0845 Samelisant (SUVN-G3031) Alleviates Excessive Daytime Sleepiness in Narcolepsy: Results from a Phase-2 Study
Bibliographic record
Abstract
Abstract Introduction Narcolepsy is a chronic sleep disorder characterized by excessive daytime sleepiness (EDS), uncontrollable sleep attacks, cataplexy, hypnagogic hallucinations, and sleep paralysis. Current treatments for narcolepsy often come with significant limitations, such as side effects, limited efficacy, or the necessity of combining multiple therapies. Samelisant is a selective inverse agonist of histamine 3 receptors, showing promising potential as a novel treatment for this condition. In preclinical studies involving orexin knockout mice, Samelisant demonstrated wake-promoting effects and reduced cataplexy, underscoring its therapeutic potential. Samelisant safety/tolerability has been established in healthy subjects. Methods Samelisant was evaluated as monotherapy in a Phase 2 proof-of-concept study conducted in the USA and Canada to treat EDS in patients with narcolepsy (NCT04072380). The study enrolled narcoleptic patients aged 18 to 65 years per ICSD-3 criteria, who had an Epworth Sleepiness Scale (ESS) score of ≥12 and a mean Maintenance of Wakefulness Test (MWT) time of < 12 minutes. A total of 190 patients were randomized into three treatment groups (placebo, Samelisant 2 mg, and Samelisant 4 mg) in a 1:1:1 ratio and received either placebo or Samelisant once daily for 14 days. The primary efficacy endpoint was the change in ESS score from Baseline to Day 14. Secondary and exploratory endpoints included changes in Clinical Global Impression – Severity, MWT and Patient Global Impression – Change scores from Baseline to Day 14. Safety was monitored throughout the study by the medical monitor and the data safety monitoring committee. Results Study evaluating Samelisant achieved primary efficacy endpoint demonstrating statistically significant (p< 0.024) and clinically meaningful reduction (-2.1 point) in ESS total score compared to placebo. Treatment with Samelisant resulted in significant improvement in EDS on scales assessed by both clinicians and patients. Samelisant was generally safe and well tolerated in narcolepsy patients and there were no serious events or death reported. Conclusion Samelisant holds promise as a monotherapy for treatment of EDS in narcolepsy, and a global Phase 3 study for the treatment of narcolepsy will be initiated in Q2 2025 Support (if any)
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".