Bellus Health has registered to launch an international multi-center (including China) phase 3 clinical study.
The Zhitong Finance App learned that the official website of the China Drug Clinical Trial Registration and Information Disclosure Platform recently announced that Bellus Health has registered to launch an international multi-center (including China) phase 3 clinical study to evaluate the safety and efficacy of BLU-5937 in treating intractable chronic cough (including chronic cough of unknown cause). According to public information, BLU-5937 (camlipixant) is a selective oral P2X3 receptor antagonist. In April 2023, GlaxoSmithKline (GSK) announced that it had reached a merger and acquisition agreement with Bellus Health to acquire the latter for a total of about US$2 billion, thereby acquiring this treatment under development.
This time, the researchers initiated a 3-phase, 24-week, randomized, efficacy and safety study of camlipixant's open extended treatment in China. The main objective was to evaluate the effect of camlipixant compared with placebo on the 24-hour cough frequency of 24 hours in adult patients with RCC (including unexplained chronic cough) with a 24-hour cough frequency greater than 8 coughs/hour at baseline, and to determine the safety of treatment up to week 24. The main researchers in the study were Academician Zhong Nanshan and Chief Physician Lai Kefang of 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 clinical study to evaluate the efficacy and safety of camlipixant in adults with intractable chronic cough (including chronic cough of unknown cause). The CALM study data is expected to be available in the second half of 2025.
In a phase 2b clinical study, two dosage levels of camlipixant (50 mg and 200 mg, given twice daily) reduced the 24-hour cough frequency adjusted by 34% in patients with refractory chronic cough on the 28th day of treatment, which was clinically significant and statistically significant. Furthermore, the product is generally well tolerated, and the incidence of taste-related adverse events is low at all dosage levels.