Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) has appointed Dan Monahan as its Chief Commercial Officer, entrusting him with the commercial strategy for its growing portfolio, with immediate focus on avexitide, a promising therapy for post-bariatric hypoglycemia (PBH). Monahan, who joined Amylyx in January 2024, brings over two decades of commercial leadership experience in the biopharmaceutical sector, with a proven track record in sales, marketing, and market access.
Monahan's Role and Background
In his new role, Monahan will spearhead Amylyx's commercialization efforts, particularly focusing on the potential approval and launch of avexitide. His prior experience includes leadership positions at Otsuka Pharmaceuticals, where he oversaw the commercialization of CNS franchises like REXULTI® and ABILIFY MAINTENA®. He also held senior roles at Novartis, leading the commercial execution of COSENTYX® for autoimmune conditions, and spent 14 years at Sanofi in various leadership roles.
"I look forward to continuing to collaborate with the team on advancing novel therapies from development through commercialization, with our first focus on avexitide for the potential treatment of post-bariatric hypoglycemia," said Dan Monahan, Chief Commercial Officer of Amylyx. "Since joining Amylyx, I have seen first-hand both the resilience of those with post-bariatric hypoglycemia and the significant quality of life impacts that this debilitating condition can have. I am deeply motivated by the opportunity to support people living with PBH and potentially addressing the critical unmet need for a treatment option."
Avexitide and the LUCIDITY Trial
Avexitide is an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist. It has received Breakthrough Therapy Designation from the FDA for both PBH and congenital hyperinsulinism (HI), as well as Orphan Drug Designation for hyperinsulinemic hypoglycemia. The drug is designed to bind to GLP-1 receptors on pancreatic islet beta cells, inhibiting GLP-1's effects and reducing insulin secretion to stabilize blood glucose levels.
Amylyx is preparing to initiate the LUCIDITY trial, a Phase 3 multicenter, randomized, double-blind, placebo-controlled study, in the first quarter of 2025. The trial will evaluate the efficacy and safety of avexitide in 75 participants with PBH across approximately 20 sites in the U.S. Participants will be randomized 3:2 to receive either 90 mg of avexitide subcutaneously once daily or placebo. The primary efficacy objective is the reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16. Topline data from the LUCIDITY trial is expected in 2026.
The Unmet Need in Post-Bariatric Hypoglycemia
Post-bariatric hypoglycemia affects approximately 8% of individuals who have undergone bariatric surgery in the U.S., which translates to roughly 160,000 people. PBH is characterized by an excessive GLP-1 response, leading to hypoglycemia and a diminished quality of life. Patients experience debilitating hypoglycemic episodes due to inadequate glucose supply to the brain, resulting in impaired cognition, loss of consciousness, and seizures. Currently, there are no approved therapies for PBH, underscoring the urgent need for effective treatments.
"We are excited to announce the appointment of Dan Monahan to Chief Commercial Officer as Amylyx prepares for the first participant dosed in the Phase 3 LUCIDITY clinical trial of avexitide for the treatment of post-bariatric hypoglycemia planned in the first quarter of 2025," said Joshua Cohen and Justin Klee, Co-CEOs of Amylyx. "Dan has a strong track record of launching medicines and excels in building and leading high-performing teams that have brought new medicines to communities with high unmet needs."
