Xenon Pharmaceuticals presents data from Phase 2 X-Nova trial

Xenon Pharmaceuticals announced data presentations highlighting azetukalner, XEN1101, clinical data in major depressive disorder, MDD, at the American Society of Clinical Psychopharmacology, ASCP, 2024 Annual Meeting in Miami, FL. Summary of Efficacy Data: The primary endpoint of the study was a change in the Montgomery-Asberg Depression Rating Scale, or MADRS, at week 6. The mean reduction was 13.90 in the placebo group, 15.61 in the 10 mg group and 16.94 in the 20 mg group. A clear dose response and a clinically meaningful, but not statistically significant. At week 1, the mean reduction in MADRS score from baseline was significantly different between placebo and azetukalner 20 mg groups, demonstrating early onset of efficacy. The mean reduction in the Hamilton Depression Rating Scale, or HAM-D17, score from baseline to week 6 was significantly different between placebo and azetukalner 20 mg groups. The mean reduction in the Snaith-Hamilton Pleasure Scale, or SHAPS, score from baseline to week 6 was significantly different between placebo and azetukalner 20 mg groups. There were no statistically significant differences in change from baseline BAI total scores to week 6 between placebo and azetukalner groups. Statistical significance was achieved in reporting of at least minimally improved symptoms of depression as assessed by physicians using the Clinical Global Impression of Improvement in the azetukalner 20 mg group compared to placebo. Summary of Safety and Tolerability Data: Azetukalner was well tolerated with a low incidence of treatment-emergent adverse events, and no serious TEAEs were reported in either dose group.