PHILADELPHIA, PA – December XX, 2025 – Alveus Therapeutics, Inc. (“Alveus”), a clinical-stage biotechnology company pioneering next-generation obesity and metabolic disease therapies, today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for ALV-100, its lead clinical asset for the treatment of obesity.
ALV-100 is a bifunctional GIPR antagonist and GLP-1R agonist fusion protein designed to deliver a potent and durable weight loss and weight maintenance therapy. The IND submission marks a critical milestone in Alveus’s mission to address the significant unmet needs that remain in this population.
“Current therapies have demonstrated good efficacy in inducing weight loss, but the real challenge facing patients and clinicians is keeping the weight off,” said Raj Kannan, Chief Executive Officer of Alveus Therapeutics. “ALV-100 is designed to address this fundamental need. This IND submission represents the first of multiple value-driving catalysts we expect to deliver over the next 18 months, as we advance toward our goal of a Phase 3-ready asset in the second half of 2027.”
Real-world evidence increasingly shows that many patients struggle to maintain weight loss achieved with current GLP-1 therapies, particularly when treatment is interrupted or discontinued due to cost, side effects, or injection fatigue. ALV-100’s unique profile, backed by human genetics and clinical validation, is purpose-built to address these challenges:
“Alveus is less than two years old, yet we’re executing with the speed and precision that comes from a team with a proven track record of bringing metabolic drugs from discovery to clinical proof of concept, said Jacob Jeppesen, Chief Scientific Officer and Head of R&D. “We’re not just developing another weight loss drug, we’re leading a solution for keeping weight off.”
In addition, Alveus continues to advance their discovery pipeline, with its highly selective amylin agonist, entering IND-enabling studies this month.
Earlier this month, Alveus raised $150 million in a Series A financing co-led by Andera Partners and New Rhein Healthcare Investors, with participation from Omega Funds, Sanofi, Avego Capital, and additional investors. Led by CEO Raj Kannan, former CEO of i-Mab, Aerie Pharmaceuticals, and Chiasma, Alveus brings together experts from across obesity and metabolism drug development, including leadership from Novo Nordisk, Eli Lilly, Regeneron, and other leading organizations.
Alveus Therapeutics, Inc. is a clinical-stage biotechnology company pioneering next-generation obesity and metabolic disease therapies. The company is developing a pipeline designed to address unmet needs in sustainable weight loss and long-term weight maintenance, including ALV-100, a bifunctional GLP-1R agonist and GIPR antagonist fusion protein, and a portfolio of amylin-based therapies designed to enhance the quality of weight loss. Alveus holds global rights outside Greater China, acquired from Gmax Biopharm International Limited in 2024.
For more information, visit www.alveustx.com
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