GSK shares update on CALM-1 and CALM-2 Phase III trials for camlipixant in refractory chronic cough

GSK has shared an update on the CALM-1 and CALM-2 Phase III clinical trials, which evaluated the efficacy and safety of two doses of camlipixant, a P2X3 receptor antagonist, in adults with refractory chronic cough. Refractory chronic cough is a complex and underrecognised condition with few available treatment options.

CALM-1 met its primary endpoint, with camlipixant 50mg twice daily producing statistically significant reductions in 24-hour cough frequency against placebo at week 12. CALM-2 did not reach statistical significance on the same primary endpoint with the 50mg twice daily dose at week 24. The 25mg twice daily dose failed to achieve statistical significance in either trial. Key secondary endpoints, including a Chronic Cough Diary measure, fell short of target thresholds across both studies. The overall incidence and severity of treatment-related adverse events were broadly comparable between those receiving camlipixant and those on placebo throughout both trials.

Taking the aggregate data into account, the limited degree of efficacy observed is considered unlikely to meaningfully change the outlook for patients. As a result, GSK has elected not to pursue further development of camlipixant in refractory chronic cough. Findings from the CALM Phase III programme will be submitted for future presentation and publication to advance the wider scientific understanding of the condition.

The Phase IIb BALANCE trial will continue to assess the efficacy and safety of camlipixant in adults with irritable bowel syndrome with diarrhoea and irritable bowel syndrome with mixed bowel habits.

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Related Topics and Keywords

CALM-1, CALM-2 Phase III trials, camlipixant, GSK, refractory chronic cough