Amylyx Pharmaceuticals’ $35m bet on Eiger BioPharmaceuticals’ glucagon-like peptide-1 (GLP-1) receptor antagonist for post-bariatric hypoglycaemia (PBH) has paid off after a Phase III trial met its primary endpoint.
The multicentre, randomised, double-blind, placebo-controlled LUCIDITY trial (NCT06747468) of avexitide enrolled 78 patients with PBH following Roux-en-Y gastric bypass (RYGB) surgery.
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LUCIDITY met the US Food and Drug Administration (FDA)-agreed primary endpoint, demonstrating a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycaemic events with patients who received avexitide compared to placebo after 16 weeks.
The trial also met all secondary endpoints, demonstrating consistent, highly statistically significant, and clinically meaningful reductions in Level 2 hypoglycaemic events with self-monitoring of blood glucose (SMBG) and continuous glucose monitoring (CGM), as well as in Level 3 hypoglycaemic events.
The majority of adverse events (AEs) in LUCIDITY were mild to moderate, and no serious AEs related to avexitide were reported. The most common AEs were diarrhoea, injection site erythema, and injection site bruising.
Amylyx noted there were no changes in body weight observed in either group during the double-blind period of the LUCIDITY trial, which is continuing for a 32-week open-label extension (OLE) period.
Dr Marilyn Tan, principal investigator of LUCIDITY and clinical professor at the Stanford School of Medicine, said: “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.”
Based on this data, Amylyx hopes to submit a New Drug Application (NDA) to the FDA by the end of 2026. The drug has previously been granted breakthrough therapy designation for PBH from the FDA.
PBH is a late complication of weight-loss surgery, such as a gastric bypass. It happens when blood sugar drops too low two to four hours after a meal. Currently, PBH patients are treated off-label with potassium channel opener drugs such as diazoxide. However, these treatments tend to have poor tolerability. The approval of avexitide would mark the first targeted drug for PBH.
After Amylyx announced the Phase III data, its stock skyrocketed by 63.84%, from a 17 August close of $21.43 to an 18 August close of $35.11. Amylyx is listed on the Nasdaq exchange with a market cap of $3.9bn.
Amylyx acquired the PBH drug for $35.1m through the 2024 bankruptcy proceedings of Eiger BioPharmaceuticals. GlobalData does not anticipate it will take the company long to gain its investment back, as it expects the drug to reach over $100m in sales in its first year on the market.
GlobalData is the parent company of Clinical Trials Arena.
