On Tuesday, Axsome Therapeutics Inc AXSM mentioned AXS-12 statistically considerably diminished the frequency of cataplexy assaults in comparison with placebo (p=0.017, major endpoint) in Part 3 ENCORE trial.
AXS-12 was additionally properly tolerated with long-term dosing, and its security profile was in keeping with that noticed in beforehand accomplished trials.
The first endpoint was achieved with sufferers randomized to modify to placebo experiencing a imply enhance of 10.29 cataplexy assaults per week in comparison with a imply enhance of 1.32 assaults per week for sufferers randomized to proceed AXS-12 remedy at 3 weeks (p=0.017).
Additionally Learn: Axsome Therapeutics’ CNS Portfolio Poised for Main Development – Analyst Predicts Robust Future
AXS-12 resulted in statistically important profit in cognition in comparison with placebo.
A better variety of sufferers who switched to placebo skilled worsening on the NSAQ Potential to Focus merchandise in comparison with these persevering with on AXS-12 (52.6% versus 14.3%) at 3 weeks (p=0.011).
A statistically important enchancment in narcolepsy total was noticed in comparison with placebo.
Extra sufferers randomized to modify to placebo reported worsening of their narcolepsy in comparison with these persevering with on AXS-12 (52.6% versus 16.7%) at 3 weeks (p=0.024).
In the course of the long-term open-label remedy portion of the trial, sufferers skilled substantial and sustained enchancment of cataplexy with AXS-12 remedy.
Sufferers skilled a 71% discount from baseline in imply weekly cataplexy assaults at 1 month with AXS-12 remedy, which was sustained with long-term remedy, leading to a 77% discount at 6 months.
Lengthy-term open-label remedy with AXS-12 resulted in substantial enhancements in extreme daytime sleepiness. Imply scores had been diminished by 5.6 factors at 1 month, with this enchancment maintained with long-term remedy, leading to a imply discount of seven.3 factors at 6 months.
William Blair views the protection profile of AXS-12 as a key differentiator from Jazz Prescription drugs plc’s JAZZ Xyrem. The analyst reiterates the Outperform score on Axsome.
“Finally, we imagine AXS-12 is each an approvable and efficient remedy, with the information launched as we speak constructing on each the efficacy and long-term security of the product,” the analyst writes.
William Blair conservatively fashions $440 million in peak AXS-12 gross sales, relative to rising Wakix gross sales of $582 million in 2023, and says the asset is undervalued with investor give attention to information for AXS-05 in Alzheimer’s illness agitation anticipated earlier than year-end.
Worth Motion: AXSM inventory is up 2.5% at $99.46 ultimately test Wednesday.
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