Axsome Therapeutics reports positive AXS-05 data in depression patients

 

• Axsome Therapeutics (NASDAQ:AXSM) announces positive results from the open-label Phase 2 COMET-SI trial of AXS-05 in patients with major depressive disorder (MDD) who have suicidal ideation (SI).
• The COMET-SI trial evaluated 37 patients. A rapid reduction in suicidal ideation was seen, demonstrated by reductions in the MADRS-SI score of 67.6% by Week 1, 73.5% by Week 2, and 82.4% by Week 4. The mean MADRS-SI and MADRS score at baseline was 3.4 and 36.8, respectively.
• Resolution of suicidal ideation with AXS-05 treatment was achieved by 60.0% of patients by Week 1, 68.8% by Week 2, and 77.8% of patients by Week 4. Resolution was defined as a MADRS-SI score of 0 or 1 on a 0 to 6 scale.
• Integrated analysis from these trials demonstrated rapid reduction in MADRS-SI scores with AXS-05 compared to placebo or active control, which was statistically significant at Week 1, (p=0.001 versus control).
• The improvement in suicidal ideation was accompanied by rapid, substantial, and durable improvement in functional impairment, as measured by the Sheehan Disability Scale (SDS).
• Functional response on the SDS was achieved after treatment with AXS-05 by 51.4% of patients at Week 1, 62.5% at Week 2, and 76.9% at Week 6. Mean SDS score was 21.2 at baseline.
• Marked or moderate improvement in depressive symptoms was achieved by 40.0% of patients at Week 1, 59.4% at Week 2, and 69.2% at Week 6.
• Patients experienced a mean reduction from baseline in the MADRS total score of 12.9, 17.8 and 22.8 points at Week 1, 2, at Week 6, respectively.
• Clinical response was achieved by 25.7%, 46.9% and 69.2% of patients at Week 1, 2, and Week 6, respectively.
• Remission from depression was achieved by 11.4% of patients at Week 1, 28.1% at Week 2, and 50% at Week 6.
• AXS-05 was well tolerated with safety profile consistent with that of previous controlled trials of AXS-05 in MDD.
• https://seekingalpha.com/news/3642390-axsome-therapeutics-reports-positive-axsminus-05-data-in-depression-patients