Breakthrough Therapy Designation Awarded to Amylyx Pharmaceuticals for Avexitide, a Novel Treatment for Hyperinsulinemic Hypoglycemia – Find Out More Here!

Boston, MA – Amylyx Pharmaceuticals, Inc. held a conference call on July 10, 2024, to discuss the acquisition of Avexitide, a novel GLP-1 receptor antagonist developed for the treatment of hyperinsulinemic hypoglycemia. The call featured key company executives and participants from various financial institutions.

The acquisition of Avexitide by Amylyx Pharmaceuticals marks a significant milestone in their pursuit of innovative treatments for high unmet medical needs. The company’s co-CEOs, Josh Cohen and Justin Klee, along with other executives, highlighted the potential of Avexitide in targeting hyperinsulinemic hypoglycemia, a debilitating condition with no approved treatment options.

Avexitide’s unique mechanism of action as a GLP-1 receptor antagonist offers a promising approach to treating conditions associated with hyperinsulinemic hypoglycemia. The Phase III-ready asset has shown great promise in clinical studies, with FDA breakthrough therapy designation in post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism.

During the conference call, executives discussed the criteria for the acquisition of Avexitide, emphasizing its well-defined mechanistic rationale, clear clinical outcomes, and rigorous preclinical data. The potential for Avexitide to address a significant unmet medical need in PBH, affecting an estimated 160,000 individuals in the United States, was underscored.

With plans to initiate a Phase III program for Avexitide in Q1 2025, Amylyx Pharmaceuticals aims to address the severe hypoglycemic events experienced by individuals with PBH. The company’s commercialization strategy and focus on delivering important treatment options to communities with high unmet needs demonstrate their commitment to advancing healthcare innovation.

The discussion during the conference call highlighted the urgency and importance of developing effective treatments for hyperinsulinemic hypoglycemia. Amylyx Pharmaceuticals’ strategic acquisition of Avexitide represents a significant step forward in addressing this challenging medical condition, offering hope for improved outcomes for patients in need.