Amylyx Pharmaceuticals, Inc ( AMLX ). on Sunday presented new exploratory analyses from its Phase 2 PREVENT and Phase 2b trials of avexitide—an investigational GLP-1 receptor antagonist—at the Endocrine Society's annual meeting (ENDO 2025).

The drug targets post-bariatric hypoglycemia (PBH), a condition marked by dangerously low blood sugar following weight-loss surgery.

In the Phase 2b trial, a 90 mg once-daily dose of avexitide—now being evaluated in the Phase 3 LUCIDITY trial—achieved a 64% reduction in the rate of moderate to severe hypoglycemic events. More than half of participants experienced no such events during treatment.

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LUCIDITY, a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial, is evaluating the safety and efficacy of avexitide in approximately 75 patients with PBH following Roux-en-Y gastric bypass surgery. The FDA-designated primary endpoint is a reduction in Level 2 and 3 hypoglycemic events.

Previous trials, including Phase 2 PREVENT and Phase 2b, showed consistent, dose-dependent reductions in these events across multiple dosing regimens. Notably, the 90 mg once-daily dose demonstrated sustained 24-hour GLP-1 receptor inhibition, supported by pharmacokinetic and pharmacodynamic data presented at ENDO 2025. In vitro studies confirmed potent target engagement, with avexitide plasma levels exceeding the IC₅₀ threshold throughout the dosing window.

Across five clinical trials, avexitide has shown statistically and clinically meaningful efficacy with a favorable safety profile. LUCIDITY is expected to complete enrollment in 2025, with top-line results anticipated in the first half of 2026 and a potential commercial launch in 2027.

Price Action: AMLX stock is up 7.55% at $8.26 at the last check on Monday.

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