Country for PR: United Kingdom
Contributor: PR Newswire Europe
Monday, November 30 2020 - 09:00
RedHill Biopharma Expands U.S.-Based Manufacturing Capacity of Opaganib for COVID-19
TEL AVIV, Israel and RALEIGH, N.C., Nov. 30, 2020 /PRNewswire-AsiaNet / --

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 

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®)

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 

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 

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, a 
web-based service by the U.S. National Institute of Health, which provides 
public access to information on publicly and privately supported clinical 

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[4], Talicia® for the treatment of Helicobacter pylori (H. pylori) 
infection in adults[5], and Aemcolo® 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®), 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®), 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 

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®; (vi) the Company's 
ability to successfully commercialize and promote Movantik®, Talicia® 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 

Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma

Media contact (U.S.):
Bryan Gibbs
Vice President
Finn Partners
+1 212 529 2236

[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:

[4] Full prescribing information for Movantik® (naloxegol) is available at:   

[5] Full prescribing information for Talicia® (omeprazole magnesium, 
amoxicillin and rifabutin) is available at:       

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

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SOURCE: RedHill Biopharma Ltd.