makes the

completion of this study even more significant, given its potential to be a

game-changer in the treatment of COVID-19," said Mark L. Levitt, MD, Ph.D.,

Medical Director at RedHill. "We can now concentrate on getting all the data

collected, cleaned and collated in the database ready for analysis and

subsequent reporting. This means we are weeks away from knowing if we are a big

step closer to having a paradigm-shifting oral therapy for hospitalized

COVID-19 patients."

The primary endpoint of the global Phase 2/3 study, approved in 10 countries,

is the proportion of patients breathing room air without oxygen support by Day

14. The study has also captured additional important outcome measures, 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.

Evaluations of blinded blended intubation and mortality rates from the Phase

2/3 study have been encouraging 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 have been received following three unblinded safety reviews and an

unblinded futility analysis. Additionally, encouraging use of opaganib under

compassionate use exemption has been experienced in Israel and Switzerland.

The Company maintains ongoing discussions with the FDA, EMA and other

regulators, on potential pathways to approval, with next steps to 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 (ABC294640[3])

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 that has now completed patient treatment and follow-up.

Opaganib has also 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 have shown decreased fatality rates from

influenza virus infection and amelioration of Pseudomonas aeruginosa-induced

lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar

lavage fluids[4].

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® for opioid-induced constipation in

adults[5], Talicia® for the treatment of Helicobacter pylori (H. pylori)

infection in adults[6], and Aemcolo® for the treatment of travelers' diarrhea

in adults[7]. 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 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®), 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 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®; (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.

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] Yeliva remains the prospective brand name for opaganib

[4] 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.

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

www.Movantik.com.  

[6] Full prescribing information for Talicia® (omeprazole magnesium,

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

[7] Full prescribing information for Aemcolo® (rifamycin) is available at:

www.Aemcolo.com.

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SOURCE: RedHill Biopharma Ltd.