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.
- Camlipixant’s 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 isn’t “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 what’s 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.
