Aug 18 (Reuters) – Amylyx Pharmaceuticals’ experimental drug met its main goal in a late-stage trial for post-bariatric hypoglycemia, a condition marked by dangerously low blood sugar levels following weight-loss surgery, sending its shares up over 30% in premarket trading on Tuesday.
In the 78-patient trial, the once-daily injection avexitide reduced low blood sugar episodes by 55% versus placebo over the 16-week study, Amylyx said.
H.C. Wainwright analysts, earlier this month, had forecast a 35% to 50% reduction as the “plausible band” for an encouraging outcome.
Post-bariatric hypoglycemia can cause significant cognitive or physical impairment, loss of consciousness or seizures, and affects about 8% of weight-loss surgery patients in the United States, according to Amylyx.
Avexitide works by blocking GLP-1 receptors on the insulin-producing cells in the pancreas to reduce excess insulin secretion and stabilize blood glucose levels.
The drug was well-tolerated, with the most common side effects being mild to moderate, including diarrhea and bruising at the injection site, the company said.
There were no changes in body weight observed in either the avexitide or placebo groups over the treatment period, the company said.
There are currently no approved treatments for the condition, and patients usually manage the disease through dietary changes, blood sugar monitoring and carbohydrate-blocking medications.
The company plans to submit the drug for U.S. regulatory approval by the end of this year, aiming for a potential commercial launch in 2027.
TD Cowen analysts projected peak U.S. sales of $1.5 billion for avexitide.
Amylyx acquired avexitide from Eiger BioPharmaceuticals for $35.1 million in 2024 during Eiger’s bankruptcy auction.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Vijay Kishore)
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