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

Supernus Pharmaceuticals, Inc.
Supernus Pharmaceuticals, Inc.

In This Article:

Participants in the Phase 2a study experienced rapid and meaningful decreases in depressive symptoms

Suicidal ideation decreased by 80%

SPN-820 was well-tolerated with few adverse events

SPN-820 is a novel, first-in-class intracellular modulator of mTORC1 for the treatment of depression

ROCKVILLE, Md., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced data in a poster presentation at Psych Congress 2024 with new data from its exploratory open-label Phase 2a clinical study of SPN-820 in adults with major depressive disorder (MDD). The study examined the safety and tolerability of 2400 mg of SPN-820 given once every three days as an adjunctive treatment to the current baseline antidepressant therapy and assessed the rapid onset of improvement in depressive symptoms. The study included 40 enrolled subjects, of which 38 completed the 10-day treatment period.

In the Phase 2a study, SPN-820 demonstrated a clinically meaningful improvement of -6.1 at two hours and -9.6 at Day 10 on the Hamilton Depression Rating Scale-6 items (HAM-D6), as well as a clinically meaningful improvement of -16.6 at four hours and -22.9 at Day 10 on the Montgomery ?sberg Depression Rating Scale (MADRS).

New data from the Phase 2a study presented at Psych Congress 2024 demonstrate a rapid MADRS response rate (≥50% reduction) and remission (MADRS 10), reaching 50.0% and 35.0% of participants, respectively, at 4 hours, with additional improvement to 84.2% and 63.2% by Day 10.

Suicidal ideation decreased by 80% (from 12.5% with suicidal ideation at baseline to 2.6% with suicidal ideation at Day 10). SPN-820 was well-tolerated with few adverse events (AEs) and had acceptable tolerability with a low discontinuation rate due to AEs (2.5%). Most common AEs related to the drug were mild to moderate and included headache, nausea, somnolence, and dizziness. Additional AEs such as cognitive disorder, dry mouth, fatigue, nasal decongestion, and paresthesia oral were observed and considered mild to moderate. There were no severe AEs and no serious AEs reported.

“The data shared at the Psych Congress suggest the promise of SPN-820 as a potential first-in-class, novel treatment option for patients with depression, in which it demonstrated rapid acting antidepressant properties, a favorable tolerability profile and convenient, oral at home administration,” said Jonathan Rubin, M.D., Chief Medical Officer and Senior Vice President, Research & Development, Supernus Pharmaceuticals. “By decreasing symptoms safely and effectively without certain burdensome side effects, with a majority of patients reaching a remission threshold in just 10 days, SPN-820 exhibited meaningful improvements on the main depression rating scales, and we remain very excited about its potential to make a difference in the lives of those suffering from depression.”