GSK halts camlipixant development for chronic cough after mixed results

GSK plc (NYSE: GSK) announced it will not advance camlipixant, a P2X3 receptor antagonist, for the treatment of refractory chronic cough (RCC) after mixed results from two phase III clinical trials.

The CALM-1 trial met its primary endpoint, showing statistically significant reductions in 24-hour cough frequency with camlipixant 50mg twice daily versus placebo at week 12. The CALM-2 trial, however, did not reach statistical significance for the same primary endpoint with the 50mg twice daily dose at week 24. The 25mg twice daily dose failed to reach statistical significance in either study.

Key secondary endpoints, including a Chronic Cough Diary measure, did not meet target thresholds in either trial. The incidence and severity of treatment-related adverse events were similar between patients receiving camlipixant and those receiving placebo across both trials.

GSK stated that the aggregate data showed limited efficacy that is "unlikely to transform patient care," and the company will not pursue further development of camlipixant in RCC. Results from the CALM phase III program will be submitted for future presentation and publication.

GSK said it will continue evaluating camlipixant in a separate phase IIb trial, called BALANCE, which is assessing the drug's efficacy and safety in adults with irritable bowel syndrome with diarrhea and irritable bowel syndrome with mixed symptoms.

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