RedHill Biopharma Announces Two New U.S. Patents Covering Opaganib for Ebola Virus and RHB-104 for Crohn's

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. (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.

NOTE: This press release, provided for convenience purposes, is a translated version of the official press release published by the Company in the English language. For full press release in English language, including the forward-looking statements disclaimer, please visit: https://ir.redhillbio.com/press-releases  

[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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