A recent trial showed that nightly 30mg doses of zuranolone, a new drug to treat major depressive disorder (MDD), are safe and only requires about two courses to achieve clinical improvement.
Zuranolone is one of a new class of neuroactive steroid drugs that positively modulates GABAA receptors. It has high bioavailability, can be taken orally and has a half-life suitable for daily administration.
The SHORELINE Study is a Phase III, open-label, one year longitudinal study to evaluate the safety, tolerability, and need for repeat dosing with zuranolone in adults with MDD. Two cohorts with either zuranolone 30mg or 50mg as a starting dose taken once nightly for 14 days. Need for repeated dosing is assessed every 14 days based on a patient-reported assessment, with a maximum of five courses over a year.
Analysis of the data showed that the study’s primary endpoint of safety and tolerability show that zuranolone was generally well-tolerated in both dosage cohorts, with adverse events being generally consistent with those seen in previous zuranolone trials.
Secondary endpoints included response and remission as evaluated by the 17-item Hamilton Rating Scale for Depression (HAMD-17) and the number of times a patient received retreatment. A mean of 2.2 treatments resulted in patients with a clinical response (baseline HAMD-17 reduction of ≥50%) to the initial course of zuranolone 30mg. Additional data from patients in the 50 mg dose cohort is expected to be reported in late 2021.
“Sage embarked on the LANDSCAPE clinical program to evaluate the safety and efficacy of zuranolone with the ambition of reimagining the treatment for depression with the goal of a rapid-acting, durable, treat-as-needed option in a disease where innovation is lacking and the incidence rate has unfortunately increased exponentially in the last 20 years,” said Barry Greene, Chief Executive Officer at Sage Therapeutics. “Today we are announcing additional positive data from the SHORELINE Study that demonstrate continued strong results from the 30 mg dose and strengthens our confidence in the potential of the 50 mg dose. Designed as a naturalistic study, these data approximate real-world evidence of use of zuranolone at 30 mg and 50 mg doses. We look forward to the results of the WATERFALL and CORAL Phase 3 pivotal data readouts in MDD this year.”
Source: Sage Therapeutics
