Expert Interview
A second look: Discussing the potential role of Amylyx' Avexitide in post bariatric hypoglycemia (PBH)
Ticker(s): AMLXInstitution: Stanford
- Served as Instructor of Medicine (Endocrinology) at Stanford,
- Dr. Craig’s research interests center on examining the roles of incretin gut hormones on glucose metabolism and weight, and on the development and application of incretin-based therapies for treatment of related conditions. Clinical research has focused on elucidating the role of GLP-1 in mediating hyperinsulinemic hypoglycemia conditions, including post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism (HI), and on the role of GLP-1 in influencing feeding behaviors.
- Accomplished biopharma executive. Directly supported development of various investigational drugs, including peptide injectables and oral small molecules spanning rare and common metabolic and neuro/neuro-endocrine disorders
What is the current SoC for patients with PBH
Added By: wilson_adminWould Avexitide be an attractive option for PBH patients?
Added By: wilson_adminWhat are your thoughts on the strengths and weaknesses of Avexitide’s Phase II data, and why do you think it wasn’t advanced to Phase III under Eiger despite promising results? How do you assess Amylyx’s Phase III study design, including its longer 16-week duration, higher dosing, and inclusion criteria? What level of hypoglycemia reduction would be clinically meaningful, and what are the expected placebo effects in this trial?
Added By: slingshot_insights
How do you view the clinical landscape for post-bariatric hypoglycemia (PBH)? What are your thoughts on the exclusion of sleeve gastrectomy patients in Amylyx’s Phase III study, and how significant is Roux-en-Y gastric bypass as a PBH risk factor? Do you believe GLP-1 receptor agonists could be a viable alternative treatment for PBH, given limited supporting data, and how does Avexitide’s mechanism compare to other emerging options?
What are your thoughts on the competitive landscape for PBH and congenital hyperinsulinism (CHI)? How does Avexitide compare to other therapies in development, such as MBX Biosciences’ long-acting receptor antagonist or Rezolute Medicines’ anti-insulin receptor therapy for CHI? Would a long-acting version of Avexitide be beneficial, or is a daily injection preferable for metabolic diseases? What factors could influence adoption, such as safety, pricing, and payer considerations?
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