RedHill Biopharma Announces First COVID-19 Patient Treated with Opaganib in Israel Under Compassionate Use

Compassionate use approved by Israeli Ministry of Health; Additional patients expected to be treated in the coming days

Discussions ongoing in the U.S. and other countries

TEL-AVIV, Israel and RALEIGH, N.C., April 06, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company focused on gastrointestinal diseases, today announced that the first patient with confirmed coronavirus (COVID-19) diagnosis has been dosed with the Company’s proprietary investigational new drug, opaganib (Yeliva, ABC294640)¹, at a leading hospital in Israel. The treated patient is suffering from respiratory symptoms related to COVID-19 infection. The treatment is administered under a compassionate use program in accordance with the Israeli Ministry of Health guidelines, with additional patients expected to be treated in the coming days.

A total of 131 subjects have been dosed with opaganib to date in ongoing and completed Phase 1 and Phase 2 clinical studies in oncology indications in the U.S., in pharmacokinetic studies in healthy volunteers in the U.S., and under the existing FDA-approved expanded access requests from physicians for individual oncology patients, establishing safety and tolerability in humans both in the U.S. and ex-U.S.

“The treatment of COVID-19 patients with opaganib is supported by pre-clinical data demonstrating its unique anti-viral activity in a number of other viruses, as well as its anti-inflammatory activities and potential to reduce lung inflammation. In addition, clinical data to date have indicated safety and tolerability in healthy volunteers and cancer patients,” said Mark L. Levitt, MD, Ph.D., Medical Director at RedHill. “We will closely monitor the status of the treated COVID-19 patients in collaboration with the treating physicians. In addition, we are working toward making opaganib available to additional patients in Israel and other countries under compassionate use programs.”

RedHill is also preparing for potential ramp-up of manufacturing of opaganib.

To find out more about RedHill Biopharma's Expanded Access policy, please look here for additional information: www.redhillbio.com/expandedaccess.

Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anticancer, anti-viral and anti-inflammatory activities, targeting multiple oncology, inflammatory and gastrointestinal indications. Pre-clinical data have demonstrated both anti-viral and anti-inflammatory activities of opaganib, with the potential to reduce lung inflammatory disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Several prior pre-clinical studies support the potential role of SK2 in the replication-transcription complex of positive-strand single-stranded RNA viruses, similar to coronavirus, and its inhibition may potentially inhibit viral replication. Pre-clinical in vivo studies² have demonstrated that opaganib decreased fatality rates from influenza-virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury.