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GSK ends camlipixant research in RCC as trials show ‘limited efficacy’

ALN

GSK PLC on Friday said it will not progress its development of camlipixant for refractory chronic cough, after phase 3 study data suggested that it ‘is unlikely to transform patient care’.

The London-based pharmaceutical company said the decision was based on aggregated data from the Calm-1 and Calm-2 phase 3 trials, which were assessing the efficacy and safety of two doses of camlipixant in adults with RCC.

GSK said Calm-1 met its primary endpoint with a 50-milligram, twice-daily dose of camlipixant, showing statistically significant reductions compared with a placebo in 24-hour cough frequency at week 12.

However, Calm-2 did not reach statistical significance in the same endpoint, also with 50 mg twice daily, at week 24. Also, neither study showed camlipixant reaching statistical significance at a 25mg dose twice daily.

Camlipixant ‘did not meet target thresholds’ in either study for key secondary endpoints, including a chronic cough diary measure, GSK added.

‘Based on the aggregate data, the limited efficacy demonstrated is unlikely to transform patient care,’ GSK said.

As a result, it ‘has decided not to progress further development of camlipixant in RCC.’

However, GSK said the phase 2b Balance trial, which is evaluating the efficacy and safety of camlipixant in adults with ’mixed’ irritable bowel syndrome and IBS with diarrhoea, will continue.

Shares in GSK were down 3.5% at 1,887.50 pence on Friday morning in London.

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