Supernus Presents Promising Data from Open-Label Phase 2a Study of SPN-820 Data in Major Depressive Disorder at Psych Congress 2024

Core Insights - Supernus Pharmaceuticals presented new data on SPN-820, a novel treatment for major depressive disorder (MDD), at Psych Congress 2024, highlighting its rapid onset and favorable safety profile [1][5][6] Study Results - The Phase 2a study involved 40 subjects with MDD, assessing the efficacy and safety of SPN-820 administered at 2400 mg every three days [7] - Participants showed significant reductions in depressive symptoms, with a decrease of 80% in suicidal ideation from 12.5% at baseline to 2.6% by Day 10 [4] - The Hamilton Depression Rating Scale-6 items (HAM-D6) showed improvements of -6.1 at two hours and -9.6 at Day 10, while the Montgomery Åsberg Depression Rating Scale (MADRS) indicated improvements of -16.6 at four hours and -22.9 at Day 10 [2] Efficacy and Tolerability - Rapid response rates were observed, with 50% of participants achieving a ≥50% reduction in MADRS scores at four hours, increasing to 84.2% by Day 10 [3] - The tolerability profile was favorable, with a low discontinuation rate of 2.5% due to adverse events, which were mostly mild to moderate [4][5] Mechanism of Action - SPN-820 is a first-in-class, orally active small molecule that modulates the mTORC1 pathway, enhancing synaptic function and cellular metabolism in the brain [6] - The compound is designed to provide rapid antidepressant effects without dissociative side effects, with ongoing Phase 2b studies involving approximately 227 patients with treatment-resistant depression [6]