GSK (NYSE:GSK) on Thursday said that it will not proceed with regulatory submissions for otilimab to treat moderate to severe rheumatoid arthritis (RA) after the drug failed to meet the main goal of a trial.
The British pharma giant added that data from the third trial, dubbed ContRAst-3, did not show statistical significance on the main goal of ACR20 response, compared to placebo at week 12 in patients with inadequate response to biologic disease modifying antirheumatic drugs (DMARDs) and/or Janus Kinase inhibitors.
ACR20 is a composite tool which requires at least a 20% improvement in certain core symptoms and measures for the patient.
Studies, ContRAst-1 and ContRAst-2 had met their main goals 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 (DMARDs) (ContRAst-2), the company noted.
GSK said that while these two studies met their main objectives, the efficacy shown was unlikely to transform patient care for this patient population.
The company added that the limited efficacy does not support a suitable benefit/risk profile for otilimab as a potential therapy for RA, thus it has decided not to progress with regulatory submissions.
GSK noted that evaluation of efficacy and safety data from the ContRAst program is ongoing, and full results from the ContRAst phase 3 program will be submitted for publication in 2023.
The ContRAst phase 3 program was aimed to compare the efficacy and safety of two doses of otilimab (90mg and 150mg subcutaneous weekly injection) with placebo, tofacitinib, sold as Xeljanz by Pfizer (PFE) (5mg capsules twice daily) and sarilumab, sold as Kevzara by Sanofi (SNY) and Regeneron (REGN) (200mg subcutaneous injection every other week), all in combination with methotrexate or conventional DMARDs.
GSK noted that it had taken up exclusive worldwide responsibility of otilimab from MorphoSys (MOR) (OTCPK:MPSYF) in 2013 for all development and commercialization activities in all therapeutic fields.