Amylyx Pharmaceuticals Inc (NASDAQ:AMLX) acquired avexitide from Eiger BioPharmaceuticals Inc (OTC:EIGRQ) for $35.1 million.
Avexitide is an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist that has been evaluated in five clinical trials for post-bariatric hypoglycemia (PBH) and has also been studied in congenital hyperinsulinism (HI), two indications characterized by hyperinsulinemic hypoglycemia.
The FDA has granted avexitide Breakthrough Therapy Designation for both indications, Rare Pediatric Disease Designation in congenital HI, and Orphan Drug Designation for hyperinsulinemic hypoglycemia (which includes PBH and congenital HI).
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Avexitide is designed to bind to the GLP-1 receptor on pancreatic islet beta cells and block the effect of GLP-1 to mitigate hypoglycemia by decreasing insulin secretion and stabilizing glucose levels.
As part of the transaction, Amylyx assumed certain contractual obligations from Eiger, including a 3% royalty on future sales of avexitide in PBH, if approved, to certain academic institutions.
In previous Phase 2 and Phase 2b studies in PBH, avexitide showed statistically significant reductions in hypoglycemic events characterized by low blood glucose.
Amylyx expects to begin the Phase 3 program for avexitide in PBH in Q1 2025.
The results from the Phase 2 PREVENT study showed that, compared with placebo, avexitide 30 mg twice daily (BID) and 60 mg once daily (QD) significantly increased mean plasma glucose nadir (prespecified primary endpoint) and lowered insulin peak, corresponding to 50% and 75% fewer participants requiring rescue during mixed meal tolerance testing, respectively.
Avexitide was generally well tolerated.
A Phase 2b open-label cross-over study of higher dose avexitide (45 mg BID and 90 mg QD) showed that Avexitide reduced the frequency of hypoglycemia by up to 65% and the amount of time in hypoglycemia by up to 64%.
Price Action: AMLX shares are up 21.2% at $1.99 at last check Wednesday.
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