The US FDA has approved an IND for a randomised, double-blind, placebo-controlled Phase IIa clinical study evaluating RedHill Biopharma‘s opaganib (Yeliva®, ABC294640) in 40 hospitalised patients with confirmed moderate-to-severe SARS-COV-2 infection. The primary objective will be to evaluate the reduction in total oxygen requirement over the course of treatment for up to 14 days. Secondary endpoints include time to 50% reduction in oxygen requirements, the proportion of patients without fever at Day 14, and proportion with negative nasal swabs at Day 14. This trial is not powered for statistical significance.
The company has also reported positive preliminary results from a trial in Israel in six moderate-to-severe COVID-19 patients treated with opaganib under compassionate use, with all patients demonstrating both subjective and objective significant measurable clinical improvement within days following treatment initiation, including decreased required supplemental oxygenation, higher lymphocyte counts and decreased C-reactive protein (CRP) levels. All six patients were weaned from oxygen and discharged from the hospital. Opaganib was well tolerated and showed clinical improvement both with and without hydroxychloroquine. At the time of treatment initiation, all of the patients were hospitalised, were hypoxic, and required supplemental oxygen while being treated with standard-of-care, mostly hydroxychloroquine.
Dr Mark Levitt, Medical Director, RedHill, said: “There is a strong scientific rationale for the potential efficacy of opaganib in the treatment of COVID-19, including preclinical 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. This is coupled with encouraging preliminary data from the compassionate use program in Israel.”
A total of 139 subjects have been dosed with opaganib to date in ongoing and completed Phase I and Phase II clinical studies in oncology indications, in pharmacokinetic studies in healthy volunteers in the US, 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.
Link to Press Release.