Additional Update on COVID-19 Compassionate Use with Opaganib in Israel Provided by RedHill Biopharma - Seite 2

Opaganib was administered to the hospitalized patients in addition to standard-of-care, which included hydroxychloroquine (HCQ) as background therapy. Opaganib was well tolerated at the doses administered and no opaganib-related treatment emergent adverse events have been reported to date.

“We are very pleased with the continued clinical improvement in four of the first five COVID-19 patients treated thus far with opaganib,” said Mark L. Levitt, MD, Ph.D., Medical Director at RedHill. “We continue to work diligently to make opaganib available under compassionate use to additional hospitals and countries, and we hope to see similar clinical outcomes in additional COVID-19 patients planned to be treated with opaganib.”

To find out more about RedHill Biopharma's Expanded Access policy, please visit: www.redhillbio.com/expandedaccess.

In order to facilitate access to opaganib, various programs are currently under discussion in other countries. Following further communication with the Italian Medicines Agency (AIFA), and in line with the current global shift from compassionate use programs with COVID-19 therapeutic candidates to more rigorously-controlled studies, the compassionate use program in Italy is planned to be converted to a clinical study in order to generate more robust clinical data in a controlled setting for regulatory purposes.

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.

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 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 studies² have demonstrated that opaganib decreased fatality rates from influenza-virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury.