A disappointing outcome for Bellus
Bellus Health is reporting negative results this morning from a mid-stage clinical trial of its experimental pill for chronic cough — a disappointing outcome that is forcing the Canadian drug maker to rethink and prolong development plans.
In the phase 2 study, the highest dose of the Bellus drug, called BLU-5937, reduced the frequency of cough by 17% compared to placebo — a difference that was not statistically significant and therefore failed to achieve the study’s main goal. Three lower doses of the drug performed even worse.
“Did we meet the expectations we set for ourselves? No, we missed the primary endpoint, let’s be honest about that," said Bellus CEO Roberto Bellini. "But I do see a path forward.”
That path might center on treating patients with higher cough counts at baseline, where BLU-5937 showed better results, but it will also require Bellus to conduct another mid-stage clinical trial instead of pushing ahead into a Phase 3 study as previously planned.
Read more.
In the phase 2 study, the highest dose of the Bellus drug, called BLU-5937, reduced the frequency of cough by 17% compared to placebo — a difference that was not statistically significant and therefore failed to achieve the study’s main goal. Three lower doses of the drug performed even worse.
“Did we meet the expectations we set for ourselves? No, we missed the primary endpoint, let’s be honest about that," said Bellus CEO Roberto Bellini. "But I do see a path forward.”
That path might center on treating patients with higher cough counts at baseline, where BLU-5937 showed better results, but it will also require Bellus to conduct another mid-stage clinical trial instead of pushing ahead into a Phase 3 study as previously planned.
Read more.
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