Sage Therapeutics’ (NSDQ:SAGE) and Biogen’s (NSDQ:BIIB) experimental depression drug zuranolone fared well in a Phase 3 clinical trial comparing it to placebo in the treatment of postpartum depression.
The investigational drug demonstrated meaningful improvements in terms of the baseline 17-item Hamilton Rating Scale for Depression (HAMD-17) score, the most common clinician-administered depression assessment scoring system.
After a 15-day treatment period, the zuranolone group had a mean change in HAM-D score of −17.8, resulting in a final mean score of 11.0, which is the normal range. Meanwhile, the −13.6 change in the placebo group results in a final mean score of 14.8, indicating mild-to-moderate depression.
For context, in the HAM-D system, a score of 10–13 indicates mild depression. The range of 14–17 represents mild to moderate depression. A score higher than 17 indicates severe depression.
The baseline mean HAM-D score for the 76 randomized placebo recipients was 28.4. The mean for the 77 zuranolone recipients was 28.8.
Sage and Biogen are also testing zuranolone for major depressive disorder.
Earlier this month, the companies announced that the drug also led to a statistically significant and clinically meaningful reduction in people with depression. That study also used HAMD-17 scores to measure improvement in depression symptoms. Clinical investigators noticed cumulative treatment effects after three, eight and 12 days, respectively.
Four weeks after the end of dosing, patients retained an average of 86% of their HAMD-17 improvement.
Zuranolone also appears to be generally well-tolerated. In the latter trial, the trial completion rate was 90.3% for those taking the experimental therapy.
Last year, Biogen entered into a $1.5 billion licensing agreement with Sage Therapeutics to commercialize zuranolone (SAGE-217) and another investigational drug known as SAGE-324 for essential tremor.
Filed Under: clinical trials, Drug Discovery, Psychiatric/psychotropic drugs