Company: SUPN
Filing Date: 2025-02-25
Form Type: 10-K
Source: 0001356576-25-000017
Chunk: 604

Company: SUPERNUS PHARMACEUTICALS, INC.
Filing Date: 2025-02-25
Form: 10-K
Item: Item 1
Chunk 604
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 period (n=6). 

•Maintenance period:

◦56% median seizure reduction from baseline.

◦70% of subjects had 30% or more seizure reduction.

◦60% of subjects had 50% or more seizure reduction.

◦30% of subjects had 75% or more seizure reduction.

•Post-maintenance extension period:

◦66% median seizure reduction from baseline.

◦83% of subjects had 30% or more seizure reduction.

◦67% of subjects had 50% or more seizure reduction.

◦50% of subjects had 75% or more seizure reduction.

•Seizure Freedom:

◦Maintenance period: 1 out of 10 subjects (10%) who completed a post-baseline seizure diary had at least one four-week seizure free period.

◦Post-maintenance extension period: 1 out of 6 subjects (17%) had at least one four-week seizure free period.

Assessment by EpiTrack®, a validated cognitive screening tool designed for patients with epilepsy, indicated that 75% of 16 subjects was equally split between those who improved and those who had no change in cognitive function. SPN-817 was safe and had acceptable tolerability with 2 subjects discontinuing because of treatment related adverse events out of the 26 subjects who entered the maintenance period. The second part of this study (Stage B) is on-going and includes the use of a concomitant anti-emetic to reduce the cholinergic adverse events observed in the study. 

We initiated a Phase 2b randomized, double-blind, placebo-controlled study of 3mg and 4mg twice daily doses in approximately 258 adult patients with treatment resistant focal seizures.

SPN-820 (NV-5138) 

SPN-820 is a first-in-class, orally active small molecule that activates the brain mechanistic target of rapamycin complex 1 (mTORC1), a gatekeeper of cellular metabolism and renewal. SPN-820 binds to and modulates sestrin, which senses amino acid availability in the brain, a potent natural activator of mTORC1.

Depression is associated with synapse loss and reduced synaptic plasticity in key brain regions including the prefrontal cortex and increasing mTORC1-mediated synaptic plasticity is a promising avenue to treat depression and associated symptoms. SPN-820 selectively binds to intracellular sestrin proteins and subsequently engages a cascade of multi-protein complexes, enhancing mTORC1 signaling