RedHill Biopharma Ltd. (Nasdaq: RDHL), a specialty biopharmaceutical company, announced that preliminary top-line 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. Patients in the study were randomized at a 1:1 ratio to receive either opaganib or placebo on top of standard-of-care and were followed up for up to 42 days post treatment initiation. The results:

• Top-line 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 (SAEs) in the opaganib treatment arm than in the placebo arm.
• The opaganib-treated arm demonstrated a consistent trend of greater improvement in reducing oxygen requirement by end of treatment on day 14 across key primary and secondary efficacy outcomes, correlating with clinical improvement as defined by the World Health Organization (WHO) ordinal scale:
  • A greater improvement in the proportion of patients reaching room air and no longer requiring oxygen support by Day 14 vs. the control arm (52.6% vs 22.2%)
  • A greater improvement in the proportion of patients with 50% reduction in supplemental oxygen by day 14 vs. the control arm (89.5% vs 66.7%)
  • A higher proportion of patients discharged by Day 14 vs the control arm (73.7% vs 55.6%)
  • A greater reduction from baseline of the median total oxygen requirement (AUC) over 14 days vs the control arm (68.0% vs 46.7%)

“We are pleased with these encouraging top-line results from our exploratory Phase 2 study which confirm opaganib’s safety and demonstrate promising signals of activity when treating patients with COVID-19 and who require oxygen support.” We are also pleased, right? This is great news and possibly a new path to a healthier future!

Stay the course, stay well, mask up, roll up your sleeve, and stay tuned!