GSK Pulls Plug On Late-Stage Asset Under Development For Rheumatoid Arthritis

GSK plc GSK has issued an update on the ContRAst phase 3 program for otilimab, an investigational monoclonal antibody for moderate to severe rheumatoid arthritis (RA).
The ContRAst phase IIl program enrolled a broad range of difficult-to-treat patients who had an inadequate response to or could not tolerate available treatments.
ContRAst-1 and ContRAst-2 met their primary endpoints of a statistically significant ACR20 response versus placebo at week 12 in patients with inadequate response to methotrexate (ContRAst-1) and conventional synthetic or biologic disease-modifying antirheumatic drugs (DMARDs) (ContRAst-2).
ContRAst-3's third trial in the program did not demonstrate statistical significance on the primary endpoint of ACR20 response versus placebo at week 12.
While the ContRAst-1 and ContRAst-2 trials met their primary endpoints, the efficacy demonstrated is unlikely to transform patient care for this difficult-to-treat patient population.
GSK said that the limited efficacy demonstrated does not support a suitable benefit/risk profile for otilimab as a potential treatment for RA.
Hence, GSK has decided not to progress with regulatory submissions. Full results from the ContRAst phase 3 program will be submitted for publication in 2023.
Price Action: GSK shares are down 0.12% at $32.66 during the premarket session on the last check Thursday.