PHILADELPHIA, PA & COPENHAGEN, Denmark — Alveus Therapeutics said the U.S. Food and Drug Administration has cleared its Investigational New Drug application for ALV-100, allowing the company to begin clinical testing of its lead therapy for chronic weight management in adults with obesity.
The clearance enables a Phase 1b clinical study, and the company said the first patient has already been dosed, marking a rapid transition from financing to clinical execution.
ALV-100 is a bifunctional fusion protein that combines glucose-dependent insulinotropic polypeptide receptor antagonism with glucagon-like peptide-1 receptor agonism. The approach is designed to promote sustained weight loss while improving tolerability and long-term adherence, a growing focus as weight-management therapies move from short-term results toward chronic use.
The Phase 1b trial is a randomized, double-blind, placebo-controlled, dose-escalation study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneously administered ALV-100. About 180 adults with overweight or obesity will be enrolled across multiple U.S. clinical sites, including participants with and without type 2 diabetes.
Chief Executive Officer Raj Kannan said the IND clearance and initial dosing represent key milestones following the company’s recent Series A financing, positioning ALV-100 for accelerated clinical development. He said the therapy was designed to support long-term weight maintenance with a simpler treatment approach suited to real-world use.
Alveus said its development strategy emphasizes dosing regimens intended to align with patient needs over time, aiming to balance efficacy with convenience and tolerability as treatment durations extend.
Chief Scientific Officer and Head of Research and Development Jacob Jeppesen said the company believes combining GIP receptor antagonism with GLP-1 receptor agonism can improve the long-term treatment experience for patients managing obesity. He said the Phase 1b study represents the first of several planned milestones as Alveus works toward Phase 3 readiness in the second half of 2027.
The FDA clearance places Alveus among a growing field of biopharmaceutical companies seeking next-generation obesity treatments as demand for durable, scalable weight-management solutions continues to rise.
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