GlaxoSmithKline's chronic cough therapy launched Phase 3 clinical trials in China
GlaxoSmithKline's chronic cough therapy has started Phase 3 clinical trials in China. Bellus Health has initiated a study in China to evaluate the efficacy and safety of BLU-5937 in treating refractory chronic cough. The study aims to assess the effectiveness and safety of BLU-5937 in adult patients with refractory chronic cough. This study is led by Academician Zhong Nanshan and Director Lai Kefang of the First Affiliated Hospital of Guangzhou Medical University. The company is also conducting two other clinical trials, with data expected in the second half of 2025. This news constitutes significant corporate event information
According to the Zhitong Finance and Economics APP, the official website of the China Clinical Trial Registration and Information Disclosure Platform recently announced that Bellus Health has registered and initiated an international multicenter (including China) Phase 3 clinical study to evaluate the safety and efficacy of BLU-5937 in treating refractory chronic cough (including unexplained chronic cough). Public information shows that BLU-5937 (camlipixant) is a selective oral P2X3 receptor antagonist. In April 2023, GlaxoSmithKline (GSK) announced that it had reached an acquisition agreement with Bellus Health for approximately $2 billion, acquiring the latter and obtaining this investigational therapy.
The researchers in China have initiated a Phase 3, 24-week, randomized, open-label extension study of camlipixant treatment. The main objective is to evaluate the impact of camlipixant on the 24-hour cough frequency at week 24 compared to placebo in adult patients with a baseline 24-hour cough frequency of ≥8 coughs/hour in refractory chronic cough (including unexplained chronic cough), and to determine the safety by week 24. The principal investigators of this study are Academician Zhong Nanshan and Chief Physician Lai Kefang from the First Affiliated Hospital of Guangzhou Medical University.
According to public information from GSK, the company is conducting two Phase 3 clinical studies on camlipixant. In addition to the CALM-2 study initiated in China, there is also a 52-week randomized, double-blind, placebo-controlled Phase 3 CALM-1 clinical study to evaluate the efficacy and safety of camlipixant in adult patients with refractory chronic cough (including unexplained chronic cough). Data from the CALM studies are expected to be available in the second half of 2025.
In a Phase 2b clinical study, at day 28 of treatment, camlipixant at two dose levels (50mg and 200mg, twice daily dosing) reduced the placebo-adjusted 24-hour cough frequency by 34% in patients with refractory chronic cough, with clinical significance and statistical significance. Additionally, the product generally has good tolerability, with a low incidence of taste-related adverse events at all dose levels