Camlipixant

GSK's hopes of delivering a second major pipeline win of the year petered out on Friday following disappointing findings from a pair of Phase III trials for camlipixant in chronic cough. Given the results, the company has abandoned plans to continue development of the P2X3 receptor antagonist in refractory chronic cough.The drugmaker said that while the 50-mg twice-daily dose of camlipixant in adults with refractory chronic cough met the primary endpoint of the CALM-1 study — showing a statistically significant reduction in 24-hour cough frequency versus placebo at week 12 — it failed to meet the same goal in the CALM-2 trial at week 24. In addition, camlipixant dosed at 25 mg twice daily did not reach statistical significance in either study.GSK added that key secondary endpoints, including a Chronic Cough Diary (CCD) measure, also failed to meet target thresholds in the two trials. Meanwhile, across the pair of studies, the company noted that the overall incidence and severity of treatment-related adverse events were similar in patients receiving either camlipixant or placebo."Based on the aggregate data, the limited efficacy demonstrated is unlikely to transform patient care," GSK said. IBS study continuesThe company indicated that the Phase IIb BALANCE trial investigating camlipixant in adults with irritable bowel syndrome - diarrhoea (IBS-D) and irritable bowel syndrome - mixed (IBS-M) will continue. GSK obtained the drug via its $2-billion purchase of Bellus Health in 2023.The setback for camlipixant comes shortly after new CEO Luke Miels said GSK had completed a review of its 50 most promising programmes as it looks to accelerate its R&D efforts. At the time, Miels remarked: "When we see them, we'll move resources where there is success or we'll rapidly redeploy it where there's not. That's how we're going to run the business. And you'll hear more from us."GSK was hoping that camlipixant would give its pipeline a similar boost to that delivered by the chronic hepatitis B therapy bepirovirsen in May. Results from the B-Well 1 and B-Well 2 studies showed that the therapy was associated with a near one-in-five functional cure response rate across the two trials.For related analysis, see — Spotlight On: GSK delivers historic win for hepatitis B patients and KOL Views Q&A: GSK's bepirovirsen is one small step for HBV patients, one giant leap for HBV therapy.

Dive Brief:GSK is discontinuing trials of an experimental chronic cough medicine it bought in a $2 billion deal three years ago, announcing Friday that camlipixant had failed to meet nearly all of the goals in two Phase 3 trials. The British pharmaceutical giant said the limited efficacy demonstrated is unlikely to transform patient care.The termination closes a blockbuster opportunity for GSK, which hoped to add camlipixant to a portfolio of respiratory drugs that includes asthma and COPD treatments like Trelegy and Anoro. The company said it is continuing Phase 2 trials in people with irritable bowel syndrome.Camlipixants failure follows that of two others in the P2X3 antagonist class that were developed by Bayer and Merck & Co, the latter of which spent more than $500 million to gain control of its drug. The setback also clears away a threat to Trevi Therapeutics, which is advancing a different type of treatment in chronic cough.Dive Insight:GSK gained camlipixant when it acquired Bellus Health, three years after the drug initially failed in a Phase 2 trial. A second mid-stage study delivered stronger results, showing a statistically significant reduction in cough frequency.The lower, 50 milligram twice-daily dose in that successful study was the highest evaluated in late-stage testing. That dose worked in one of the two experiments, significantly reducing 24-hour cough frequency when compared to a placebo. Yet, in the second it failed. A lower, twice-daily 25 milligram dose also failed in both trials. And both studies missed key secondary goals, GSK said.The failure is disappointing, but isnt a material setback to the GSK equity story, wrote Jefferies analyst Michael Leuchten in a client note.Our investment thesis is increasingly centered on GSK's oncology portfolio, where recent acquisitions coupled with internal assets provide substantially larger and longer-duration value creation opportunities, Leuchten wrote.He added that while the Bellus acquisition was made under former CEO Emma Walmsley, we can't absolve the current management team from the failure, noting that current CEO Luke Miels and R&D chief Tony Wood would have been involved here.But whats a loss for GSK is a gain for Trevi, shares of which rose as much as 16% in morning trading Friday. Leerink Partners analyst Roanna Ruiz wrote that the camlipixant failure creates an open field opportunity for Haduvio, an opioid Trevi has repurposed from pain relief for use in chronic cough.Trevi is readying a Phase 3 trial of Haduvio in people with chronic cough related to idiopathic pulmonary fibrosis and a Phase 2 trial in the refractory chronic cough setting where camlipixant failed. '