AEON Biopharma, a clinical-stage biopharmaceutical company, has recently reported that its Phase 2 trial for
ABP-450, a
botulinum toxin complex for
chronic migraine prevention, did not achieve its primary goal. The trial, which involved 325 patients, aimed to measure the mean reduction in monthly migraine days over 13 to 24 weeks. The results showed a decrease of 8.5 days in the 150 U arm, 7.7 days in the 195 U arm, and 8.4 days in the placebo arm, with no statistical significance between the active and placebo groups.
The company expressed surprise at the outcome, as the reduction in migraine days in the active arms was in line with expectations, but the placebo arm's reduction was higher than anticipated based on past research. No secondary endpoints were statistically significant either.
AEON will now analyze the complete data set to understand the unexpected placebo effect and decide the future course of ABP-450's development. The company has initiated cash preservation measures and will consider all strategic options.
AEON's President and CEO, Marc Forth, thanked the trial participants, clinical investigators, and the AEON team for their efforts. He also mentioned that additional analyses are underway to interpret the interim data better.
AEON is developing ABP-450 for various medical conditions, with a focus on the neurosciences market. The botulinum toxin complex is manufactured by
Daewoong and is the same as that marketed by
Evolus for cosmetic purposes under the brand Jeuveau. AEON holds exclusive rights for therapeutic uses of ABP-450 in several regions, including the United States, Canada, the European Union, and the United Kingdom.
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