Supernus Shares Promising Phase 2a SPN-820 Data in Major Depression at Psych Congress 2024

Supernus Pharmaceuticals, Inc., a biopharmaceutical firm dedicated to advancing and marketing products for central nervous system (CNS) diseases, recently presented findings from its exploratory open-label Phase 2a study of SPN-820 at the Psych Congress 2024. Designed for adults with major depressive disorder (MDD), the study aimed to evaluate the safety and efficacy of SPN-820, a novel intracellular modulator of mTORC1. This treatment was administered as an adjunct to baseline antidepressant therapy, with dosages of 2400 mg every three days.

Incorporating 40 subjects, 38 of whom completed the 10-day treatment period, the study found significant and rapid decreases in depressive symptoms. Specifically, SPN-820 led to a reduction of -6.1 on the Hamilton Depression Rating Scale-6 items (HAM-D6) within two hours, which further improved to -9.6 by Day 10. On the Montgomery Åsberg Depression Rating Scale (MADRS), the improvements were more pronounced, with scores decreasing by -16.6 at four hours and -22.9 by Day 10.

The new data highlighted a substantial response and remission rate, with 50.0% of participants achieving a MADRS response (≥50% reduction) and 35.0% reaching remission (MADRS ≤10) by the four-hour mark. By Day 10, these figures improved to 84.2% and 63.2%, respectively. Furthermore, suicidal ideation saw a dramatic reduction of 80%, dropping from 12.5% at baseline to just 2.6% by Day 10.

Importantly, SPN-820 was generally well-tolerated. Adverse events (AEs) were infrequent and mainly mild to moderate, including headaches, nausea, somnolence, and dizziness. Other mild to moderate AEs observed were cognitive disorder, dry mouth, fatigue, nasal decongestion, and oral paresthesia. The study reported no severe or serious adverse events, and the discontinuation rate due to AEs was low at 2.5%.

Dr. Jonathan Rubin, Chief Medical Officer and Senior Vice President of Research & Development at Supernus Pharmaceuticals, expressed optimism about SPN-820's potential, citing its rapid antidepressant effects, good tolerability, and convenient oral administration. Dr. Rubin emphasized that the drug could offer a new treatment option for depression, providing quick and effective symptom relief without significant side effects.

SPN-820 is an orally active small molecule that modulates the brain's mechanistic target of rapamycin complex 1 (mTORC1), enhancing synaptic function through an intracellular mechanism. The drug is being developed to provide a rapid-onset antidepressant response, demonstrating significant efficacy without dissociative side effects in early clinical trials. A Phase 2b clinical study is currently underway, involving approximately 227 adult patients with treatment-resistant depression.

Supernus Pharmaceuticals specializes in CNS diseases, with a portfolio that includes approved treatments for epilepsy, migraine, ADHD, and various conditions related to Parkinson's disease. The company continues to innovate, developing new CNS therapies to address unmet medical needs.