XENE - Xenon Pharmaceuticals Presents Data from Phase 2 X-NOVA Clinical Trial of Azetukalner in Major Depressive Disorder at the American Society of Clinical Psychopharmacology 2024 Annual Meeting | Benzinga
VANCOUVER, British Columbia, May 28, 2024 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a neuroscience-focused biopharmaceutical company, 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.
Mr. Ian Mortimer, Xenon's President and Chief Executive Officer, stated, "We are pleased to present these data from our Phase 2 proof-of-concept X-NOVA study of azetukalner in MDD at the ASCP meeting. The X-NOVA results demonstrated a clinically meaningful reduction in depression, in addition to an early onset of action, a significant reduction in anhedonia, and a potentially differentiated safety profile of azetukalner as compared to other antidepressants. These compelling data, along with azetukalner's novel mechanism of action, support the potential of azetukalner to have a differentiated profile in the treatment of depression."
Mr. Mortimer continued, "We are looking forward to connecting with ASCP attendees and continuing to raise awareness of azetukalner's potentially unique attributes and highlight our late-stage clinical work in MDD, starting with the initiation of our Phase 3 MDD program in the second half of this year."
Xenon's Presentations at ASCP:
Oral Presentation: "Efficacy and Safety of Azetukalner (XEN1101), a Novel, Kv7 Potassium Channel Opener in Adults With Moderate to Severe Major Depressive Disorder: Results From the Phase 2 Proof-of-Concept X-NOVA Study"
Presenter: Dr. Joe McIntosh, Senior Vice President, Clinical Development, Xenon Pharmaceuticals
May 28, 2024 at 2 pm ET in Salon 3
Poster: "Efficacy and Safety of Azetukalner (XEN1101), a Novel, Kv7 Potassium Channel Opener in Adults With Moderate to Severe Major Depressive Disorder: Results From the Phase 2, Proof-of-Concept X-NOVA Study"
May 29, 2024 at 11:15 am to 1 pm ET in Salon 4
The Company's presentations summarize clinical data from its topline results from the Phase 2 proof-of-concept X-NOVA clinical trial, which evaluated the clinical efficacy, safety, and tolerability of 10 mg and 20 mg of azetukalner in 168 patients with moderate to severe MDD.
Summary of Efficacy Data:
- The primary endpoint of the study was a change in the Montgomery-Åsberg 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, 3.04 difference between placebo and the azetukalner 20 mg groups (P=0.135) was observed.
- At week 1, the mean reduction in MADRS score from baseline (exploratory endpoint) was significantly different between placebo and azetukalner 20 ...