Xentria Expands XAtlas Study for XTMAB-16 in Pulmonary Sarcoidosis

Chicago, September 1, 2026, Xentria, Inc., a clinical-stage biotherapeutics company, has outlined its next steps for advancing XTMAB-16, an investigational anti-tumor necrosis factor alpha (TNFα) therapy for pulmonary sarcoidosis. The decision follows feedback from the U.S. Food and Drug Administration (FDA) during an end-of-phase meeting.

According to Xentria, the proposed next-stage development plan for XTMAB-16 includes a significant expansion of the XAtlas study, a 52-week efficacy trial. The study will evaluate XTMAB-16 at a dose of 4 mg/kg administered every four weeks (Q4W) and is expected to enroll up to 200 patients, up from the initial 62 participants. The primary efficacy endpoint will be the change from baseline in forced vital capacity (FVC), a measure of lung function. Additional assessments will include disease control through patient-reported respiratory outcomes and corticosteroid use.

"We are committed to advancing XTMAB-16 for the benefit of patients with pulmonary sarcoidosis," said Tom Matthews, Senior Vice President of Clinical Development at Xentria. "We are preparing the necessary operational activities with the XAtlas enrollment scheduled for the fourth quarter of 2026."

The XAtlas study will build on the findings from XTMAB-16-201 Part A, a randomized, placebo-controlled, double-blind multiple ascending dose (MAD) trial conducted in 39 adults with pulmonary sarcoidosis across the United States, European Union, and United Kingdom. The Part A trial, completed by 38 participants, aimed to assess safety, tolerability, pharmacokinetics, immunogenicity, and preliminary clinical activity. XTMAB-16 was well-tolerated, with no unexpected treatment-emergent adverse events or dose-limiting toxicities reported.

Exploratory analyses from the Part A study indicated numerical trends favoring XTMAB-16 in corticosteroid tapering, lung function preservation, and select patient-reported outcomes. These findings will inform the continued development of XTMAB-16, though the trial was not designed to establish efficacy for these outcomes. Topline results from Part A were presented by Ogi Obi, M.D., at the American Thoracic Society International Conference in May 2026.

"We are grateful for the FDA's feedback, which has helped us refine our development plan," said Tom Shea, CEO of Xentria. "We are now better prepared to move XTMAB-16 forward in a field with significant unmet needs."

Pulmonary sarcoidosis, a chronic inflammatory disorder, affects more than 90% of patients, impacting the lungs. The condition can lead to progressive lung damage and scarring, potentially resulting in lung failure. XTMAB-16, as a TNFα inhibitor, aims to disrupt the inflammatory pathway and help slow granuloma formation. The company has received Orphan Drug Designation for XTMAB-16 and is currently conducting clinical trials to further evaluate its efficacy.

Xentria, established in 2020, focuses on advancing innovative drug development through meaningful patient engagement and strategic partnerships. Headquartered in Chicago, the company is dedicated to supporting global life sciences initiatives while fostering diversity and sustainability.