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Eisai (4523) investor relations material
Eisai Status Update summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Scientific and clinical background
E2086 is a selective orexin receptor 2 agonist developed to address orexin deficiency, the underlying cause of narcolepsy type 1 (NT1), by promoting wakefulness and mitigating cataplexy symptoms in preclinical models.
The compound was discovered through high-throughput screening and features a complex, unique chemical structure, with significant improvements in activity achieved through medicinal chemistry and AI-based screening.
E2086 is positioned as a once-daily therapy, leveraging expertise in both orexin antagonists and agonists, aiming for broad application in sleep disorders.
Preclinical studies showed E2086 has strong efficacy and safety in non-clinical models.
Narcolepsy type 1 is characterized by orexin deficiency, leading to high disease burden and unmet medical needs.
Phase 1b clinical trial design and methodology
The Phase 1b trial was a multicenter, randomized, double-blind, five-period crossover study in adults with NT1, comparing three doses of E2086 (5, 10, 25 mg), placebo, and modafinil.
Each participant received all treatments in a randomized sequence, with washout periods between doses, and efficacy was assessed using the Maintenance of Wakefulness Test (MWT) and Karolinska Sleepiness Scale (KSS).
21 participants (mean age 35.6 years, 42.9% female) were included in the safety analysis; 19 completed all treatments.
Efficacy results
E2086 at all tested doses significantly extended sleep latency compared to placebo, with 10 and 25 mg doses outperforming modafinil in maintaining wakefulness up to seven hours post-dose.
Subjective sleepiness scores (KSS) also improved significantly with E2086, especially at 10 and 25 mg, which showed greater efficacy than modafinil.
E2086 10 mg and 25 mg sustained wakefulness for at least 30 minutes in each MWT trial.
All doses of E2086 resulted in statistically significant longer sleep latencies versus placebo (P < 0.0001) and modafinil.
At higher doses, patients achieved or exceeded normal wakefulness levels seen in healthy subjects, with sustained effects observed throughout the day.
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