GSK Update on Phase III Program for Otilimab in Moderate to Severe Rheumatoid Arthritis

 MorphoSys AG (FSE:MOR)(NASDAQ:MOR) announced today that its licensing partner, GSK plc (GSK), provided an update on the ContRAst phase III program for otilimab as a potential treatment of 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 (American College of Rheumatology criteria) 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). Data from ContRAst-3, the third trial in the program, did not demonstrate statistical significance on the primary endpoint of ACR20 response versus placebo at week 12 in patients with inadequate response to biologic DMARDs and/or Janus Kinase inhibitors.

According to GSK, assessment of efficacy and safety data from the ContRAst program is ongoing, however the limited efficacy demonstrated does not support a suitable benefit/risk profile for otilimab as a potential treatment to transform patient care for this difficult-to-treat population of RA patients. As a result, GSK has decided not to progress with regulatory submissions. GSK is planning to submit full results from the ContRAst phase III program for publication in 2023.

https://www.biospace.com/article/releases/gsk-morphosys-licensing-partner-provides-update-on-contrast-phase-iii-program-for-otilimab-in-moderate-to-severe-rheumatoid-arthritis/