STAT+: Amylyx endocrine drug succeeds in pivotal study
In a Phase 3 trial of people with post-bariatric hypoglycemia, those taking the drug, avexitide, experienced a 55% reduction in the rate of serious low blood sugar events compared with…
Amylyx Pharmaceuticals announced on Tuesday that its experimental drug demonstrated significant benefits for patients experiencing sudden drops in blood sugar following bariatric surgery, potentially leading to its approval as the first treatment for this condition. The Phase 3 trial involving individuals with post-bariatric hypoglycemia (PBH) revealed a 55% reduction in the occurrence of severe low blood sugar events among those taking the drug compared to those receiving a placebo.
This outcome exceeded expectations, as the study was designed to detect a 35% improvement over placebo. A serious event, such as losing consciousness or having a seizure, is considered highly impactful, with Amylyx co-CEO Justin Klee emphasizing that any reduction in these hypoglycemic episodes would be highly beneficial for those with PBH and their families. The magnitude of this effect in the study was described as "just so exciting."
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