PR87829

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

New agreement further expands manufacturing capacity for orally-administered

opaganib following positive top-line data from its Phase 2 COVID-19 study,

progress with the ongoing global Phase 2/3 study, and amid the urgent need to

address emerging viral strains

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

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

announced a manufacturing agreement with Cosmo Pharmaceuticals NV (SIX: COPN)

("Cosmo") to further expand manufacturing capacity for opaganib (Yeliva(R),

ABC294640), to address prospective demand subsequent to potential global

emergency use authorizations.

“The growing concerns over viral mutations and the spread of new potent and

evasive viral strains have increased the dire need for new COVID-19

therapeutics.” said Reza Fathi, PhD., RedHill’s Senior VP, R&D. “We are very

pleased to expand the manufacturing capacity of opaganib with a partner of

Cosmo’s quality. Opaganib is designed to act broadly against different viral

strains irrespective of mutations in the Spike protein. Opaganib is a Phase

2/3-stage novel, orally-administered sphingosine kinase-2 (SK2) inhibitor with

demonstrated antiviral, anti-inflammatory, and anti-thrombotic activity. By

targeting SK2, a human cell component involved in viral replication

irrespective of mutations in the viral Spike protein, opaganib potentially

addresses the emergence of new strains.”  

“We are delighted to further strengthen our partnership with RedHill on

expanded opaganib manufacturing, and to play a part in trying to help alleviate

the suffering the coronavirus pandemic is causing across the world, should

opaganib be approved for use,” said Davide Malavasi, Cosmo’s Head of

Manufacturing.

The global Phase 2/3 study of opaganib in severe COVID-19 pneumonia

(NCT04467840)

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

is ongoing, with patients enrolled in more than 30 sites in multiple

countries. An interim independent Data and Safety Monitoring Board (DSMB)

futility analysis will be conducted in the coming days, evaluating data from

the first 135 subjects that have reached the primary endpoint. The study has

previously undergone two unblinded independent DSMB safety data reviews, with

unanimous recommendations to continue the study.

Preliminary data

[https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=1

78&FID=2432&PID=0&IID=19319] from a non-powered U.S. Phase 2 study of 40

hospitalized patients recently showed that opaganib was safe and demonstrated

greater improvement in reducing oxygen requirement by end of treatment on Day

14 across key primary and secondary efficacy outcomes, correlating with

clinical improvement as defined by the World Health Organization (WHO) ordinal

scale.

About Opaganib (ABC294640, Yeliva(R))

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 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  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(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 (Yeliva(R)), a first-in-class 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), a serine protease inhibitor with a planned

Phase 2/3 study in 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.

About Cosmo Pharmaceuticals

Cosmo is a specialty pharmaceutical company focused on developing and

commercializing products to treat selected gastrointestinal disorders and

improve endoscopy quality measures through aiding the detection of colonic

lesions. Cosmo has also developed medical devices for endoscopy and has

recently entered into a partnership with Medtronic for the global distribution

of GI Genius™ its artificial intelligence device for use in coloscopies and GI

procedures. Cosmo has licensed Aemcolo(R) to RedHill Biopharma for the US and

has licensed Relafalk(R) to Dr. Falk Gmbh for the EU and other countries. For

additional information on Cosmo and its products please visit the Company’s

website: www.cosmopharma.com

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, including without limitation, the risk that the agreement

with Cosmo will not provide high-quality manufacturing capacity for opaganib or

be sufficient to meet market demands; the risk that opaganib will not address

resistance due to viral mutations; the risk of delay in reporting top-line data

from the global Phase 2/3 study of opaganib in severe COVID-19 pneumonia and

the timing of global emergency us applications if at all; as well as other

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 risk

that the Company will not succeed to complete the patient recruitment of the

global Phase 2/3 study; the risk that the global Phase 2/3 clinical study

evaluating opaganib will not be successful or, if successful, will not suffice

for emergency use applications or regulatory marketing approval without the

need for additional clinical and/or other studies; (v) the manufacturing,

clinical development, commercialization, and market acceptance of the Company’s

therapeutic candidates and Talicia(R); (vi) the Company’s ability to

successfully commercialize and promote Movantik(R), Talicia(R) and Aemcolo(R);

(vii) the Company’s ability to establish and maintain corporate collaborations;

(viii) 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; (ix) 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; (x) the implementation of the Company’s business model,

strategic plans for its business and therapeutic candidates; (xi) 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; (xii) parties from whom the Company licenses its

intellectual property defaulting in their obligations to the Company; (xiii)

estimates of the Company’s expenses, future revenues, capital requirements and

needs for additional financing; (xiv) the effect of patients suffering adverse

events using investigative drugs under the Company's Expanded Access Program;

and (xv) 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 4, 2020.

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.

[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(R) (naloxegol) is available at:

www.Movantik.com.  

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

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

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

www.Aemcolo.com.

Company contact:

Adi Frish

Chief Corporate & Business Development Officer

RedHill Biopharma

+972-54-6543-112

adi@redhillbio.com

Media contact (U.S.):

Bryan Gibbs

Vice President

Finn Partners

+1 212 529 2236

bryan.gibbs@finnpartners.com

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Source: RedHill Biopharma Ltd