On Apr. 27, 2020, RedHill Biopharma provided an additional update on the compassionate use program with its investigational drug, opaganib (Yeliva, ABC294640)1), in patients with confirmed SARS-CoV-2 infection in Israel. Preliminary findings from all six patients analyzed had shown that all the patients demonstrated objective significant measurable clinical improvement within days following treatment initiation with opaganib.

Five of the six patients analyzed were weaned from oxygen, and three were discharged from the hospital within days of treatment initiation. The 6^th patient, whose therapy was initiated more recently, is improving. To date, two patients have safely completed 14 days of opaganib therapy, which has been well tolerated. A 7^th patient who was treated with hydroxychloroquine and azithromycin suffered from side effects of diarrhea, which resolved quickly following cessation of all therapies. This patient received only 1 day of opaganib dosing and therefore was not included in this analysis.

RedHill recently announced that it has submitted an Investigational New Drug (IND) application to the FDA to evaluate the safety and efficacy of opaganib in a randomized, double-blind, placebo-controlled Phase 2a study in patients hospitalized with positive SARS-CoV-2 and pneumonia in the U.S.

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 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.

Pre-clinical data have demonstrated both anti-inflammatory and anti-viral 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 sphingosine kinase-2 (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 studies³ have demonstrated that opaganib 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.