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Jump to Key Points Aug 18 (Reuters) - Amylyx Pharmaceuticals' experimental drug sharply reduced dangerously low blood sugar episodes in a late-stage trial of patients who underwent weight-loss surgery, sending its shares up more than 45% on Tuesday.
There are no approved treatments for post-bariatric hypoglycemia, a condition that can develop after Roux-en-Y gastric bypass, a common weight-loss procedure, and can cause cognitive impairment, loss of consciousness or seizures.
In the 78-patient trial, avexitide, a once-daily injection, reduced hypoglycemic episodes by 55% versus placebo over 16 weeks, meeting the main goal, Amylyx said.
The reduction was a "best-case scenario" and better than investors expected, Stifel analyst James Condulis said.
- Avexitide ↓ hypoglycemic episodes 55% vs placebo over 16 weeks.
- 78-patient late-stage trial; once-daily injection met primary endpoint.
- Post-bariatric hypoglycemia lacks approved therapies after Roux-en-Y gastric bypass.
- Condition may cause cognitive impairment, LOC, or seizures.
- Avexitide well-tolerated; AEs mainly diarrhea and bruising.
Patients "want more than anything to reduce the number of hypoglycemia events so that they can live independently without the fear," Dr. Marilyn Tan, the study's lead investigator, said on a call with analysts.
The condition is typically managed through dietary changes, blood sugar monitoring and carbohydrate-blocking medications.
Avexitide, which blocks certain GLP-1 receptors in the pancreas to reduce excess insulin secretion and stabilize blood glucose levels, was well-tolerated with mild-to-moderate side effects such as diarrhea and bruising, the company said.
Amylyx's stock rose to $31.72 in morning trading, on track to add roughly $1.15 billion to its market value if gains hold.
A CRUCIAL TURNAROUND
The results mark a vital turnaround for Amylyx, which was forced to pull its flagship ALS drug, Relyvrio, from the market in 2024 following a late-stage trial failure that led to layoffs and a corporate restructuring.
With $250 million in cash on hand, Amylyx said it is moving "expeditiously" toward a U.S. marketing application by the end of this year, aiming for a 2027 commercial launch.
TD Cowen analysts projected peak U.S. sales of $2.2 billion for avexitide.
Amylyx acquired avexitide from Eiger BioPharmaceuticals for $35.1 million in 2024 during Eiger's bankruptcy auction.
Attention now shifts to "filing acceptance, label breadth, and launch execution in an underrecognized market," Citi analyst Geoffrey Meacham said.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Vijay Kishore)
