PR91259

TEL AVIV, Israel and RALEIGH, N.C., Aug. 23, 2021 /PRNewswire=KYODO JBN/ --

U.S. patents for opaganib combination for the treatment of Ebola virus disease

provides patent protection until 2035

Opaganib's 475-patient global Phase 2/3 study in severe COVID-19 approaching

completion with upcoming top-line results

Opaganib also undergoing two oncology Phase 2 U.S. studies as well as several

development programs for inflammatory and viral indications, including Ebola

Continued expansion of patent estate protecting RHB-104 following positive

Phase 3 study for Crohn's disease; development path to approval being explored

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

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

announced that the U.S. Patent and Trademark Office (USPTO) has issued two new

patents, one covering opaganib for treating Ebola virus disease, with patent

protection until 2035, and the other covering RHB-104 for treating bacterial

infections, with protection through 2029.

"Opaganib's potent activity against several single-stranded RNA viruses

positions it as a potential treatment for many viral diseases, including

COVID-19 and other viruses that are the origin of devastating epidemics. Ebola

virus disease remains a major risk with recent recurring outbreaks. Opaganib

has already demonstrated positive results from non-clinical studies in Ebola,

and RedHill is committed to continuing its development as a potential treatment

for this devastating disease," said Danielle T. Abramson, Ph.D., SVP, Global

Head of Intellectual Property. "In addition, we continue to evaluate the

potential development path to approval of RHB-104 for Crohn's disease."

Opaganib is also under development for COVID-19, with a 475-patient global

Phase 2/3 study in patients hospitalized with severe COVID-19 with patient

treatment and follow-up recently completed and top-line results upcoming. In

parallel, opaganib is also being studied in Phase 2 U.S. studies in

cholangiocarcinoma and prostate cancer, as well as development programs for

other indications.

The MAP US randomized, double-blind, placebo-controlled first Phase 3 study

with oral RHB-104 for Crohn's disease successfully met both its primary

endpoint and its key secondary endpoints and presented the broad benefit of

RHB-104 as an add-on therapy to standard-of-care treatments for Crohn's

disease, including anti-TNFs. Future development path to approval is being

explored.

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[1], Talicia(R) for the treatment of Helicobacter pylori (H. pylori)

infection in adults[2], and Aemcolo(R) for the treatment of travelers' diarrhea

in adults[3].

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, a first-in-class oral 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),

an oral serine protease inhibitor in a U.S. Phase 2/3 study 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, 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, without limitation, the risk that the Company's

Phase 2/3 development program evaluating opaganib will not be successful and

that the data from this clinical study will be delayed, if at all, 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; (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 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 contact (U.S.):

Bryan Gibbs

Vice President

Finn Partners

+1 212 529 2236

bryan.gibbs@finnpartners.com

[1] Full prescribing information for Movantik(R) (naloxegol) is available at:

www.Movantik.com.  

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

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

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

www.Aemcolo.com.

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Source:  RedHill Biopharma Ltd.