RedHill Biopharma Ltd. (RDHL) said that preliminary data from its U.S. Phase 2 study with orally-administered opaganib in patients hospitalized with COVID-19 pneumonia demonstrated positive safety and efficacy signals.
The randomized, double-blind, placebo-controlled U.S. Phase 2 proof-of-concept study with opaganib enrolled 40 patients requiring oxygen support.
The results from the study found opaganib to be safe, with no material safety differences between the opaganib and placebo treatment arms.
Overall, fewer patients suffered from serious adverse events in the opaganib treatment arm than in the placebo arm. In this small sample size, there were few events of intubation or fatality and these were balanced between the two arms.
The company noted that consistent trends demonstrated greater improvement in reducing oxygen requirement by end of treatment at Day 14 in the opaganib-treated arm across key primary and secondary efficacy outcomes, correlating with clinical improvement as defined by the World Health Organization (WHO) ordinal scale.
The opaganib-treated arm demonstrated a greater improvement in reaching room air within 14 days ; greater improvement in reduction to 50% supplemental oxygen by Day 14 ; a higher proportion of patients discharged by Day 14 and a greater reduction in the median total oxygen requirement over 14 days.
The efficacy of opaganib in severe COVID-19 pneumonia is being further explored in an ongoing global Phase 2/3 study and is expected to report top-line data in the first quarter of 2021. The study (NCT04467840) is being conducted across approximately 30 clinical sites in several countries and is on track to enroll up to 270 patients.
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