Amylyx Acquires Promising GLP-1 Antagonist for Hypoglycemia Treatment

Amylyx Pharmaceuticals has acquired avexitide, a Phase 3-ready GLP-1 receptor antagonist with FDA Breakthrough Therapy Designation for treating hyperinsulinemic hypoglycemia.

Key points:

  • Avexitide has shown significant reductions in hypoglycemic events in Phase 2 trials for post-bariatric hypoglycemia (PBH).
  • Amylyx plans to begin Phase 3 trials for avexitide in PBH in Q1 2025, with data expected in 2026.
  • The acquisition aligns with Amylyx’s focus on developing treatments for high unmet medical needs in endocrine and neuroscience areas.

Market estimate: The hypoglycemia treatment market is forecast to rise to approximately $510 billion in sales by 2025, per BioMediaHub’s estimate.

_________________________________

Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) has announced the acquisition of avexitide, a novel GLP-1 receptor antagonist, from Eiger BioPharmaceuticals, Inc. This strategic move expands Amylyx’s pipeline in the endocrine and neuroscience fields, focusing on addressing unmet medical needs.

Breakthrough Therapy

Avexitide has received FDA Breakthrough Therapy Designation for both post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism. These conditions are characterized by hyperinsulinemic hypoglycemia, which can lead to severe hypoglycemic events if left untreated.

Promising Clinical Results

In Phase 2 trials, avexitide demonstrated significant efficacy in treating PBH:

  • Reduced hypoglycemic events: The drug showed statistically significant reductions in hypoglycemic events, including severe episodes requiring assistance.
  • Improved glucose control: Avexitide increased mean plasma glucose nadir and lowered insulin peaks compared to placebo.
  • Safety profile: The treatment was generally well-tolerated across five clinical trials in PBH patients.

Path Forward

Amylyx plans to initiate a Phase 3 program for avexitide in PBH in the first quarter of 2025, with data expected in 2026. The company is also exploring potential applications for congenital hyperinsulinism based on promising Phase 2 results.

Management’s Perspective

Joshua Cohen and Justin Klee, Co-CEOs of Amylyx, expressed enthusiasm for the acquisition, stating that avexitide aligns with their strategic scientific criteria, expertise, and community values.

Takeaway

The acquisition of avexitide represents a significant step for Amylyx in expanding its pipeline and addressing critical unmet needs in endocrine disorders.

With its promising clinical results and FDA Breakthrough Therapy Designation, avexitide has the potential to become an important treatment option for patients suffering from hyperinsulinemic hypoglycemia.

Wooden blocks that spell obesity.

Subscribe

Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors

BioMediaHub Logo