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Amylyx Pharmaceuticals to Host Event to Discuss Post-bariatric Hypoglycemia and Avexitide at ENDO 2025

via Business Wire

Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that it will host an investor event at the Endocrine Society’s annual meeting (ENDO 2025) on Sunday, July 13, 2025, at 6:00 p.m. PT, both in-person in San Francisco, California and virtually. Speakers will discuss the current burden of post-bariatric hypoglycemia (PBH) and background on avexitide, a potential first-in-class GLP-1 receptor antagonist with FDA breakthrough therapy designation. Speakers will also review new exploratory analyses from the Phase 2 PREVENT and Phase 2b clinical trials of avexitide in post-bariatric hypoglycemia, which will be presented during ENDO 2025. These data include composite rates of Level 2 and 3 hypoglycemic events in both trials as well as new pharmacokinetic (PK) and pharmacodynamic (PD) data demonstrating continuous pharmacologic activity of the 90 mg once daily dose regimen for a 24-hour period.

Amylyx’ management team will be joined by the following experts at the event:

  • Marilyn Tan, MD, FACE, Principal Investigator of the LUCIDITY clinical trial, Co-Lead Investigator of the Phase 2 PREVENT Clinical Trial, and Clinical Associate Professor of Medicine at Stanford University School of Medicine
  • Helen Lawler, MD, Investigator on the LUCIDITY Clinical Trial, Co-Lead Investigator of the Phase 2 PREVENT Clinical Trial, and Associate Professor of Medicine in Endocrinology at University of Colorado at Denver School of Medicine
  • Colleen Craig, MD, Co-lead Investigator of Proof-of-Concept and First-in-Human Studies of Avexitide in PBH, led the avexitide development program during the Phase 2 PREVENT Clinical Trial, and Scientific Advisor and Consultant for Amylyx

Details of Amylyx’ presentations at ENDO 2025 are as follows:

Poster Title: Population PK (PopPK) and Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis of Avexitide in Individuals with Post-Bariatric Hypoglycemia (SAT-559)

Presenter: Kelly Fox, MD, Director, Medical Affairs at Amylyx

Poster Session Date, Time, and Location: Saturday, July 12, 2025, from 12:15-1:45 p.m. PT in the ENDO Expo Poster Area

Rapid Fire Oral Presentation and Poster Title: Reduction in Rate of Hypoglycemic Events with Avexitide in Post-Bariatric Hypoglycemia: Results from the Phase 2 and 2b Studies (SUN-627 / RF19-03)

Presenter: Marilyn Tan, MD, FACE, Principal Investigator of the LUCIDITY clinical trial and Clinical Associate Professor of Medicine at Stanford University School of Medicine

Poster Session Date, Time, and Location: Sunday, July 13, 2025, from 12:00-1:30 p.m. PT in the ENDO Expo Poster Area

Oral Presentation Session Date, Time, and Location: Sunday, July 13, 2025, from 1:55-2:00 p.m. PT in Room 153

Abstracts are available on the Endocrine Society website. The presentation and posters will be made available on the “Presentations” tab of the Amylyx website following the conclusion of the sessions.

The pivotal Phase 3 LUCIDITY trial of avexitide in PBH is underway. Completion of recruitment for LUCIDITY is expected in 2025, with a data readout anticipated in the first half of 2026 and, if approved, commercial launch anticipated in 2027.

Webcast Information

Amylyx will host an investor event on Sunday, July 13, 2025, at 6:00 p.m. PT in San Francisco to discuss post-bariatric hypoglycemia and avexitide. A live webcast of the presentation and Q&A portion of the event can be accessed under “Events and Presentations” in the Investor section of the Company’s website, https://investors.amylyx.com/events-presentations. The webcast will be archived and available for replay for 90 days following the event.

About Avexitide

Avexitide is an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist that has been evaluated in five Phase 1 and Phase 2 clinical trials for post-bariatric hypoglycemia (PBH) and has also been studied in congenital hyperinsulinism (HI). The U.S. Food and Drug Administration (FDA) has granted avexitide Breakthrough Therapy Designation for both indications, Rare Pediatric Disease Designation in congenital HI, and Orphan Drug Designation for the treatment of hyperinsulinemic hypoglycemia (which includes PBH and congenital HI). Avexitide is designed to bind to the GLP-1 receptor on pancreatic islet beta cells and inhibit the effect of GLP-1 to mitigate hypoglycemia by decreasing insulin secretion and stabilizing blood glucose levels. In PBH, excessive GLP-1 can lead to the hypersecretion of insulin and subsequent debilitating hypoglycemic events. In two Phase 2 PBH clinical trials, avexitide demonstrated highly statistically significant reductions in hypoglycemic events. These events can lead to autonomic and neuroglycopenic symptoms that can have a devastating impact on daily living.

About Post-Bariatric Hypoglycemia (PBH)

Post-bariatric hypoglycemia (PBH) is a condition that affects approximately 8% of people in the U.S., or approximately 160,000 people, who have undergone the two most common types of bariatric surgery, which include sleeve gastrectomy and Roux-en-Y gastric bypass (RYGB). PBH is thought to be caused by an excessive glucagon-like peptide-1 (GLP-1) response leading to hypoglycemia and impaired quality of life. PBH can cause debilitating hypoglycemic events associated with inadequate supply of glucose to the brain, known as neuroglycopenia. Clinical manifestations can include impaired cognition, loss of consciousness, and seizures. PBH is also associated with a high degree of disability that can result in major disruptions to independent living. There are no approved therapies for PBH.

About the LUCIDITY Trial

LUCIDITY (NCT06747468) is an approximately 75-participant, multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of avexitide in participants with PBH following Roux-en-Y gastric bypass (RYGB) surgery. The Phase 3 trial will be conducted at 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 trial includes an up to six-week screening period, including a three-week run-in period, and a 16-week double-blind treatment period. Participants who complete the double-blind period will be eligible to enter an open-label extension (OLE) period with a duration of 32 weeks. The primary efficacy objective of LUCIDITY will evaluate the FDA-agreed upon primary outcome of reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16. Safety and tolerability will also be evaluated.

About Amylyx Pharmaceuticals

At Amylyx, our mission is to usher in a new era of treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are currently focused on three investigational therapies across several neurodegenerative and endocrine diseases in which we believe they can make the greatest impact. For more information, visit amylyx.com and follow us on LinkedIn and X. For investors, please visit investors.amylyx.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, Amylyx’ expectations regarding: the potential of avexitide as a treatment for PBH; expectations regarding the timing for recruitment completion and topline data readout of the Phase 3 LUCIDITY trial of avexitide in PBH; and expectations regarding timing for potential commercialization of avexitide. Any forward-looking statements in this press release and related comments in the Company's earnings conference call are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Amylyx’ program development activities; Amylyx’ ability to execute on its regulatory development plans and expectations regarding the timing of results from its planned data announcements and initiation of clinical studies; the risk that early-stage results may not reflect later-stage results; Amylyx’ ability to fund operations, and the impact that global macroeconomic uncertainty, geopolitical instability, and public health events will have on Amylyx’ operations, as well as the risks and uncertainties set forth in Amylyx’ United States Securities and Exchange Commission (SEC) filings, including Amylyx’ Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent filings with the SEC. All forward-looking statements contained in this press release and related comments in our earnings conference call speak only as of the date on which they were made. Amylyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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