GSK (NYSE: GSK) halts camlipixant cough drug after Phase III data
Filing Impact
Filing Sentiment
Form Type
6-K
Rhea-AI Filing Summary
GSK plc reported mixed Phase III results for camlipixant in adults with refractory chronic cough. In the 52-week CALM-1 study, camlipixant 50mg twice daily achieved the primary endpoint, showing statistically significant reductions in 24-hour cough frequency versus placebo at week 12.
In the 24-week CALM-2 study, the same 50mg dose did not reach statistical significance at week 24, and the 25mg twice-daily dose was not significant in either trial. Key secondary endpoints, including the Chronic Cough Diary measure, were not met. With overall safety similar to placebo but efficacy deemed unlikely to transform patient care, GSK will not progress camlipixant further in RCC, while continuing the Phase IIb BALANCE trial in irritable bowel syndrome.
Positive
- None.
Negative
- GSK will no longer develop camlipixant for refractory chronic cough after Phase III data showed limited efficacy "unlikely to transform patient care," removing this indication from its late-stage pipeline.
Key Figures
CALM-1 duration: 52-week study
CALM-2 duration: 24-week study
Camlipixant high dose: 50mg twice daily
+3 more
6 metrics
CALM-1 duration
52-week study
Design of the CALM-1 Phase III trial in adults with refractory chronic cough
CALM-2 duration
24-week study
Design of the CALM-2 Phase III trial in adults with refractory chronic cough
Camlipixant high dose
50mg twice daily
Dose that met the primary endpoint in CALM-1 at week 12
Camlipixant low dose
25mg twice daily
Dose that did not reach statistical significance in either CALM study
CALM-1 primary endpoint timing
week 12
Time point for assessing 24-hour cough frequency versus placebo in CALM-1
CALM-2 primary endpoint timing
week 24
Time point for assessing 24-hour cough frequency versus placebo in CALM-2
Key Terms
refractory chronic cough, P2X3 receptor antagonist, treatment-related adverse events, phase IIb, +1 more
5 terms
refractory chronic cough medical
"adults with <b>refractory chronic cough</b> (RCC)"
A refractory chronic cough is a long-lasting cough that persists despite standard medical evaluation and treatment, typically lasting eight weeks or more and not improving with usual therapies. Investors should care because it represents a clear unmet medical need that can drive demand for new drugs, devices, or diagnostics—similar to a stubborn problem customers keep returning to a store for until a better solution appears—affecting market potential and regulatory attention.
P2X3 receptor antagonist medical
"camlipixant (a <b>P2X3 receptor antagonist</b>) in adults"
phase IIb medical
"The <b>phase IIb</b> BALANCE trial will continue"
Phase IIb is a mid-stage clinical trial that tests whether an experimental treatment works and what dose is best by studying it in a larger group of patients than early tests. For investors, Phase IIb results are important because they substantially reduce uncertainty about a drug’s effectiveness and safety, and positive or negative outcomes often drive company valuation, partnership interest, and the likelihood of advancing to the large, costly Phase III trials.
inside information regulatory
"This announcement contains <b>inside information</b>."
Information not available to the public that, if known, would likely cause a company’s stock or bonds to rise or fall—for example, undisclosed earnings, deals, product results, or management plans. It matters because trading on that information gives an unfair advantage, can distort market prices, and is typically illegal or subject to strict rules, so investors watch for proper disclosure and compliance to protect fair, transparent markets.
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What did GSK (GSK) report about the CALM-1 Phase III trial?
GSK reported that CALM-1 met its primary endpoint, with camlipixant 50mg twice daily producing statistically significant reductions in 24-hour cough frequency versus placebo at week 12 in adults with refractory chronic cough.
How did CALM-2 results differ from CALM-1 for GSK (GSK)?
In CALM-2, camlipixant 50mg twice daily did not achieve statistical significance on the same primary endpoint at week 24, and the 25mg twice-daily dose was not significant in either CALM-1 or CALM-2, unlike the CALM-1 high-dose result.
Why did GSK (GSK) halt camlipixant development in refractory chronic cough?
GSK decided not to progress camlipixant in refractory chronic cough because the aggregate Phase III data showed limited efficacy that the company stated is "unlikely to transform patient care," despite generally similar safety to placebo across both trials.
What safety profile did GSK (GSK) observe for camlipixant in the CALM trials?
Across CALM-1 and CALM-2, GSK stated that the overall incidence and severity of treatment-related adverse events were similar between patients receiving camlipixant and those receiving placebo, indicating a broadly comparable safety profile in these Phase III studies.
Is GSK (GSK) continuing to develop camlipixant for any other indications?
Yes. While RCC development is stopping, the Phase IIb BALANCE trial will continue to evaluate camlipixant’s efficacy and safety in adults with irritable bowel syndrome – diarrhoea (IBS-D) and irritable bowel syndrome – mixed (IBS-M).
What disease area were GSK (GSK) CALM-1 and CALM-2 targeting?
CALM-1 and CALM-2 targeted adults with refractory chronic cough (RCC), described as a complex and under-recognised disease with limited treatment options, assessing camlipixant, a P2X3 receptor antagonist, for efficacy and safety.