Amylyx Names New Chief Commercial Officer Ahead of GLP-1 Commercialization

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Amylyx Pharmaceuticals named Dan Monahan as its chief commercial officer.¹ According to a press release, he is assuming the role in time to oversee the commercialization of avexitide, a GLP-1 developed by Amylyx for the treatment of post-bariatric hypoglycemia (PBH). FDA granted the drug breakthrough therapy designation for the treatment of PBH and congenital hyperinsulinism (HI).

The drug is still the clinical trial phase and Amylyx plans to launch a Phase III trial in 2025.

In a press release, Monahan said, “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. 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.”

In the same press release, Amylyx co-CEOs Joshua Cohen and Justin Klee said, “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. 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. Since joining Amylyx earlier this year, Mr. Monahan has demonstrated invaluable leadership as we work towards ensuring launch readiness for the avexitide program ahead of Phase 3 data expected in 2026 and potential future launches. We are confident that the addition of Mr. Monahan to our leadership team will play a crucial role in delivering a meaningful impact to the PBH community as we continue to move forward in our goal for avexitide to be the first therapy approved for people living with PBH.”

Amylyx first announced plans for avexitide’s Phase III trial, named LUCIDITY, in December, 2024.² At the time, the company stated that first patients in the study should begin dosing during the first quarter of 2025, with top line results being published in 2026.

In a press release issued at the time, Cohen and Klee said, “We are excited to advance avexitide into a Phase 3 clinical trial, marking a pivotal step toward bringing this investigational therapy to people living with PBH. The consistent data from five clinical trials of avexitide in PBH underscore avexitide’s potential to be the first therapy approved for people living with PBH.”

In the same press release, Amylyx’s chief medical officer Camille L. Bedrosian, MD, said, “PBH is believed to result from an excessive GLP-1 response leading to persistent, recurrent, and debilitating hypoglycemia events that take a profound toll on someone’s quality of life. Avexitide is designed to bind to the GLP-1 receptor and inhibit the effects of excessive GLP-1 in PBH, mitigating hypoglycemia by decreasing insulin secretion and stabilizing blood glucose levels. We are excited to evaluate avexitide, which has FDA Breakthrough Therapy and Orphan Drug Designations, in the Phase 3 LUCIDITY trial, following two Phase 2 clinical studies that demonstrated compelling clinical data supporting avexitide’s ability to significantly reduce the rates of hypoglycemia events. Our goal in Phase 3 is to align the trial design as closely as possible with the prior studies. Importantly, we believe LUCIDITY is well powered to detect a treatment effect. We look forward to continuing to collaborate with study investigators and the PBH community as we seek to initiate LUCIDITY and advance avexitide through the clinical development process.”

Sources

1. Amylyx Pharmaceuticals Appoints Dan Monahan as Chief Commercial Officer. Amylyx. January 6, 2025. https://www.businesswire.com/news/home/20250106578341/en/Amylyx-Pharmaceuticals-Appoints-Dan-Monahan-as-Chief-Commercial-Officer
2. Amylyx Pharmaceuticals Announces Pivotal Phase 3 LUCIDITY Trial Design for GLP-1 Receptor Antagonist (Avexitide) in Post-Bariatric Hypoglycemia. Amylyx. December 4, 2024. Accessed January 9, 2025. https://www.businesswire.com/news/home/20241203046765/en/Amylyx-Pharmaceuticals-Announces-Pivotal-Phase-3-LUCIDITY-Trial-Design-for-GLP-1-Receptor-Antagonist-Avexitide-in-Post-Bariatric-Hypoglycemia