GSK Subsidiary Bellus Health Submits IND Application in China for Camlipixant (BLU-5937), a Selective P2X3 Antagonist for Refractory Chronic Cough

On April 26, the CDE website showed that camlipixant (BLU-5937), a P2X3 antagonist developed by Bellus Health, a subsidiary of GSK, had been submitted for clinical trials in China. The company was acquired by GSK last week for a total deal value of $2 billion (see: ).

Camlipixant is a highly selective P2X3 receptor antagonist with best-in-class potential, currently in Phase III clinical trials for the first-line treatment of refractory chronic cough (RCC) patients.

RCC refers to the persistence of cough symptoms for more than 8 weeks when the underlying disease that triggers cough has been optimally treated or the cause cannot be identified. Current research suggests that excessive coughing caused by Cough Hypersensitivity Syndrome (reacting to relatively harmless stimuli) is the main pathological mechanism of RCC.

It is estimated that there are approximately 28 million patients with chronic cough worldwide, of which 10 million patients have suffered from RCC for up to a year. Patients plagued by RCC may experience depression (53%), urinary incontinence (~50%), pain, rib fractures, social avoidance, and sleep deprivation. Gefapixant (Merck/Roche) is currently the only approved drug for treating RCC, though it is only available in Japan.

Studies show that P2X3 increases the excitability of airway sensory nerve fibers, thereby triggering cough hypersensitivity syndrome. Results from the Phase IIb SOOTHE study indicate that by selectively inhibiting the P2X3 receptor, camlipixant (50mg and 200mg, twice daily) can significantly reduce the daily cough frequency in RCC patients. Additionally, the incidence of taste disturbances (≤6.5%) was relatively low, a common adverse event associated with P2X2/P2X3 receptor-targeting drugs.

Based on these data, Bellus has initiated two registrational Phase III clinical trials (CALM-1 and CALM-2) for camlipixant, with results expected to be announced in H2 2024 and 2025, respectively. In addition, Bellus has also developed an oral once-daily formulation of camlipixant, which is currently in Phase I research.

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