GSK Decides Not To Progress With Submissions For Otilimab In Treatment Of Rheumatoid Arthritis

(RTTNews) - GSK plc (GSK.L, GSK) issued an update on the ContRAst phase III programme for otilimab, an investigational monoclonal antibody targeting granulocyte-macrophage colony-stimulating factor, in the potential treatment of moderate to severe rheumatoid arthritis. 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, the company said. As the limited efficacy demonstrated does not support a suitable benefit/risk profile for otilimab, GSK has decided not to progress with regulatory submissions.

The company noted that the data from ContRAst-3, the third trial in the programme, did not demonstrate statistical significance on the primary endpoint of ACR201 response versus placebo at week 12 in patients with inadequate response to biologic DMARDs and/or Janus Kinase inhibitors.

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