GSK updates CALM-1 and CALM-2 camlipixant phase III results
- CALM‑1: camlipixant 50 mg twice daily showed a statistically significant reduction in 24‑hour cough frequency versus placebo at week 12.
- CALM‑2: camlipixant 50 mg twice daily did not reach statistical significance for the same primary endpoint at week 24.
- Camlipixant 25 mg twice daily failed to reach statistical significance in both CALM‑1 and CALM‑2, and key secondary endpoints including the Chronic Cough Diary missed target thresholds.
- GSK will not progress camlipixant for refractory chronic cough; the phase IIb BALANCE trial in IBS‑D and IBS‑M will continue.
Trial outcomes
CALM‑1 met its primary endpoint: camlipixant 50 mg twice daily produced a statistically significant reduction in 24‑hour cough frequency versus placebo at week 12. CALM‑2 did not achieve statistical significance for the same primary endpoint with 50 mg twice daily at week 24. The 25 mg twice‑daily dose 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 trial.
Safety
Across both trials, the overall incidence and severity of treatment‑related adverse events were similar for patients receiving camlipixant and those receiving placebo.
Programme decision
On aggregate, the limited efficacy observed was judged unlikely to transform patient care; GSK has decided not to progress further development of camlipixant in refractory chronic cough. Results from the CALM phase III programme will be submitted for future presentation and publication to inform scientific understanding of RCC.
Other studies
The phase IIb BALANCE trial will continue to evaluate the efficacy and safety of camlipixant in adults with irritable bowel syndrome‑diarrhoea (IBS‑D) and irritable bowel syndrome‑mixed (IBS‑M).
Source: GSK
