ACCORD-2 Phase 3 trial in Alzheimer’s disease agitation achieves primary endpoint compared to placebo (p=0.001, time to relapse)
ACCORD-2 Phase 3 trial achieves key secondary endpoint compared to placebo (p=0.001, prevention of relapse of Alzheimer’s disease agitation)
AXS-05 reduced worsening of Alzheimer’s disease overall compared to placebo in ACCORD-2 Phase 3 trial (p<0.001, CGI-S Alzheimer’s disease overall clinical status)
ADVANCE-2 trial did not demonstrate statistical significance on primary endpoint; numerically greater improvements with AXS-05 over placebo (primary and secondary endpoints)
Long-term safety trial completed with required number of patients treated for 6 and 12 months
AXS-05 was well tolerated in controlled and long-term trials, and was not associated with death, increased risk of falls, cognitive decline, or sedation
Four completed pivotal, Phase 3, placebo-controlled trials support efficacy and safety of AXS-05 in Alzheimer’s disease agitation
The Company plans to submit a New Drug Application (NDA) to the FDA in 2H 2025
Conference call and webcast to take place today at 8:00 AM Eastern
Axsome will host a conference call and webcast today at 8:00 a.m. Eastern Time to discuss the topline results of the ADVANCE-2 and ACCORD-2 Phase 3 trials of AXS-05 in Alzheimer’s disease agitation. Dr. Jeffrey Cummings, Vice Chair of Research, UNLV Department of Brain Health, will join the call and will be available to answer questions during the Q&A session. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of the conference call can be access on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at axsome.com. A replay of the conference call will be available for approximately 30 days following the live event.
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