Rigel churns out another late-stage clinical failure — this time in Covid-19
In the waning days of the Covid-19 pandemic, one penny stock biotech is reporting a close miss for its sole approved drug. But alas, a close miss is still a miss.
Rigel Pharmaceuticals — a biotech with only tyrosine kinase inhibitor fostamatinib in its arsenal — reported topline results Tuesday from a Phase III Covid-19 trial in patients without respiratory failure and who had certain, “high-risk prognostic” factors. The drug is only currently indicated to treat chronic immune thrombocytopenia, a blood condition when platelets are low.
Positive results for the trial were mixed. The biotech said the trial approached statistical significance on the primary efficacy endpoint, which was the number of days on oxygen through Day 29. However, the trial did not actually meet statistical significance — the p-value came out to p=0.0603. For the most part, a statistically significant p-value is determined as p=0.05 or lower.
The study, which enrolled 280 patients, put 141 patients on the drug (twice daily for two weeks) plus standard of care, and put the remaining 139 on placebo plus standard of care. Per Rigel, the mean number of days on oxygen through Day 29 in the fostamatinib treatment arm was 6.9 days, compared to 9 days in the placebo arm.
The biotech added that pre-specified secondary endpoints favored the drug over placebo, including time in the ICU, mortality and time to sustained recovery. In terms of mortality, there were four deaths in the treatment arm versus eight in placebo — yet the p-value there was substantially higher than on the primary endpoint, at p=0.4521.
Rigel CEO Raul Rodriguez said in a statement that the biotech is encouraged by the results of the data and is currently evaluating next steps with the US Department of Defense, which had partnered with Rigel on the study.
The biotech has been familiar with setbacks — just back in June, Rigel reported another Phase III fail for fostamatinib, telling investors that the primary endpoint did not achieve statistical significance when compared to placebo. Rigel was looking to induce a durable hemoglobin response in patients with warm autoimmune hemolytic anemia, or wAIHA, in a bid to expand its drug into other disorders.
Shares of $RIGL were trading below 80 cents as of Wednesday morning.