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

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.
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