PR88619

TEL AVIV, Israel and RALEIGH, N.C., March 22, 2021 /PRNewswire=KYODO JBN/ --

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

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

announced that it has acted on a request to provide opaganib[1] treatment on an

outpatient basis under compassionate use exemption for several Swiss patients

suffering from COVID-19 pneumonia.

Acting rapidly to ensure emergency transport and supply of drug, treatment was

initiated with orally-administered opaganib within the past week. Opaganib is a

novel, orally-administered sphingosine kinase-2 (SK2) inhibitor with

demonstrated dual anti-inflammatory and antiviral activity, targeting a human

cell component involved in viral replication and therefore expected to be

effective against emerging viral variants with mutations in the spike protein.

Gilead Raday, RedHill's Chief Operating Officer, said: "We continue to do all

we can to support patients, and their treating physician, who are in need of

treatment options for COVID-19. Having recently reported positive Phase 2 data

with opaganib in the U.S., our ongoing global 464-patient Phase 2/3 study with

opaganib for severe COVID-19 is now more than two thirds enrolled."

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 advancing in a total of eight countries and 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=1

78&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.

Preclinical data have demonstrated anti-inflammatory, antiviral and

anti-thrombotic activities of opaganib, with the potential to ameliorate

inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic

damage. 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. Opaganib also demonstrated reduced

blood clot length, weight and total thrombus score in a preclinical model of

Acquired Respiratory Distress Syndrome.

Additionally, preclinical in vivo studies[2] have demonstrated that opaganib

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.

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® for opioid-induced constipation in

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

infection in adults[4], and Aemcolo® 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®, 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 risk 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® (naloxegol) is available at:

www.Movantik.com.  

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

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

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

www.Aemcolo.com.

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Source: RedHill Biopharma Ltd.