Amylyx Enters GLP-1 Market, Buys Phase III Asset from Eiger

Amylyx Pharmaceuticals has recently acquired avexitide, a glucagon-like peptide-1 (GLP-1) receptor antagonist, from Eiger BioPharmaceuticals. This acquisition, made for $35 million, comes as Eiger navigates Chapter 11 proceedings with plans to liquidate its assets. Avexitide, which has been granted FDA Breakthrough Therapy Designation, is poised for Phase III trials targeting post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism (HI).

Amylyx aims to integrate avexitide into its development pipeline, with plans to initiate Phase III studies for PBH by the first quarter of 2025. The company also intends to engage with the HI community to launch a Phase II trial at the Children’s Hospital of Philadelphia. According to Josh Cohen, co-CEO of Amylyx, the goal is to obtain Phase III data by 2026 and bring the drug to market by 2027.

Avexitide has already undergone five clinical trials for PBH and has shown promising results, including a statistically significant reduction in hypoglycemic events characterized by low blood glucose. The drug has also been studied for congenital HI and has received FDA Orphan Drug Designation for hyperinsulinemic hypoglycemia and a Rare Pediatric Disease Designation for congenital HI.

Justin Klee, co-CEO of Amylyx, emphasized that the company is actively seeking assets with a clear mechanism of action to address high unmet medical needs. Klee highlighted that while GLP-1 agonists are beneficial for conditions with excessive glucose and insufficient insulin, certain diseases feature the opposite problem—excessive insulin and insufficient glucose. Avexitide is designed to counter such conditions.

Amylyx’s move into the GLP-1 space follows a challenging period for the company. Earlier this year, it decided to withdraw its ALS drug Relyvrio from the market and implemented a restructuring plan that included cutting around 70% of its workforce. This decision was driven by the failure of Relyvrio in its Phase III PHOENIX trial, where it did not outperform a placebo in improving scores on the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale at 48 weeks and failed to meet its secondary endpoints.

Despite these setbacks, Amylyx is concentrating on advancing its lead asset, AMX0035, for adults with Wolfram syndrome. A Phase II study conducted in April 2024 demonstrated that AMX0035 could enhance pancreatic function and improve glycemic control, providing a hopeful outlook for the company's future endeavors.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!