Xenon Pharmaceuticals Inc XENE reported topline results from the Phase 2 proof-of-concept X-NOVA trial, which evaluated the clinical efficacy, safety, and tolerability of 10 mg and 20 mg of XEN1101 in 168 patients with moderate to severe major depressive disorder (MDD).
- The study's primary endpoint was a change in the Montgomery-Åsberg Depression Rating Scale (MADRS) at week 6. The mean reduction was 13.90 in the placebo group, 15.61 in the XEN1101 10 mg group, and 16.94 in the XEN1101 20 mg group.
- A dose-response and a clinically meaningful, but not statistically significant, 3.04 difference between placebo and the XEN1101 20 mg group (p=0.135) was observed.
- Statistical significance was achieved on the pre-specified endpoint of the Hamilton Depression Rating Scale (HAM-D17) at week 6 with a mean reduction of 10.18 in the placebo group and 13.26 in the XEN1101 20 mg group (p=0.042).
- Statistical significance was achieved on the key secondary endpoint of a change in the Snaith-Hamilton Pleasure Scale (SHAPS), measuring anhedonia at week 6 with a reduction of 5.30 in the placebo group and 7.77 in the XEN1101 20 mg group (p=0.046).
- Statistical significance was achieved in MADRS at week 1 with a mean reduction of 4.88 in the placebo group and 7.54 in the XEN1101 20 mg group (p=0.047), demonstrating early onset of efficacy.
- 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 (CGI-I) (p=0.004) in the XEN1101 20 mg group compared to placebo.
XEN1101 was well tolerated, with similar rates of adverse events reported across all treatment arms.
Price Action: XENE shares are up 13.15% at $32.78 on the last check Monday.
Photo Via Company
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in