PR91338

TEL AVIV, Israel and RALEIGH, N.C., Aug. 26, 2021 /PRNewswire=KYODO JBN/

Opaganib demonstrated strong inhibition of COVID-19 Delta variant in a human

bronchial epithelial cells model, adding to prior data demonstrating potent

inhibition of all COVID-19 variants tested to date  

Opaganib's unique, host-targeted, dual antiviral and anti-inflammatory approach

to combatting COVID-19 is expected to maintain effect against other emerging

variants

The global 475-patient Phase 2/3 study with opaganib oral pill in hospitalized

COVID-19 patients has completed treatment and follow up phase, with top-line

results upcoming

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 strong

inhibition by opaganib (ABC294640)[1] of Delta variant replication while

maintaining cell viability at relevant concentrations.

Working with the University of Louisville Center for Predictive Medicine,

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

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

Delta (Indian) variant. This work adds to the previously reported work that

showed opaganib also inhibits Alpha (Washington), Beta (South African) and

Gamma (Brazilian) SARS-CoV-2 variants.

"There is growing evidence in support of the possible key role played by

sphingosine kinase-2 in the replication of RNA viruses such as SARS-CoV-2,

irrespective of mutations at the spike protein. This makes inhibition of this

intra-cellular enzyme a promising therapeutic target for treating COVID-19

disease," said Reza Fathi, PhD., RedHill's Senior VP, R&D. "We have now

accumulated extensive evidence from our preclinical work of opaganib's potent

ability to inhibit SARS-CoV-2 variants of concern, such as Delta, and expect

that to extend to new emerging variants. The strong antiviral and

anti-inflammatory activities of oral opaganib potentially address both the

viral cause and inflammatory effects of COVID-19."

Opaganib, a leading novel small molecule 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 is believed to exert its antiviral effect by selectively

inhibiting sphingosine kinase-2 (SK2), a key enzyme produced in human cells

that may be recruited by the virus to support its replication. Opaganib's

global 475-patient Phase 2/3 study in hospitalized patients with COVID-19 has

completed its treatment and follow up phase, and study top-line results are

upcoming.

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, the opaganib Phase 2/3 study has also passed four

Data Safety Monitoring Board reviews, including a futility review, and extends

the total opaganib safety database to more than 460 patients. Opaganib

previously delivered positive U.S. Phase 2 data in patients with severe

COVID-19, presented in June at the World Microbe Forum (WMF) 2021.

Additionally, encouraging use of opaganib under compassionate use exemption has

been experienced in Israel and Switzerland.

About Opaganib (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. Opaganib is host-targeted and is

expected to be effective against emerging viral variants, having already

demonstrated strong inhibition against variants of concern, including Delta.

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 completed patient treatment and follow-up, with

top-line results upcoming. Opaganib previously delivered positive U.S. Phase 2

data in patients with severe COVID-19, presented in June at the World Microbe

Forum (WMF) 2021.

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, 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[3].

The ongoing clinical 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, Talicia(R) for the treatment of Helicobacter pylori (H. pylori)

infection in adults, and Aemcolo(R) for the treatment of travelers' diarrhea in

adults. 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 oral

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-107 (upamostat), an oral 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 ,

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(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.

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Source - RedHill Biopharma Ltd.