Alveus Therapeutics Announces FDA Clearance of IND and First Patient Dosed in Phase 1b Trial of ALV-100 for Obesity

PHILADELPHIA, Pennsylvania and COPENHAGEN, Denmark – January 23, 2026 – Alveus Therapeutics, Inc. (“Alveus”), a clinical-stage biotechnology company developing next-generation therapies for obesity and metabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ALV-100, the company’s lead investigational therapy for chronic weight management, enabling initiation of a Phase 1b clinical study. The first patient was dosed last week. ALV-100 is a bifunctional glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonist / glucagon-like peptide-1 receptor (GLP-1R) agonist fusion protein designed to address long-term weight management and tolerability in adults with obesity. The Phase 1b study is a randomized, double-blind, placebo-controlled, dose-escalation trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneously administered ALV-100 in adults with overweight or obesity, with or without type 2 diabetes. Approximately 180 patients will be enrolled across multiple U.S. clinical sites. “Following the successful close of our Series A financing earlier this month, we moved quickly to advance ALV-100 into the clinic in the United States,” said Raj Kannan , Chief Executive Officer of Alveus. “ALV-100 was designed not only to drive robust weight loss but also to support long-term weight maintenance with a simpler treatment approach. This IND clearance and first patient dosing are critical steps toward building a robust Phase 3 program.” ALV-100 is being developed to support long-term weight management with a focus on convenience and tolerability. Alveus’ strategy is focused on evaluating dosing regimens that better match real-world patient needs over time. “We believe combining GIPR antagonism with GLP-1 receptor agonism can support long-term weight management with a better treatment experience,” said Jacob Jeppesen, PhD , Chief Scientific Officer and Head of R&D at Alveus. “This Phase 1b study is the first of several planned milestones as we move toward Phase 3 readiness in the second half of 2027.” About Alveus Therapeutics Alveus is a clinical-stage biotechnology company developing next-generation therapies for obesity and metabolic diseases, designed for sustained efficacy, improved tolerability, and reduced treatment burden. Alveus acquired global development and commercialization rights outside of greater China to ALV-100 from Gmax Biopharm International Limited in 2024. Alveus is headquartered in Philadelphia, PA, with research and development operations based in Copenhagen, Denmark. For more information, visit www.alveustx.com Investor & Media Contacts Alveus Therapeutics Media Sasha Damouni Ellis, Damouni Group LLC [email protected] Investors Victoria Igumnova, Meru Advisors LLC [email protected]

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