AsiaNet 89743

TEL AVIV, Israel and RALEIGH, NC, May 26, 2021 /PRNewswire=KYODO JBN/ --

- The two patents protect opaganib and RHB-107 for the treatment of COVID-19

until at least 2041 once granted

- Enrollment in opaganib's global Phase 2/3 study in hospitalized patients with

severe COVID-19 is almost 100% complete

- RHB-107's ongoing Phase 2/3 study is enrolling U.S. non-hospitalized patients

with symptomatic COVID-19 that do not require supplemental oxygen

- Opaganib and RHB-107 are novel, oral, host-targeted drug candidates expected

to be effective against emerging viral variants

Opaganib and RHB-107 potentially cover the vast majority of affected COVID-19

patients

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

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

announced receipt of two Notices of Allowance from the U.S. Patent and

Trademark Office (USPTO) covering opaganib[1] and RHB-107 (upamostat)[2] as

methods for the treatment of COVID-19 caused by the SARS-CoV-2 virus.

RedHill Biopharma logo

Both opaganib and RHB-107 are novel COVID-19 therapeutic candidates, in oral

pill form, with dual mechanism of action effects. Both are host-targeted and

are therefore expected to be effective against emerging viral variants with

various mutations in the spike protein.

"There is an urgent need for oral COVID-19 treatments for patients inside and

outside of the hospital setting," said Danielle T. Abramson, Ph.D., VP,

Intellectual Property & Research at RedHill. "With two novel oral COVID-19

therapeutics in late clinical-stage development, RedHill stands at the

forefront of research for COVID-19 treatments. We are very pleased with the new

intellectual property protection which extends until at least 2041. The Company

has also filed for protection under the Patent Cooperation Treaty (PCT) and has

the option of applying in the member countries thereof."

Enrollment in opaganib's global Phase 2/3 study in hospitalized patients with

severe COVID-19 (NCT04467840)[

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

] is almost 100% complete. RHB-107's Phase 2/3 study is ongoing in

non-hospitalized patients with symptomatic COVID-19 (NCT04723527)[

https://clinicaltrials.gov/ct2/show/NCT04723537 ] who do not require

supplemental oxygen. Together, this covers potential treatment for the vast

majority of affected patients.

In view of the upcoming completion of enrollment, RedHill is evaluating the

regulatory path for opaganib with a focus on those countries currently most

affected by COVID-19. The regulatory path, including potential submissions of

emergency use applications in those countries, is subject to whether the data

generated by the ongoing Phase 2/3 study is sufficiently positive and

supportive as well as the specific requirements in each country. The strength

of the safety and efficacy data generated from the opaganib studies will be key

to regulatory applications. Additional studies to support the potential of such

applications and the use or marketing of opaganib are likely to be required.

For example, the FDA has indicated we will need to complete additional studies

to support applications in the U.S. Evaluations and discussions continue with

the FDA, EMA and regulators in other countries.

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 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 is 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.

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, completely 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 has shown 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[3].

Originally developed by Apogee Biotechnology Corp., opaganib's development 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 RHB-107 (upamostat)

RHB-107 is a proprietary, first-in-class, orally-administered potent inhibitor

of several serine proteases, with antiviral and potential tissue-protective

effects. RHB-107 targets human cell factors involved in preparing the spike

protein for viral entry into target cells and is therefore expected to be

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

RHB-107 is being evaluated in a U.S. Phase 2/3 study for treatment of

non-hospitalized patients with symptomatic COVID-19 who do not require

supplemental oxygen. In addition, RHB-107 has potential in targeting cancer,

inflammatory lung diseases and gastrointestinal diseases. RHB-107 has undergone

several Phase 1 studies and two Phase 2 studies, demonstrating its clinical

safety profile in approximately 200 patients. RedHill acquired the exclusive

worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from

Germany's Heidelberg Pharmaceuticals (FSE: HPHA) (formerly WILEX AG) for all

indications.

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), 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(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.          

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 of a delay in completion of enrollment for

the Phase 2/3 COVID-19 study for opaganib and the Phase 2/3 COVID-19 study for

RHB-107, 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 and the Phase 2/3 COVID-19 study

for RHB-107 may not be successful and, even if successful, such studies 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, and for RHB-107 may be required, by

regulatory authorities to support such potential applications and the use or

marketing of opaganib and/or RHB-107, as the case may be, for COVID-19

patients, that opaganib and RHB-107 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] RHB-107 (upamostat) is an investigational new drug, not available for

commercial distribution.

[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.

[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.