ATS 2025
A Phase 2, Randomized, Double-blind Clinical Trial Investigating the Safety and Efficacy of Intravenous XTMAB-16 Versus Placebo in Patients With Pulmonary Sarcoidosis
Abstract: P556
Session: Repair My Broken Lungs
Poster available: Monday, May 19, 2025, 9:15 AM – 4:15 PM
Xentria presents an update on its lead investigational therapy, XTMAB-16, at the 2025 ATS International Conference. In a featured poster presentation, Xentria provided an overview of the first-in-patient (FIP) trial design and progress on the ongoing clinical evaluation of XTMAB-16 since passing enrollment targets in Q1 2025.
Key points from the poster include:
- XTMAB-16 is a chimeric monoclonal antibody targeting tumor necrosis factor-alpha (TNFα), a proinflammatory cytokine involved in sarcoidosis
- Advanced translational modeling guides clinical strategy: Implementation of human translational framework using population pharmacokinetic (popPK) modeling predicted therapeutically relevant lung tissue drug concentrations for FIP dose-ranging portion of the XTMAB16 Study
- Model-informed dosing for seamless trial design: PopPK modeling informed the dosing strategy to be implemented in this seamless Phase 1b/2 study and support a more precise and efficient study design
- Part A dose-ranging results will be used to further refine the popPK modeling to inform doses for future studies of XTMAB-16
Conclusions from the poster include:
- Implementation of a model-informed dosing strategy is intended for rapid dose selection. This model may serve as a framework for future trials in sarcoidosis.
- The outcomes emphasize that strategically structured clinical trials are essential to generate robust, generalizable evidence in the rare disease setting.
- The XTMAB16 Study remains ongoing globally.
About XTMAB-16
XTMAB-16 is novel biologic developed by Xentria to address the unmet medical need for patients with sarcoidosis, a rare inflammatory disease that affects multiple organs in the body. XTMAB-16 is a monoclonal antibody designed to suppress the inflammatory pathways promotion of sarcoidosis granuloma formation. No TNF-α inhibitor is currently approved for the treatment of sarcoidosis. Extensive analyses have been conducted to demonstrate the physio-chemical properties and pharmacology of XTMAB-16 as a TNFα inhibitor. The clinical study of this effect remains ongoing.
XTMAB-16 is not available for sale in the United States. Future commercial use will depend on successful clinical trials and regulatory review and approval.
About Sarcoidosis
Sarcoidosis is a chronic, multisystem inflammatory disorder of unknown etiology that is characterized by the presence of noncaseating epithelioid granulomas, accompanied by infiltration of mononuclear cells and destruction of microarchitecture. The disease can affect the skin, eyes, heart, and central nervous system, and >90% of cases involve the lungs. While medications for systemic organ involvement often control this disease, some patients fail to respond to initial treatments and require additional targeted therapy, resulting in significant costs and treatment burdens. This disease presents a significant unmet medical need and a very important area of research and development for Xentria.
American Thoracic Society (ATS)
International Conference 2025
Date: May 16-21, 2025
Location: San Francisco
Presentation: Abstract poster