GSK's $2 Billion Acquisition Yields Chronic Cough Therapy Now in Phase 3 Trials in China

▎Edited by the WuXi AppTec content team

Screenshot source:China Drug Clinical Trial Registration and Information Disclosure Platform Official Website

Refractory Chronic Cough (RCC) is defined as a persistent cough lasting more than 8 weeks, with no response to treatment of the underlying cause or being unexplained.A study published in a leading journal in the field of respiratory diseasesEuropean Respiratory JournalThe research shows,The prevalence of chronic cough (lasting more than 8 weeks) is approximately 10% among adults globally.。RCC severely affects the quality of life, and patients may experience depression, urinary incontinence, pain, rib fractures, social withdrawal, and insomnia.

P2X3 receptor, a member of the purinergic receptor family, is a non-selective ligand-gated ion channel.Recent studies have found that the overactivation of P2X3 receptors is associated with the hypersensitization of sensory neurons, and that airway and lung neuron hypersensitivity caused by injury or infection can lead to excessive, persistent, and frequent coughing.P2X3 Receptor AntagonistBy antagonizing P2X3 receptors located on primary afferent neurons, the excitability of afferent nerves is reduced to suppress cough., and is expected to achieve the efficacy of antitussive without affecting the central nervous system.

CamlipixantIt is a highly selective and potent P2X3 receptor antagonist. Clinical data show that by selectively inhibiting the P2X3 receptor,This product can reduce the risk ofRefractory Chronic CoughThe frequency of patients' cough, and the incidence of drug-related adverse events causing taste disorders is relatively low.This adverse reaction is common in other drugs that broadly target the P2X2/3 receptors. The adverse reaction of taste disturbance often leads to patients discontinuing treatment.

The research personnel initiated acamlipixantOpen ExtensionTreatmentTherapeutic3Period, 24 weeks, randomized、Efficacy and Safety Research。The main purpose isEvaluationcamlipixantCompared with placebo, in adult patients with RCC (including unexplained chronic cough) who have a baseline 24-hour cough frequency ≥8 coughs/hour,Week 24Impact on 24-hour cough frequency and assessment of safety up to Week 24 of treatment。The principal investigator of this study is from the First Affiliated Hospital of Guangzhou Medical University.Academician Zhong NanshanAndDr. Laikfang Lai。

According to publicly available information from GSK, the company is currently targetingcamlipixantTwo Phase 3 clinical trials have been initiated, in addition to the one launched in China this time.CALM-2 Study,There is another itemLasting 52 weeksRandomized, Double-blind,Placebo-Controlled Phase 3CALM-1 Clinical StudyTo evaluate the efficacy and safety of camlipixant in adult patients with refractory chronic cough (including chronic cough of unknown cause).CALM Study DataExpected to be obtained in the second half of 2025。

In a Phase 2b clinical study, on Day 28 of treatment,camlipixantTwo dose levels (50mg and 200mg, administered twice daily)Refractory Chronic CoughPatientThe 24-hour cough frequency decreased by 34% after placebo adjustment., which is clinically meaningful and statistically significant. In addition, the product is generally well-tolerated with a low incidence of taste-related adverse events across all dose levels.

[2] GSK reaches agreement to acquire late-stage biopharmaceutical company BELLUS Health. Retrieved April 18, 2023 from https://www.gsk.com/en-gb/media/press-releases/gsk-reaches-agreement-to-acquire-late-stage-biopharmaceutical-company-bellus-health/

[3] BELLUS Health Announces Positive Topline Results from its Phase 2b SOOTHE Trial of BLU-5937 for the Treatment of Refractory Chronic Cough. Retrieved December 13, 2021, from https://ir.bellushealth.com/news-releases/news-release-details/bellus-health-announces-positive-topline-results-its-phase-2b

[4]GSK completes acquisition of BELLUS Health. Retrieved Jun 28 , 2023. From  https://www.gsk.com/en-gb/media/press-releases/gsk-completes-acquisition-of-bellus-health/