STAT+: Amylyx endocrine drug succeeds in pivotal study

Amylyx Pharmaceuticals said Tuesday that its experimental drug significantly helped patients who experience sudden drops in blood sugar after bariatric surgery, paving the way for its potential approval as the first treatment for the condition.

In a Phase 3 trial of people with post-bariatric hypoglycemia, or PBH, those taking the drug experienced a 55% reduction in the rate of serious low blood sugar events compared with those on placebo. This was better than expected; the study was statistically powered to show a 35% improvement over placebo.

A serious event is a medical emergency that could mean the person loses consciousness or experiences a seizure, so “any reduction in these hypoglycemic events would be very meaningful for people with PBH and their families,” said Amylyx co-CEO Justin Klee. To see such a large effect in the study “is just so exciting.”

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