Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SPN-817
SPN-817, Treatment B · 4 trials · 4 indications
The percent of participants who took at least one dose of SPN-817 and reported at least one adverse event during the 1-year SPN-817 Treatment Period
Percent change in 28-day frequency of focal seizures during the 14 week Maintenance Period relative to baseline
The incidence of adverse events.
Area under the curve (AUC)
| Arm | Type | Description |
|---|---|---|
| SPN-817 | EXPERIMENTAL | SPN-817, bid |
| Placebo | PLACEBO_COMPARATOR | Placebo, bid |
| Open-Label Treatment | EXPERIMENTAL | 0.25 mg to 4 mg SPN-817 taken orally twice daily |
| Cohort 1 | ACTIVE_COMPARATOR | BIS-001: Treatment A and SPN-817: Treatment B |
| Cohort 2 | ACTIVE_COMPARATOR | BIS-001: Treatment A and SPN-817: Treatment C |
| Name | Type | Description |
|---|---|---|
| SPN-817 | DRUG | SPN-817 starting at 0.25 mg bid up to 4.00 mg bid |
| Placebo | DRUG | Placebo, bid |
| SPN-817, Treatment B | DRUG | SPN-817 Treatment B, is an Extended Release formulation of Huperzine A, an acetylcholinesterase inhibitor |
| SPN-817, Treatment C | DRUG | SPN-817 Treatment C, is an Extended Release formulation of Huperzine A, an acetylcholinesterase inhibitor |
| BIS-001, Treatment A | DRUG | BIS-001 is an Extended Release formulation of Huperzine A, an acetylcholinesterase inhibitor |
Inclusion Criteria: 1. Completed antecedent SPN-817 double-blind study 2. Taking a stable dosage regimen (maintained during the antecedent study) of at least one antiseizure medication (ASM) and no more than 4 ASMs Exclusion Criteria: 1. Has current nonepileptic events that could be confused by t...
Top 9 of 13 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Xenon Pharmaceuticals Inc. | XENE | 4 | PHASE3 | Azetukalner |
| Praxis Precision Medicines, Inc. | PRAX | 5 | PHASE3 | Vormatrigine, Elsunersen |
| Rapport Therapeutics, Inc. | RAPP | 3 | PHASE3 | RAP-219 |
| Supernus Pharmaceuticals, Inc. | SUPN | 4 | PHASE2 | SPN-817, Treatment B, BIS-001ER |
| Biohaven Ltd. | BHVN | 3 | PHASE2 | BHV-7000 |
| Harmony Biosciences Holdings, Inc. | HRMY | 1 | PHASE3 | Clemizole |
| Jazz Pharmaceuticals Public Limited Company | JAZZ | 3 | PHASE1 | CBD-OS, Epidiolex |
| Bright Minds Biosciences Inc. | DRUG | 1 | PHASE2 | BMB-101 |
| uniQure N.V. | QURE | 1 | PHASE1 | AMT-260 |
SPN-817 is an investigational small molecule being developed for epilepsy, including focal onset seizures and treatment-resistant epilepsy. It is currently in Phase 2 clinical development and is not yet approved by the FDA. The drug is being studied in adult patients with these seizure disorders.
SPN-817 targets acetylcholinesterase (AChE), an enzyme involved in neurotransmission. By inhibiting this enzyme, the drug may modulate cholinergic signaling in the brain, which is being investigated as a potential mechanism for reducing seizure activity in epilepsy patients.
SPN-817 is being developed by Supernus Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SUPN. The company is conducting Phase 2 clinical trials to evaluate the drug's safety and efficacy in treating epilepsy and focal onset seizures.
SPN-817 is currently in Phase 2 clinical development. It is being evaluated in multiple Phase 2 trials, including a double-blind, placebo-controlled study in adults with focal onset seizures and an open-label extension study. The drug is investigational and has not received FDA approval.
SPN-817 is being studied in several clinical trials. NCT05518578 is a Phase 2 safety and tolerability study in adults with treatment-resistant epilepsy. NCT06798896 is a Phase 2 double-blind, placebo-controlled study in focal onset seizures. NCT07141329 is an open-label extension study in focal onset seizures. A Phase 1 bioavailability study (NCT05102552) has been completed.
SPN-817 is a distinct investigational compound with a unique mechanism of action targeting acetylcholinesterase. It is not the same as other marketed epilepsy drugs, which typically work through different pathways such as sodium channels or GABA receptors. SPN-817 is being developed specifically for treatment-resistant epilepsy and focal onset seizures.