Amylyx is looking to rebuild its pipeline portfolio after axing its ALS drug following a failed Phase III trial. Image credit: Shutterstock / sulit.photos.

Amylyx Pharmaceuticals is looking to rebuild its pipeline after dropping Relyvrio and acquiring a Phase III ready glucagon-like peptide 1 receptor antagonist (GLP1-RA), avexitide, from bankrupt Eiger BioPharmaceuticals in a $35.1m deal.

The Phase III trial of the candidate is due to begin in 2025 in hyperinsulinemic hypoglycaemia with data anticipated in 2026. No trials have been conducted in either type 2 diabetes (T2D) or obesity where the field of GLP-1RAs is dominated by pharma giants Novo Nordisk and Eli Lilly.

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Following the announcement, Amylyx’s stock took an initial hit before climbing dramatically, from a close of $1.65 on 9 July, with a 20% rise to a high of $1.98 in the morning of 10 July.

Amylyx announced its intentions to acquire the pipeline candidate from Eiger last month, two months after Eiger filed for bankruptcy in April 2024.

Following the acquisition, Amylyx co-CEOs Joshua Cohen and Justin Klee said that the company has always strived to find treatments for unmet needs.

In a joint statement, the pair said: “Since Amylyx was founded, we have been guided by a rigorous approach to our science to bring potential treatments to communities with high unmet needs. When we reviewed all the compelling data supporting avexitide, it is clearly aligned with our strategic scientific criteria, expertise, and community values, and we are excited to build upon the important work done to date to study this asset.”

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Data from two Phase II studies of avexitide in people with post-bariatric hypoglycaemia (NCT02771574 and NCT03373435) demonstrated highly statistically significant reductions in severe hypoglycaemic events.

Eiger received FDA Breakthrough Therapy Designation and Orphan Drug Designation (ODD) for avexitide for hyperinsulinemic hypoglycaemia. It also received ODD from the European Medicines Agency (EMA) for non-insulinoma pancreatogenous hypoglycaemia syndrome.

Amylyx has removed its lead drug Relyvrio, which received approval for amyotrophic lateral sclerosis (ALS), from the market after it failed to meet any endpoints in a pivotal Phase III trial. It cut 70% of the workforce as a result of the failure.

The company is still investigating candidates for Wolfram syndrome and progressive supranuclear palsy.

Note: The indication has been edited in paragraph 10 post publication.