On Monday, Axsome Therapeutics, Inc. AXSM launched information from ACCORD-2, ADVANCE-2, and long-term security trials AXS-05 (dextromethorphan-bupropion) in Alzheimer’s illness agitation.
The ACCORD-2 Part 3 trial achieved the first endpoint with AXS-05 statistically considerably delaying the time to relapse of agitation, demonstrating a 3.6-fold decrease danger of relapse in comparison with placebo.
AXS-05 additionally met the important thing secondary endpoint (relapse prevention, p=0.001). Additional, AXS-05 decreased the worsening of general Alzheimer’s illness severity in comparison with the placebo.
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The ADVANCE-2 Part 3 trial didn’t reveal statistical significance for the first endpoint in delaying the time to relapse of agitation from baseline to Week 5, with reductions of 13.8 and 12.6 factors for AXS-05 and placebo, respectively.
Nonetheless, outcomes for the first and almost all secondary endpoints numerically favored AXS-05 over placebo.
AXS-05 was protected and nicely tolerated in each managed research.
The long-term security and tolerability of AXS-05 have been additionally evaluated in additional than 300 topics handled for a minimum of 6 months and greater than 100 handled for a minimum of 12 months.
Within the managed and long-term research in topics with Alzheimer’s illness, AXS-05 was not related to an elevated danger of falls, cognitive decline, or sedation.
Within the medical program for AXS-05 in Alzheimer’s illness agitation, there have been no deaths in topics receiving AXS-05.
Axsome plans to submit an NDA for AXS-05 in Alzheimer’s illness agitation to the FDA within the second half of 2025.
William Blair writes that the info from the trials symbolize a blended state of affairs for buyers to digest how regulators will interpret the full pivotal information bundle for AXS-05 in Alzheimer’s illness agitation.
The analyst notes that neuropsychiatry medicine have been accepted based mostly on their general information, even when they confronted setbacks in key trials.
Examples embody Intra-Mobile Therapies Inc’s ITCI Caplyta and Johnson & Johnson’s JNJ esketamine.
William Blair notes the approval of Otsuka Holdings Co Ltd OTSKY OTSKF Rexulti for Alzheimer’s-related agitation, regardless of blended trial outcomes, is a powerful comparability for Axsome’s AXS-05.
Nonetheless, a key distinction is that Rexulti’s approval relied on placebo-controlled parallel group research, whereas Axsome is predicted to rely upon outcomes from the ADVANCE-1 and ACCORD-1/2 trials to satisfy the FDA’s requirement for 2 well-controlled research.
The analyst stays optimistic about AXS-05’s approval, highlighting that the FDA’s continued designation of AXS-05 as a breakthrough remedy displays the excessive unmet want on this space, which may work in Axsome’s favor.
Value Motion: AXSM inventory is up 2.62% to $87.00 premarket on the final verify on Tuesday.
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