GSK Halts Cough Drug Camlipixant After Late-Stage Trial Failure
London: GSK will halt development of an experimental drug to treat refractory chronic cough after it failed to meet key goals across two late-stage trials, sending the British drugmaker's shares down about 4% on Friday.
The higher 50 mg dose of camlipixant reduced daily coughing over 12 weeks in one trial but failed to replicate that result in a second study over 24 weeks, data showed.
The trial failure could raise questions for investors who are not fully convinced that the company can reach its target of £40 billion ($53.76 billion) in annual revenue by 2031.
GSK, which stands by its long-term target, had forecast peak annual sales of about £2.5 billion for camlipixant, although analyst estimates were closer to £1 billion.
"The camlipixant development program was seen as having an above average risk of failing, as chronic cough is a difficult-to-treat disease," said Markus Manns, portfolio manager at GSK shareholder Union Investment, adding that it could increase pressure for further acquisitions.
CEO Luke Miels, who succeeded Emma Walmsley in January, is under pressure to convince investors GSK can meet the target while managing looming patent expiries for blockbuster HIV drug dolutegravir.
LONG-TERM SALES TARGET
JPMorgan analysts said GSK had positioned camlipixant as one way to help close the gap between analysts' forecasts of roughly £35 billion in 2031 sales and the company's £40 billion target.
But some saw the clinical failure as manageable.
"Getting this through would have been a nice to have but not a must-have for the top-line trajectory," Jefferies analyst Michael Leuchten said.
Leuchten said that recent acquisitions could help the company's sales growth trajectory and are not yet reflected in market expectations. Last month, GSK spent a record $10.6 billion to acquire U.S. cancer focused drug developer Nuvalent .
'UNLIKELY TO TRANSFORM PATIENT CARE'
The drug's lower 25 milligram dose did not provide a clear benefit in either study. Neither of the two doses met key secondary goals, including patient-reported outcomes from a Chronic Cough Diary.
GSK said that the limited benefit shows the drug was "unlikely to transform patient care."
GSK will continue testing camlipixant as a treatment for irritable bowel syndrome. It also plans to share the data to contribute to the scientific understanding of refractory chronic cough, a condition for which limited treatment options exist.
Nearly 10 million patients suffer from the condition globally every year, which can cause people to cough more than 900 times a day.
GSK had bought the drug in a $2 billion acquisition of Bellus Health in 2023.
