US-based biopharmaceutical company Amylyx Pharmaceuticals has acquired Eiger BioPharmaceuticals’ investigational diabetes drug avexitide in a $35.1m deal.
Avexitide is a glucagon-like peptide-1 (GLP-1) receptor antagonist with the potential to treat indications of hyper-insulinemic hypoglycaemia.
It works by binding to the GLP-1 receptor on pancreatic islet beta cells to mitigate hypoglycemia by decreasing insulin secretion and stabilising glucose levels.
The drug has been evaluated in five clinical trials for post-bariatric hypoglycaemia (PBH) and congenital hyperinsulinism (HI), two indications related to hyper-insulinemic hypoglycaemia.
Avexitide has received the US Food and Drug Administration (FDA) Breakthrough Therapy Designation for both indications.
It has also received FDA Rare Pediatric Disease Designation in congenital HI, and Orphan Drug Designation for the treatment of hyperinsulinemic hypoglycemia including PBH and HI).
Amylyx co-CEOs Joshua Cohen and Justin Klee 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 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.”
Amylyx intends to begin the Phase 3 studies on avexitide in PBH, in the first quarter of 2025.
The company is actively engaging in discussions with the broader congenital HI community, including experts in the field, to develop a development path.
The development will be based on promising results from the Phase 2 studies conducted at Children’s Hospital of Philadelphia.
Amylyx will add avexitide to its current pipeline programs that are in research and development.
The programmes include AMX0035 for the treatment of Wolfram syndrome, AMX0035 for the treatment of progressive supranuclear palsy, and AMX0114 amyotrophic lateral sclerosis (ALS).
Amylyx chief medical officer Camille Bedrosian said: “We look forward to advancing this critical work with avexitide into Phase 3 for individuals with PBH based on the totality of data from five clinical trials and informed by our ongoing work to address endocrine and metabolic aspects of Wolfram syndrome.
“We also are continuing our conversations with the congenital HI community regarding the clinical development of avexitide in congenital HI to develop a path forward.
“While we are excited to study this new scientific pathway in hyperinsulinemic hypoglycemia, our research in ALS and other neurodegenerative diseases continues through our AMX0035 and AMX0114 programs, guided by the understanding that people living with these devastating diseases have no time to wait – we must continue to research and collaborate with urgency.”
