Amylyx Pharmaceuticals has presented new exploratory analyses from the Phase II PREVENT and Phase IIb trials of the investigational glucagon-like peptide-1 (GLP-1) receptor antagonist, avexitide, for post-bariatric hypoglycaemia (PBH) treatment.
The data was presented at the Endocrine Society’s annual meeting, ENDO 2025.
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In the Phase IIb study, a one-time daily dose of 90mg of avexitide resulted in a 64% least-squares (LS) mean decrease in the composite rate of Level 2 and Level 3 hypoglycaemic events in patients, compared to baseline. Over 50% of subjects did not experience any events during the treatment duration. This dosage is currently under assessment in the pivotal Phase III LUCIDITY trial.
The randomised, multicentre, placebo-controlled, double-blind LUCIDITY study aims to evaluate the safety and efficacy of avexitide in approximately 75 PBH subjects after Roux-en-Y gastric bypass surgery.
The primary endpoint agreed upon with the Food and Drug Administration (FDA) is a reduction in the composite of Level 2 and Level 3 hypoglycaemic events.
A consistent decrease in the composite rate of Level 2 and Level 3 hypoglycaemic events was also seen with 45mg twice daily, which was examined in the Phase IIb trial. The Phase II PREVENT trial assessed 30mg twice a day and 60mg once a day.
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By GlobalDataThe presentation also included new pharmacokinetic (PK) and pharmacodynamic (PD) data demonstrating that 90mg of avexitide once a day maintains continuous pharmacologic activity over 24 hours.
The LUCIDITY trial was built upon the data from five PBH trials of the therapy, which have shown dose-dependent effects, including reductions in hypoglycaemic events.
The therapy was found to be well-tolerated across trials, with a favourable safety profile. Recruitment completion for LUCIDITY is anticipated this year, with a data readout expected in the first half of 2026.
On approval, a commercial launch is expected in 2027.
Amylyx Pharmaceuticals chief medical officer Camille Bedrosian said: “The data presented show that, in an exploratory analysis from the Phase II PREVENT and Phase IIb clinical trials, avexitide significantly reduced the composite rate of Level 2 and 3 hypoglycaemic events, including at the 90mg once daily dose that is being studied in our pivotal Phase III LUCIDITY trial.
“We are particularly encouraged that over half of participants did not experience Level 2 or Level 3 hypoglycaemic events during the treatment period. In addition, the pharmacokinetic and pharmacodynamic data demonstrated continuous pharmacologic activity of avexitide 90mg once daily dose over 24 hours.”
In April 2025, Amylyx dosed the first subject in the Phase I LUMINA trial, investigating AMX0114, a potential treatment for amyotrophic lateral sclerosis (ALS).
