Xenon Pharmaceuticals Announces Topline Results from Phase 2 Proof-of-Concept X-NOVA Clinical Trial of XEN1101 in Major Depressive Disorder (MDD) - Seite 2

Ian Mortimer, Xenon’s President and Chief Executive Officer stated, “Based on the totality of data from this study, including clinically meaningful drug activity in depression and anhedonia, we are actively exploring the future development of XEN1101 in MDD and potentially other indications as we believe this mechanism has potential broad applicability.”

Mr. Mortimer continued, “We believe that the data from this study in depression further build upon XEN1101’s compelling product profile in our ongoing Phase 3 development in epilepsy. Data to date support XEN1101’s potential to combine many key features important in treating epilepsy including compelling efficacy in focal onset seizures, rapid efficacy as demonstrated by statistically significant seizure reduction at week 1, a novel mechanism of action with no titration required and other ease of use attributes. We believe the new clinical data we have generated through X-NOVA further support the potential of XEN1101 to have a highly differentiated profile in the treatment of epilepsy given the significant co-morbidity of depression in epilepsy patients. We are excited to share the data generated in X-NOVA with epileptologists and neurologists at the upcoming American Epilepsy Society meeting in December.”

About the Phase 2 X-NOVA Clinical Trial in MDD

The Phase 2 proof-of-concept X-NOVA clinical trial evaluated the clinical efficacy, safety and tolerability of 10 mg or 20 mg of XEN1101 administered as monotherapy with food in patients with MDD. Designed as a randomized, double-blind, placebo-controlled, multicenter clinical study, the primary objective was to assess the efficacy of XEN1101 compared to placebo on improvement of depressive symptoms in subjects diagnosed with moderate to severe MDD, using the MADRS score change through week six. The X-NOVA study included a total of 168 randomized subjects, 167 treated subjects in the safety population, and 164 subjects in the modified intent to treat population for the efficacy analyses. The mean MADRS total scores at baseline were 34.2 for the XEN1101 10 mg group, 33.1 for the XEN1101 20 mg group and 34.5 for the placebo group, representing patients with moderate to severe MDD. Other baseline demographic characteristics were also similar across treatment arms.