Aculys touts positive Phase III data for pitolisant for narcolepsy

Japanese clinical-stage biotech Aculys Pharma announced that pitolisant (BF2.649), a histamine H3 receptor antagonist/inverse agonist, has achieved its primary endpoint in a Phase III clinical trial targeting Japanese patients with narcolepsy.

In this trial, pitolisant was administered orally to narcolepsy patients for eight weeks. The trial demonstrated the drug’s effectiveness regarding its primary endpoint, which was improvement in excessive daytime sleepiness compared to a placebo group using the Epworth Sleepiness Scale (ESS). Statistically significant difference in ESS was observed between the two groups.

Furthermore, the secondary endpoint regarding the frequency of cataplexy attacks showed a suppression effect comparable to that observed in overseas trials. No serious adverse effects were noted, and the safety and tolerability results were consistent with those from clinical trials conducted abroad.