GSK plc (NYSE:GSK) on Friday announced a pivotal update regarding its Phase 3 clinical program for camlipixant, revealing a strategic decision to halt further development for refractory chronic cough (RCC).
The decision follows inconsistent data from two late-stage trials, which indicated that the medication's limited effectiveness would likely fail to significantly improve current standard care for the complex condition.
Mixed Results From Phase 3 CALM Trials The UK pharmaceutical giant evaluated the safety and efficacy of two distinct doses of camlipixant, a P2X3 receptor antagonist, across its CALM-1 and CALM-2 Phase 3 studies.
The trials yielded contrasting outcomes for the higher dose of the medication.
In the CALM-1 study, a 50mg twice-daily dose successfully achieved its primary goal, demonstrating a statistically meaningful reduction in 24-hour cough frequency compared to a placebo after 12 weeks of treatment.