Lundbeck initiates clinical trial in immunology for Lu AG22515 in Thyroid Eye Disease

H. Lundbeck A/S (Lundbeck) today announced taking one further step in developing treatments for indications in the neuroimmunology and neuroinflammatory space with the initiation of the first clinical trial of its CD40L blocker, Lu AG22515, in patients.

Lundbeck’s proof-of-concept (PoC) trial will evaluate the efficacy, safety, and tolerability of Lu AG22515 as a potential treatment for Thyroid Eye Disease, an autoimmune disease causing a debilitating, disfiguring, and potentially blinding periocular condition.

“We are excited to initiate our first project within neuroimmunology with this proof-of-concept phase Ib trial exploring the potential of Lu AG22515 in treating Thyroid Eye Disease, a condition that severely impacts patients’ health related quality of life,” said Johan Luthman, EVP, and Head of Research & Development at Lundbeck.

Blocking CD40L inhibits both B and T cell activations without direct clearance of B cell populations and holds strong promise in treating a wide range of autoimmune-related CNS disorders.

This new trial highlights Lundbeck’s commitment to advancing innovative treatments for patients with severe and rare conditions.

About the 20453A trial in Thyroid Eye Disease (NCT06557850)
The 20453A trial is an interventional, open-label, single-group, long-term follow-up trial to evaluate the effects of Lu AG22515 in adult men and women with moderate-to-severe thyroid eye disease. 19 patients are planned to be enrolled.

About Lu AG22515
Lu AG22515 is a therapeutic candidate being developed under a licensing and collaboration agreement between Lundbeck and AprilBio Co., LTD. It is a differentiated anti-CD40L blocker fusion-protein due to its anti-Serum Albumin Fab Associated (SAFA) technology providing high potency, extended half-life, and minimizing adverse effects. By targeting the CD40L pathway, which is involved in the activation of complex T-cell mediated autoimmune responses, Lu AG22515 may represent a novel approach in the treatment of TED and may have potential in a range of neuro-immunological diseases.

About Thyroid Eye Disease
Thyroid Eye Disease (TED) is an autoimmune disease caused by the activation of orbital fibroblasts by autoantibodies directed against thyroid receptors. It is a rare disease characterized by autoimmune-mediated local inflammation, leading to the expansion of muscles and fat tissues around the eyes.