- GSK plc (NYSE: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.
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