Amylyx seeks to fill Relyvrio-sized hole in pipeline with $35M GLP-1 buy

Searching for a path forward after the withdrawal of Relyvrio in amyotrophic lateral sclerosis (ALS), Amylyx Pharmaceuticals has purchased a GLP-1 receptor antagonist from Eiger Biopharma for $35.1 million.

Amylyx emerged victorious after Eiger auctioned off avexitide, which had been under development for post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism (HI), according to a Securities and Exchange Commission document dated June 21.

Eiger filed for bankruptcy in April and entered into a “stalking horse” process to sell off avexitide. An auction was held on June 17 with Amylyx entering into a purchase agreement at the end of the bidding.

Amylyx has agreed to purchase all of Eiger’s rights and interests in development, manufacture and commercialization of the drug.

The purchase represents a change in direction for Amylyx, which rose to prominence in September 2022 with the controversial approval of Relyvrio for ALS. At the time, the company presented evidence that the therapy significantly slowed the loss of physical function in patients with ALS in a randomized, placebo-controlled phase 2 clinical trial.

But in March, Amylyx announced that Relyvrio had failed in a phase 3 trial. The study did not meet any of the primary or secondary endpoints that measured functional improvement of ALS. A month later, Amylyx moved to take the drug off the market.

A request for comment on the GLP-1 purchase was not returned as of publication. But the metabolic space is not new to the company. Relyvrio, also known as AMX0035, is also being studied in Wolfram syndrome, an autosomal recessive neurodegenerative disease that causes early childhood onset of diabetes and other complications.

Amylyx plans to meet with the FDA later this year to discuss interim data of eight adult patients with Wolfram syndrome from a phase 2 trial called Helios. The early data showed that AMX0035 led to improved pancreatic beta cell function, glycemic control and vision. Further data from 12 patients in the mid-stage trial are expected in the fall. 

Besides AMX0035, Amylyx is also developing the antisense oligonucleotide AMX0114 for ALS.