Marinus Pharmaceuticals announces data from Phase 2 Amaryllis study
The Amaryllis Study enrolled patients with a baseline HAM-D17 score of 25.5 for the low dose group and 25.4 for the high dose group. In this open-label dose-optimization study, 25 patients received 675 mg of oral ganaxolone at dinner for 28 days and 43 patients received 675 mg of oral ganaxolone at dinner and bedtime for two days, followed by a dinner time dose of 1125 mg once daily for the remainder of the 28-day treatment regimen. The low dose showed a mean HAM-D17 reduction from baseline of 0.8, 9.8, and 12.2 at 24 hours of treatment at 14 and 28 days of treatment, respectively, and the high dose showed a mean HAM-D17 reduction of 2.7, 9.3 and 14.5 at 24 hours of treatment at 14 and 28 days of treatment, respectively. The high dose showed a HAMD-17 reduction at 24 hours of treatment that was 2.0 points greater than the low dose, which was generally sustained over the treatment regimen, suggesting an efficacy trend with early activity onset. Oral ganaxolone was generally safe and well-tolerated with no serious adverse events reported and no discontinuations due to treatment related adverse events. Data from the Amaryllis Study support continued use of the once daily 1125 mg oral dose in future clinical studies. The Company will continue to engage strategic interest in oral ganaxolone and believes that the Amaryllis data would potentially be the basis of a constructive partnership.