Chicago, Illinois – Xentria, a clinical-stage biopharmaceutical company advancing therapies for rare and serious diseases, today announced the successful completion of enrollment in the therapeutic dose-ranging phase of its global XTMAB16 Study in pulmonary sarcoidosis, an immune-mediated inflammatory disorder with few available treatment options. The dose-ranging study successfully enrolled 39 patients across 17 centers in 4 countries, surpassing initial enrollment targets—a testament to both the strong interest in advancing pulmonary sarcoidosis research and the momentum behind XTMAB16’s clinical development. The Data Safety Monitoring Committee (DSMC) will carefully evaluate dose-response relationships between the active dose and placebo groups to determine the optimal dose for further investigation. This critical milestone will inform the next phase of investigation, with screening anticipated to begin in Fall 2025.
“This marks a significant step forward for the sarcoidosis community, bringing us closer to innovative treatment options for this complex disease,” said Dr. Keith Robinson, Medical Lead & Scientific Advisor. “The progress of the XTMAB16 Study represents a critical advancement in understanding and addressing pulmonary sarcoidosis. We are encouraged by the momentum of this research and look forward to the insights it will provide, with the potential to shape future treatment strategies and improve patient outcomes.”
In recognition of its scientific impact, the XTMAB16 Study has been selected for a thematic poster session at the 2025 American Thoracic Society (ATS) Conference. The study will be presented on Monday, May 19, highlighting key advancements in Xentria’s investigational monoclonal antibody therapy for pulmonary sarcoidosis.
Further demonstrating its commitment to translational medicine, Xentria will share progress in its XTMAB-16 program at the ATS Respiratory Innovation Summit, including novel translational efforts that integrate totality of evidence in drug development.
Continuing its commitment to scientific innovation and leadership, Xentria will join a panel at Certara’s upcoming ‘Certainty’ Symposium on Drug Development and Regulatory Strategy. The company’s session, “A Transformative Approach to Drug Development,” will highlight the strategic use of Model-Informed Drug Development (MIDD) in shaping clinical trial design. By leveraging MIDD, Xentria optimized dose determinations ahead of its first-in-patient trial, ensuring a data-driven approach to advancing its investigational therapy. The discussion will explore how integrating holistic data approaches can enhance drug development efficiency and improve patient outcomes.
“These milestones underscore our commitment to advancing transformative treatments for patients living with pulmonary sarcoidosis,” said Noopur Singh, Vice President of Marketing & Patient Affairs at Xentria. “We look forward to engaging with the scientific and medical communities at ATS and Certara’s ‘Certainty’ Symposium as we continue to drive innovation in rare disease research.”
About Sarcoidosis
Sarcoidosis is a chronic, multisystem inflammatory disorder of unknown etiology that is characterized by the formation of granulomas — clumps of inflammatory cells — in one or more organs in the body. Sarcoidosis affects people of all ages but most commonly affects young and middle-aged adults.
While sarcoidosis can occur in any organ, more than 90% of patients with sarcoidosis will have the lungs affected, which is called pulmonary sarcoidosis. Left undiagnosed or untreated, the condition of patients with pulmonary sarcoidosis could degenerate into a chronic, progressive disease. Chronic, unresolved lung inflammation may result in scarring (fibrosis) that permanently damages the lung tissue and can lead to lung failure and death. In this complicated cascade of pro-inflammatory cytokines, the enhanced expression of TNFα, a cytokine that plays a significant role in antigen-stimulated, cell-mediated immune responses, may promote the formation of harmful granulomas and fibrosis throughout the body in people with sarcoidosis.
About XTMAB-16
XTMAB-16 is a chimeric human-murine anti-TNFα monoclonal antibody being developed as a novel biologic product for the treatment of pulmonary sarcoidosis with or without extra pulmonary involvement. Based on its ability to block TNFα, XTMAB-16 may disrupt an inflammatory pathway and help slow granuloma formation. Through dedicated regulatory work and focus from Xentria’s team, XTMAB-16 was granted Orphan Drug Designation by the FDA for the New Drug Entity in November 2020. A Phase 1 clinical trial in healthy volunteers was completed in 2022. No TNFα 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.
About Xentria
Established in 2020, Xentria works across biopharmaceutics communities creating innovative and authentic collaborations and partnerships that advance challenging drug development. Xentria, derived from “centrality”, is dedicated to delivering customized approaches to ambitious drug innovation through meaningful patient engagement and effective partnerships. Headquartered in Chicago, Xentria is taking the lead to support surging life sciences initiatives for global audiences, while nurturing diversity, individualism, and sustainability.
Contact
contact@xentria.com