PR90341

TEL AVIV, Israel and RALEIGH, N.C., June 28, 2021 /PRNewswire=KYODO JBN/ --

Opaganib strongly inhibits Beta (South African) and Gamma (Brazilian) COVID-19

variants, further supporting its antiviral activity

Opaganib's unique, orally-administered, host-targeted, dual antiviral and

anti-inflammatory approach to combatting COVID-19 is also expected to maintain

effect against other emerging variants, including the Delta (Indian) variant

Completion of opaganib's global fully enrolled 475-patient Phase 2/3 study in

hospitalized patients with COVID-19 expected in the coming weeks

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

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

announced preliminary results of a new preclinical study showing potent

inhibition of COVID-19 variants of concern by opaganib (Yeliva(R),

ABC294640)[1].

RedHill Biopharma Logo (PRNewsfoto/RedHill Biopharma)

Opaganib, a leading novel investigational oral pill in development for the

treatment of COVID-19, is a unique host-targeted, dual antiviral and

anti-inflammatory drug that acts on the cause and effect of COVID-19. It exerts

its antiviral effect by selectively inhibiting sphingosine kinase-2 (SK2), a

key enzyme produced in human cells that can be recruited by the virus to

support its replication. Following the recently presented positive U.S. Phase 2

study data, opaganib's global 475-patient Phase 2/3 study in hospitalized

patients with COVID-19 is fully enrolled and is expected to be completed in the

coming weeks.

Working with the University of Louisville Center for Predictive Medicine,

opaganib was studied in a 3D tissue model of human bronchial epithelial cells

(EpiAirway(TM)) to evaluate the in vitro efficacy of opaganib in inhibiting the

Beta (South African) and Gamma (Brazilian) SARS-CoV-2 variants. Preliminary

results showed potent inhibition of both the Beta and Gamma variants by

opaganib at non-cytotoxic doses.

"The results we have seen with opaganib so far are exciting," said William

Severson, Ph.D., Director of Shared Resources for the Center for Predictive

Medicine, University of Louisville. "They provide further evidence in support

of opaganib's antiviral capabilities and highlight opaganib's potential as an

orally-administered treatment for COVID-19 and its continuously emerging

variants."

"Opaganib inhibits an enzyme in the COVID-19 patients' cells called sphingosine

kinase-2, which the SARS-CoV-2 virus can recruit in order to replicate," said

Reza Fathi, PhD., RedHill's Senior VP, R&D. "Opaganib's dual antiviral and

anti-inflammatory mechanism of action is independent of mutations in the spike

protein. This means we expect opaganib to similarly work against other emerging

COVID-19 variants, including the Delta (Indian) variant. Moreover, we are

looking forward to seeing the top-line clinical data from the global Phase 2/3

study which is expected to be completed in the coming weeks."

The global Phase 2/3 study of opaganib in COVID-19 has previously received four

independent DSMB recommendations to continue following unblinded safety reviews

and a futility review. Additionally, an evaluation of the blinded blended

intubation and mortality rates to date was encouraging as compared to reported

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

studies in similar patient populations[2].

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 is being evaluated as a treatment for COVID-19 pneumonia in a global

Phase 2/3 study, which recently completed enrollment, and has demonstrated

positive safety and efficacy signals in preliminary top-line data from the

40-patient U.S. Phase 2 study.

Opaganib demonstrated potent inhibition of viral replication against

SARS-CoV-2, the virus that causes COVID-19, 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].

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.

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[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-head 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.