Amylyx’s avexitide met the primary endpoint in the Phase III LUCIDITY trial, producing a 55% reduction in the composite rate of Level 2 and Level 3 post‑bariatric hypoglycaemic events versus placebo at 16 weeks. All secondary endpoints were achieved, with reductions confirmed by both SMBG and CGM. The drug was generally well tolerated with mostly mild‑to‑moderate AEs and no serious AEs related to treatment. Amylyx plans to file an NDA by the end of 2026; avexitide holds Breakthrough Therapy status for PBH.
Avexitide Cuts Severe Post‑Bariatric Hypoglycaemia By 55% — Amylyx Eyes FDA Filing After Phase III Win
Amylyx hopes to submit a New Drug Application to the FDA by the end of 2026. Credit: T. Schneider / Shutterstock.com
Amylyx Pharmaceuticals' $35.1m acquisition of avexitide has delivered a major clinical win: the Phase III LUCIDITY trial met its pre-agreed primary endpoint, showing a clinically meaningful reduction in severe post‑bariatric hypoglycaemia (PBH) compared with placebo.
Trial Design And Primary Results
The multicentre, randomised, double‑blind, placebo‑controlled LUCIDITY trial (NCT06747468) evaluated avexitide in 78 patients who developed PBH after Roux‑en‑Y gastric bypass (RYGB). After 16 weeks, the study met the FDA‑agreed primary endpoint, demonstrating a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycaemic events for patients receiving avexitide versus placebo.
Secondary Endpoints And Monitoring
All secondary endpoints were also achieved. The trial reported consistent, highly statistically significant and clinically meaningful reductions in Level 2 hypoglycaemic events measured by both self‑monitoring of blood glucose (SMBG) and continuous glucose monitoring (CGM), as well as reductions in Level 3 events.
Safety And Tolerability
Most adverse events (AEs) were mild to moderate. Investigators reported no serious AEs attributed to avexitide. The most frequently observed AEs were diarrhoea, injection‑site erythema, and injection‑site bruising. No meaningful changes in body weight were seen in either group during the double‑blind period.
Next Steps
LUCIDITY is continuing into a 32‑week open‑label extension (OLE). Based on the Phase III data, Amylyx plans to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) by the end of 2026. Avexitide previously received Breakthrough Therapy designation from the FDA for PBH.
Level 2 and Level 3 hypoglycaemic events can be medical emergencies that result in significant cognitive or physical impairment, loss of consciousness, seizures, and the need for assistance from others, underscoring the need for an FDA‑approved treatment option. Preventing even one Level 2 or Level 3 event is medically meaningful. — Dr Marilyn Tan, Principal Investigator, LUCIDITY; Clinical Professor, Stanford School of Medicine
Market Reaction And Background
Following the announcement, Amylyx’s stock climbed roughly 64%, rising from a close of $21.43 on 17 August to $35.11 on 18 August. Amylyx trades on Nasdaq and had an approximate market capitalisation of $3.9bn at the time of the report. Amylyx acquired the asset for $35.1m during Eiger BioPharmaceuticals’ 2024 bankruptcy process.
Market intelligence firm GlobalData (parent company of Clinical Trials Arena) projects avexitide could exceed $100m in sales in its first year, suggesting the acquisition may be recouped quickly if approval is obtained. If approved, avexitide would be the first targeted therapy specifically indicated for PBH.
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