Ahead of FDA filing, Sage and Biogen tout more data in hopes of alleviating durability concerns
With an FDA filing rolling for zuranolone, Sage and Biogen are bringing more data on how the drug works in an open-label study.
The partners reported that out of patients with major depressive disorder who responded to the first round of treatment, the median time to another episode requiring repeat treatment was 135 days for those who got 30 mg of zuranolone and 249 days for those who got 50 mg. The data come as questions about the durability of zuranolone followed its two randomized trial readouts.
Sage and Biogen are painting their drug as a potential acute treatment for depression episodes, unlike drugs currently used for chronic maintenance.
The two companies previously reported the responder rate of the second group in the open-label study — 80% of nearly 200 patients responded to the 50 mg treatment. But they released only the non-responder rate for the 30mg cohort of 725 patients. About 24% of patients did not respond to treatment in that cohort.
However, in the 30 mg cohort, only about 67% (489 of the 725) of the total participants continued in the study — leaving a chunk of patients who may have responded to treatment but did not continue in the study.
In March, Sage reported that of those 489 patients continuing in the 30 mg arm of the study, just over 40% used zuranolone only once. Another quarter used two courses, and around 12% used three courses. About 10% and 9% used four and five courses, respectively.
The open-label SHORELINE study is one of a package of studies that Sage and Biogen are bringing to the FDA in hopes of getting zuranolone approved for major depressive disorder. The duo is also gunning for a filing in postpartum depression in 2023, and posted a Phase III win for that indication in June.
Sage and Biogen previously reported two Phase III trials on zuranolone that met both their primary endpoints, though the readouts were clouded by concerns over the durability of the drug’s effects. In both trials, while differences in depression symptom scores were significant after the two-week treatment period, they were no longer statistically significant another 15 days later. (And in one of those trials, Sage changed the primary endpoint, perhaps in reaction to durability concerns.)