
UK pharma major GSK (LSE: GSK) today provided an update on the CALM-1 and CALM-2 Phase III clinical trials, which assessed the efficacy and safety of two doses of camlipixant (a P2X3 receptor antagonist) in adults with refractory chronic cough (RCC). RCC is a complex and under-recognised disease with limited treatment options.
CALM-1 met its primary endpoint with camlipixant 50mg twice daily showing statistically significant reductions in 24-hour cough frequency versus placebo at week 12. However, CALM-2 did not reach statistical significance in the same primary endpoint with 50mg twice daily at week 24. Camlipixant 25mg twice daily did not reach statistical significance in either study. Key secondary endpoints, including a chronic cough diary (CCD) measure, did not meet target thresholds in either study. Across both trials, the overall incidence and severity of treatment-related adverse events were similar in patients receiving either camlipixant or placebo.
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