GSK to skip regulatory submissions for its investigational drug | The Financial Express

GSK to skip regulatory submissions for its investigational drug

Rheumatoid Arthritis (RA) is a chronic, systemic inflammatory condition characterised by pain, joint swelling, stiffness, joint destruction and disability.

GSK to skip regulatory submissions for its investigational drug
The drug is currently not currently approved for use anywhere in the world. (File)

Pharma major GSK on Thursday said that it has decided to not progress with the regulatory submissions for its investigational monoclonal antibody, otilimab.

While announcing an update on the ContRAst phase III programme for the drug in the potential treatment of moderate to severe rheumatoid arthritis (RA), the pharma company said that did not demonstrate statistical significance on the primary endpoint as per the data from ContRAst-3.

“ContRAst-1 and ContRAst-2 met their primary endpoints of a statistically significant ACR20[1] response versus placebo at week 12 in patients with inadequate response to methotrexate (ContRAst-1) and conventional synthetic or biologic disedisease-modifyingirheumatic drugs (DMARDs) (ContRAst-2). Data from ContRAst-3, the third trial in the programme, did not demonstrate statistical significance on the primary endpoint of ACR20[1] response versus placebo at week 12 in patients with inadequate response to biologic DMARDs and/or Janus Kinase inhibitors,” the company said on Thursday.

According to the company, 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.

“Assessment of efficacy and safety data from the ContRAst programme is ongoing, however, the limited efficacy demonstrated does not support a suitable benefit/risk profile for otilimab as a potential treatment for RA. As a result, GSK has decided not to progress with regulatory submissions,” the company stated.

Meanwhile, the pharma major also informed that the full results from the ContRAst phase III programme will be submitted for publication in 2023. The drug is currently not currently approved for use anywhere in the world.

Rheumatoid Arthritis (RA) is a chronic, systemic inflammatory condition characterised by pain, joint swelling, stiffness, joint destruction and disability. According to studies, it is estimated that the disease affects 24.5 million people across the world.

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First published on: 27-10-2022 at 15:02 IST