GSK on Thursday said it has decided to shelve plans to seek approval of an experimental drug in rheumatoid arthritis after results from a Phase 3 trial fell short of its study goals.
The British drugmaker had been preparing to file an approval application for the drug, called otilimab, next year after positive results in two prior studies. GSK licensed the antibody drug from Morphosys in 2013 and, since then, it’s become a top prospect for the company, which previously forecast future peak yearly sales of between 1 billion and 2 billion pounds.
Otilimab targets a pro-inflammatory cytokine that is thought to play a key role in autoimmune diseases like rheumatoid arthritis. Several other drugs that target the same cytokine are in development.
In 2018, however, otilimab failed to meet its primary goal in a Phase 2 trial. While the drug did not provide a statistically significant benefit versus placebo, GSK emphasized “marked” improvements in some patients and continued to study the drug candidate. (Otilimab was also tested against COVID-19, but failed a Phase 2 study.)
In the Phase 3 arthritis study that’s now read out results, otilimab did not show any statistical significance on its primary endpoint versus placebo. GSK said the drug had “limited efficacy” and did not provide a “suitable benefit/risk profile,” in treating patients with rheumatoid arthritis.
Many other drugs for rheumatoid arthritis are already on the market, raising the bar for success for drugs like otilimab.
GSK has taken other recent hits to its pipeline. On Wednesday, the company received a mixed FDA panel vote on its anemia drug candidate daprodustat, and recently ended two of its cell therapy alliances.
Shares in the drugmaker were trading around $32 apiece on the New York Stock Exchange Thursday.