GSK moved to stop work on camlipixant for refractory chronic cough after mixed Phase 3 results undermined the drug’s late-stage momentum. In the Calm-1 and Calm-2 trials, the 50 mg twice-daily regimen met the primary endpoint at week 12, but failed to reproduce results at week 24 in Calm-2, while the 25 mg dose failed to achieve success in either study. Key secondary endpoints did not reach RCC thresholds, and treatment-emergent adverse events were broadly similar to placebo. GSK’s decision closes a development path acquired via Bellus Health in 2023, a deal once framed as a way to build a respiratory franchise. The termination also shifts competitive dynamics by clearing room for Trevi Therapeutics’ Haduvio (oral nalbuphine ER) after Trevi reported positive Phase 2 data earlier this year. The action underscores how endpoint reproducibility and dose consistency remain make-or-break for P2X3 antagonist programs. It also funnels GSK’s near-term respiratory focus toward remaining studies, including an active Phase 2 program in irritable bowel syndrome. For the sector, the move is a reminder that even statistically significant early reads may not be sufficient if later timepoints and secondary measures miss—particularly in symptomatic indications where timing and adherence can influence diary-based outcomes.
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