RedHill Biopharma bagged approval from USFDA for its Investigational New Drug (IND) application for a Phase 2a clinical study to test its investigational drug, opaganib in patients with confirmed moderate-to-severe SARS-CoV-2 infection (the cause of COVID-19).
Kevin Winthrop, Professor of Infectious Diseases and Public Health at the OHSU-PSU School of Public Health and Principal Investigator of the study, said opaganib offered to hospitalized patients as part of a clinical study and should meet the strong unmet need for treatments to decrease the severity and duration of respiratory symptoms due to COVID-19.
Mark L. Levitt, Medical Director at RedHill, said there is a strong scientific rationale for the potential efficacy of opaganib in the treatment of COVID-19, including pre-clinical data demonstrating that opaganib may inhibit viral replication and reduce levels of IL-6 and TNF-alpha, important mediators of inflammation that are elevated in moderate-to-severe COVID-19 patients.
Levitt said that this is coupled with encouraging preliminary data from the compassionate use program in Israel, which demonstrated objective measurable clinical improvement in all six patients analyzed, including a decrease in required supplemental oxygenation, higher lymphocyte counts, and decreased CRP levels.
A total of 139 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., under the existing FDA-approved expanded access requests from physicians for individual oncology patients and under expanded access for COVID-19 patients in Israel, establishing safety and tolerability in humans both in the U.S. and ex-U.S, said RedHill in a press release.