Amylyx Pharma to present topline data from Phase 3 LUCIDITY trial of avexitide

For best results when printing this announcement, please click on link below: Amylyx Pharmaceuticals to Present Topline Data from Phase 3 LUCIDITY Clinical Trial of Avexitide in Post-Bariatric Hypoglycemia at ObesityWeek(®) 2026 Annual Meeting Late-breaking oral presentation to feature Phase 3 topline data highlighting avexitide’s efficacy and safety Amylyx Pharmaceuticals, Inc. C.

The first late-breaking oral presentation will feature topline results from the Phase 3 LUCIDITY clinical trial of avexitide, an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist, in participants with post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass (RYGB) surgery. This follows the Company’s announcement of positive topline results from LUCIDITY in August 2026. PBH is a chronic metabolic condition driven by an exaggerated GLP-1 response, primarily after food intake, leading to persistent, recurrent, and often debilitating rapid drops in blood glucose, known as hypoglycemia.

Avexitide is a competitive GLP-1 receptor antagonist designed to inhibit the exaggerated GLP-1-driven insulin response, reducing inappropriate insulin secretion and stabilizing blood glucose levels. PBH is associated with morbidity and impaired quality of life, and there is no FDA-approved therapy. The second presentation highlights a machine learning-based approach to identifying individuals with PBH in real-world claims data. The study aims to provide insights into real world characteristics, diagnosis, and healthcare burden of people with PBH.

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ET Location: Gaylord National Resort & Convention Center, Exhibit Hall BCD The presentations will be made available on the “Presentations ” tab of the Amylyx website in accordance with ObesityWeek’s embargo policy. About Avexitide Avexitide is an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist that has been evaluated in six clinical trials for post-bariatric hypoglycemia (PBH) and has also been studied in congenital hyperinsulinism (HI). 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). In PBH, an exaggerated GLP-1 response leads to excessive insulin secretion, resulting in recurrent hypoglycemic events.

Avexitide is a competitive GLP-1 receptor antagonist designed to bind to the GLP-1 receptor on pancreatic islet beta cells and inhibit the exaggerated GLP-1-driven insulin response characteristic of PBH, reducing inappropriate insulin secretion and stabilizing blood glucose levels. In two Phase 2 and the Phase 3 LUCIDITY clinical trials in PBH, avexitide demonstrated highly statistically significant reductions in hypoglycemic events. S. ).

PBH is thought to be driven by an exaggerated glucagon-like peptide-1 (GLP-1) response, primarily in response to food intake, leading to persistent, recurrent, and often debilitating rapid drops in blood glucose, known as hypoglycemia. The American Diabetes Association (ADA) recognizes hypoglycemia as a potential medical emergency because low blood glucose levels can compromise the body’s ability to maintain essential physiologic processes. In addition, hypoglycemia in the context of PBH may manifest as neuroglycopenia — an inadequate supply of glucose to the brain — which can cause confusion, cognitive dysfunction, loss of consciousness, and seizures.

PBH can be associated with substantial disability, compromising safety, disrupting independent living, and affecting nutritional status and overall quality of life. Despite the substantial burden, there are currently no FDA-approved therapies for PBH. About the LUCIDITY Trial LUCIDITY (NCT06747468 ) is a 78-participant, multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of avexitide in participants with PBH following RYGB surgery. S.

Participants were 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, a 16-week double-blind treatment period, and a 32-week open-label extension (OLE) period. The primary efficacy objective of LUCIDITY was to 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 were also 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 four investigational therapies across several endocrine conditions and neurodegenerative diseases in which we believe can make the greatest impact. com and follow us on LinkedIn and X ( ).

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’s expectations regarding: the therapeutic potential and safety of avexitide as a treatment for PBH; the potential benefits of regulatory designations held with the FDA; and the plan to present data from LUCIDITY at an upcoming medical meeting. Any forward-looking statements in this press release 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’s program development activities; Amylyx’s 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’s ability to fund operations, and the impact that global macroeconomic uncertainty, geopolitical instability, and public health events will have on Amylyx’s operations, as well as the risks and uncertainties set forth in Amylyx’s United States Securities and Exchange Commission (SEC) filings, including Amylyx’s Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent filings with the SEC.

All forward-looking statements contained in this press release 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. com) Investors Courtney O’Leary Amylyx Pharmaceuticals, Inc. com)