GSK's Chronic Cough Drug Camlipixant Halted
GSK Halts Camlipixant Development for Chronic Cough After Mixed Phase III Efficacy Results
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Key Points
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RCC is described as a complex and under-recognised disease with limited treatment options.
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The phase IIb BALANCE trial will continue to evaluate camlipixant in IBS-D and IBS-M (NCT07519395).
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Analysts’ sentiment around the update is negative, with a Sell rating on GSK and a £19 price target.
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GSK’s stock fell about 3% in response to the CAML-1/CALM-2 update.
GSK has halted all development of camlipixant for refractory chronic cough (RCC), citing "limited efficacy" after two late-stage trials produced mixed and ultimately disappointing results, according to MarketScreener. The decision sent GSK shares down roughly 3-4% on the day of the announcement.
Refractory chronic cough is a condition where patients cough persistently and no clear cause can be found. It affects millions of people and has very few treatment options. GSK's camlipixant was seen as a promising candidate — making this setback a significant blow to the company's respiratory pipeline.
Two Phase III Trials Deliver a Letdown for GSK
The CALM-1 trial showed a meaningful reduction in 24-hour cough frequency at 12 weeks for the 50mg twice-daily dose of camlipixant. That looked promising at first. But the CALM-2 trial, which ran longer at 24 weeks, failed to hit the same primary endpoint, according to MarketScreener. The 25mg dose failed in both studies.
Key secondary endpoints were not met in either trial. Adverse events were similar to placebo across both studies. GSK concluded that the aggregate data showed the drug is "unlikely to transform patient care," according to Benzinga. On that basis, the company decided to stop all further development of camlipixant in RCC.
Stock Falls as Analysts Warn of Deeper Trouble
GSK shares dropped about 3-4% after the announcement, reflecting investor disappointment, according to Tri-City Herald. The camlipixant program had been closely watched as part of GSK's broader effort to build out its respiratory and specialty medicines portfolio.
Analyst sentiment turned negative following the update. At least one firm holds a Sell rating on GSK stock with a price target of £19. The failed trials remove a near-term growth driver that the market had been pricing in, adding pressure to a company already navigating a busy pipeline.
IBS Trial Continues as GSK Keeps One Door Open
Not all is lost for camlipixant. GSK will continue its phase IIb BALANCE trial, which is testing the drug in irritable bowel syndrome with diarrhea (IBS-D) and mixed IBS (IBS-M), according to MarketScreener. The trial is registered under NCT07519395. This means camlipixant stays in GSK's portfolio — just in a very different disease area.
Camlipixant works by blocking a receptor called P2X3, which plays a role in nerve signaling. That same mechanism may be relevant in the gut, giving GSK a scientific reason to press on with the IBS program. Results from the chronic cough trials will be submitted for future presentation or publication.
RCC Patients Left With Few Options After Program Ends
Refractory chronic cough is widely described as a complex and under-recognised disease. Patients often cough hundreds of times per day with no effective remedy. The condition has a major impact on quality of life. GSK's exit narrows an already thin field of drugs in late-stage development for this indication, according to Tri-City Herald.
GSK's P2X3 program in RCC now effectively ends with camlipixant. Rival programs from other companies will be watched closely as the only remaining hope for patients with this difficult-to-treat condition. For GSK, the focus shifts to other parts of its pipeline, with camlipixant's future tied entirely to the gut.
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