(RTTNews) - GSK plc (GSK), a biopharmaceutical company, on Friday announced the discontinuation of Phase 3 development for Camlipixant in treating refractory chronic cough (RCC).
Camlipixant is a P2X3 receptor antagonist that was being evaluated as a potential anti-inflammatory therapy to treat chronic cough. The drug targets the P2X3 receptor to reduce the severity of coughing, known as the antitussive effect.
The assessment was carried out through two Phase 3 trials - CALM-1 and CALM-2 - which dosed adult patients twice to determine safety and efficacy of camlipixant versus a placebo.
The CALM-1 trial met its primary endpoint as patients showed a significant reduction in 24-hour cough frequency by week 12. CALM-2, however, did not achieve this objective by week 24. The key secondary endpoint of a Chronic Cough Diary (CCD) measure did not meet target thresholds in either study.
Furthermore, the overall incidence and severity of treatment-related adverse events were similar in patients receiving either camlipixant or placebo.
The company inferred from these results that camlipixant would not provide the assumed transformative care for RCC, and discontinuation of the trial was the most viable measure.
Data from the Phase 3 CALM program will be published to support future scientific research into chronic cough.
The company will be moving forward in evaluating Camlipixant in treating irritable bowel syndrome-diarrhoea (IBS-D) and irritable bowel syndrome-mixed (IBS-M) via the Phase 2b BALANCE study.
GSK closed Thursday at $52.77, up 2.57%. In the pre-market, shares are trading at $50.59, down 4.12%.
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