RedHill Biopharma has presented phase 2 data on opaganib in COVID-19 patients on supplemental oxygen. The 40-subject trial linked the oral SK2 inhibitor to a numerical improvement in total oxygen requirement but was too small to provide conclusive answers.
Investigators randomized 40 COVID-19 patients who developed pneumonia and required oxygen to receive opaganib or placebo twice a day for 14 days in addition to standard of care. The primary endpoint compared the total oxygen requirements of participants in the two arms over the duration of the treatment period.
RedHill reported a 68% reduction in the median total oxygen requirement of patients on opaganib, as compared to a 46.7% reduction in the placebo cohort. The statement to disclose the results lacked a statistical analysis of the data. RedHill said the trial was non-powered.
Other endpoints discussed by RedHill in the release favored opaganib numerically. By Day 14, 73.7% of patients on opaganib had been discharged, versus 55.6% in the control arm group. RedHill also linked its drug to greater improvements in reaching room air and reduction to 50% supplemental oxygen.
The statement released by RedHill only covers some of the endpoints listed in the outcome measures for the study on ClinicalTrials.gov. Day 14 outcomes absent from the statement include mechanical ventilation endpoints. The statement also lacks 30-day mortality data.
RedHill is still reviewing and analyzing data from the phase 2, but the design of the clinical trial means there will be limitations to what conclusions can be drawn even once all the results are available to the public. Results from a larger trial are needed to make more concrete conclusions.
Recognizing that, RedHill began a 270-subject phase 2/3 clinical trial shortly after starting the smaller study in the summer. Top-line results from the larger clinical trial are due in the first quarter. The primary endpoint of the phase 2/3 is the proportion of patients requiring intubation and mechanical ventilation. RedHill’s phase 2 statement lacked data on intubation and mechanical ventilation.
The only reference to intubation or mechanical ventilation in the statement was in relation to safety. RedHill said “there were few events of intubation or fatality and these were balanced between the two arms.” Other safety events were also balanced between the two arms.