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,” says 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.

About the trial in Thyroid Eye Disease

The 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.
Lu AG22515 is a therapeutic candidate being developed under a licensing and collaboration agreement between Lundbeck and AprilBio. 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