PR86922

TEL AVIV, Israel and RALEIGH, N.C., Nov. 30, 2020 /PRNewswire=KYODO JBN/ --

RedHill adds two more manufacturing partners, both U.S.-based, for large-scale

manufacturing of opaganib, in preparation for potential emergency use

applications as early as Q1/2021

The new collaborations follow recently announced collaborations with European

and Canadian manufacturers

U.S. Phase 2 study fully enrolled – top-line data expected in the coming weeks;

parallel global Phase 2/3 study more than 50% enrolled – top-line data expected Q1/2021

Opaganib's promising novel mechanism of action potentially minimizes likelihood

of resistance due to viral mutations

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

biopharmaceutical company, today announced partnerships with two leading,

U.S.-based manufacturers for large-scale manufacturing of opaganib[1]. These

collaborations further advance ongoing preparations to support potential

emergency use applications for opaganib to treat severe COVID-19 pneumonia,

expected as early as the first quarter of 2021. The new collaborations follow

recently announced collaborations with European and Canadian manufacturers.

"We are expanding our U.S.-based manufacturing capacity for orally administered

opaganib, ahead of potential emergency use applications as early as Q1/2021,"

said Reza Fathi, PhD., RedHill's Senior VP, R&D. "Together with our recently

announced similar partnerships in Europe and Canada and in light of our rapidly

progressing Phase 2/3 opaganib COVID-19 program, these new U.S. partnerships

better place RedHill to meet potential demand for opaganib, if approved."

Opaganib is a novel, orally administered, sphingosine kinase-2 (SK2) selective

inhibitor with demonstrated dual anti-inflammatory and antiviral activity that

acts on the cause and effect of  COVID-19 disease, targeting a host cell

component involved in viral replication, potentially minimizing likelihood of

resistance due to viral mutations.

Enrollment in the 270-patient global Phase 2/3 study with opaganib in patients

with severe  COVID-19 pneumonia (NCT04467840) is more than 50% complete. The

study is approved in six countries and is on track to deliver top-line data in

the first quarter of 2021. This study is focused on and powered for efficacy

evaluation, and recently received a unanimous recommendation to continue by an

independent Data and Safety Monitoring Board (DSMB), following a pre-scheduled

safety review of the first 70 patients to have been treated for 14 days. A

prescheduled, unblinded futility interim analysis will also be conducted by the

DSMB in the coming weeks, evaluating data from the first 135 subjects that have

reached the primary endpoint.

The parallel U.S. Phase 2 study with opaganib (NCT04414618) has completed

enrollment of all 40 subjects, with topline data expected in the coming weeks.

This study is not powered for efficacy and is focused on safety evaluation and

identification of efficacy signals.

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, potentially minimizing the likelihood for resistance due to viral

mutations. Opaganib has also shown anticancer activity and has the potential to

target multiple oncology, viral, inflammatory and gastrointestinal indications.

Opaganib is being evaluated in a global Phase 2/3 study and a U.S. Phase 2

study for the treatment of severe COVID-19 pneumonia. Opaganib 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.

Preclinical data have demonstrated both anti-inflammatory and antiviral

activities of opaganib, with the potential to reduce 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. 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.

Under a compassionate use program, patients with severe COVID-19 (as classified

by the WHO ordinal scale) were treated with opaganib in a leading hospital in

Israel. Data from the treatment of these first patients with severe COVID-19

with opaganib have been published[3]. Analysis of treatment outcomes suggest

substantial benefit to patients treated with opaganib under compassionate use

in both clinical outcomes and inflammatory markers as compared to a

retrospective matched case-control group from the same hospital. All patients

in the opaganib-treated group were discharged from hospital on room air without

requiring intubation and mechanical ventilation, whereas 33% of the matched

case-control group required intubation and mechanical ventilation. Median time

to weaning from high-flow nasal cannula was reduced to 10 days in the

opaganib-treated group, as compared to 15 days in the matched case-control group.

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[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) ), 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-104, with positive results from a first Phase 3 study for

Crohn's disease; (iv) 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; (v) RHB-107 (upamostat), a Phase 2-stage serine protease

inhibitor with a planned Phase 2/3 study in symptomatic COVID-19 and targeting

multiple other cancer and inflammatory gastrointestinal diseases;  and (vi)

RHB-106, an encapsulated bowel preparation. More information about the Company

is available at www.redhillbio.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 and include statements regarding the

timing of the reporting of data from the U.S. Phase 2 trial evaluating

opaganib, the timing, if at all, of potential emergency use applications of

opaganib and reporting of data, from the global Phase 2/3 study with opaganib

and regarding the planned Phase 2/3 study for RHB-107 in symptomatic COVID-19

patients. 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, without limitation, the risk that the Company's Phase 2/3 study

evaluating opaganib will not be completed or successful; the risk of a delay in

receiving data from the Phase 2/3 study with opaganib or delay in making

emergency use applications, if at all; the risk that the U.S. Phase 2 clinical

study evaluating opaganib will not be successful and the risk that the

reporting of data from this clinical study will be delayed if at all; the risk

that the planned Phase 2/3 study for RHB-107 in symptomatic COVID-19  patients

will not occur, will be delayed or will not be completed or successful; the

risk that other COVID-19 patients treated with opaganib or RHB-107 will not

show any or insufficient clinical improvement; the development risks of

early-stage discovery efforts for a disease that is still little understood,

including difficulty in assessing the efficacy of opaganib and RHB-107 for the

treatment of COVID-19, if at all; intense competition from other companies

developing potential treatments and vaccines for COVID-19; the effect of a

potential occurrence of patients suffering serious adverse events using

opaganib under compassionate use programs; the risk that the ongoing Phase 3

study for pulmonary nontuberculous mycobacteria (NTM) disease will be delayed,

not be completed, or will not be successful, 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 lack of sufficient financial resources which may result

in material adverse impact on the Company's research, manufacturing,

preclinical studies, clinical trials, and other therapeutic candidate

development activities including delay or termination of preclinical or

clinical activities or of any other such activities (iii) the Company's ability

to advance its therapeutic candidates into clinical trials or to successfully

complete its preclinical studies or clinical trials (iv) 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; (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®; (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.

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

[1] Opaganib (Yeliva, ABC294640) is an investigational new drug, not

commercially available

[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] Kurd R, Ben-Chetrit E, Karameh H, Bar-Meir M, Compassionate Use of Opaganib

For Patients with Severe COVID-19. medRxiv 2020.06.20.20099010; doi:

https://doi.org/10.1101/2020.06.20.20099010

[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.