TEL-AVIV, Israel and RALEIGH, N.C., April 06, 2020 — RedHill Biopharma Ltd. (Nasdaq: RDHL) , 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.
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. 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.
Opaganib has undergone a Phase 1 clinical study in patients with advanced solid tumors and is currently being investigated, individually and in combination with hydroxychloroquine, in a Phase 1/2a study in advanced cholangiocarcinoma (bile duct cancer), and in a Phase 2 study in prostate cancer.
The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to U.S.-based Apogee Biotechnology Corp., including the U.S. National Cancer Institute (NCI), the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), the U.S. Department of Defense and the FDA Office of Orphan Products Development.