Bellus Phase 2 chronic cough trial did not achieve statistical significance

Bellus Health announced topline results from its Phase 2 RELIEF trial of BLU-5937 in patients with refractory chronic cough. The trial did not achieve statistical significance for the primary endpoint of reduction in placebo-adjusted cough frequency at any dose tested, the company said. A clinically meaningful and highly statistically significant placebo-adjusted reduction in cough frequency was achieved in a pre-specified sub-group of high cough count patients, it added. BLU-5937 was also observed to be well tolerated with no serious adverse events reported and no withdrawals due to treatment-related adverse events at any dose, according to Bellus. “In the RELIEF trial, we observed data that we believe is competitive within the P2X3 class, including the reduction in cough frequency shown in patients with higher cough counts and a low taste effect. While we had hoped to see more response in the lower cough patients, BLU-5937 and other P2X3 antagonists may have the most benefit in patients with a greater disease burden,” said Roberto Bellini, CEO of Bellus. “We believe the Phase 2 data support moving BLU-5937 forward into an adaptive Phase 2b trial enriched for higher cough count patients. We expect to begin this trial in the fourth quarter of 2020.”