Amylyx Pharmaceuticals Inc.(NASDAQ:AMLX) stock is trading higher on Tuesday after the company released highly favorable topline data from its Phase 3 LUCIDITY clinical trial
Favorable Trial Outcomes
The multicenter study evaluated avexitide, an investigational glucagon-like peptide-1 (GLP-1) receptor antagonist, for patients suffering from post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass surgery
PBH is a late complication of weight-loss surgery (like gastric bypass) where low blood sugar happens 1 to 3 hours after eating
The 78-participant trial successfully met its FDA-agreed primary objective
Treatment with avexitide demonstrated a substantial 55% decrease in the combined rate of Level 2 and Level 3 hypoglycemic episodes over a 16-week period when compared to a placebo
Secondary Endpoints Achieved
During the study, adult participants were randomized to receive either a daily 90 mg subcutaneous injection of avexitide or a placebo
The LUCIDITY trial achieved all secondary targets, displaying statistically significant and consistent declines in Level 2 events, which were tracked by continuous glucose monitoring and self-monitoring of blood glucose
Independently assessed Level 3 events were also meaningfully reduced
Safety Profile And Regulatory Plans
Avexitide remained generally well-tolerated, showing a favorable safety record that aligns with previous PBH clinical trials
Most reported adverse events were mild or moderate, with diarrhea and minor injection site reactions being the most frequent. Researchers observed no serious treatment-related adverse events or notable weight changes during the 16-week timeframe
The company intends to file a New Drug Application with the FDA before the end of 2026, and the company continues to advance preparations for a potential commercial launch of avexitide in 2027
A 32-week open-label extension and an expanded access program remain ongoing
Cash, cash equivalents, and short-term investments were $250.8 million at June 30. Based on its current operating plans, Amylyx expects a cash runway into 2028
AMLX Stock Price Activity: Amylyx Pharmaceuticals shares were up 35.32% at $29.01 during premarket trading Tuesday
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