Chicago, Illinois, September 1, 2026
Xentria, Inc., a clinical-stage biotherapeutics company, has announced its next-stage clinical development plan for XTMAB-16, an investigational anti-tumor necrosis factor alpha (TNFα) monoclonal antibody being developed for pulmonary sarcoidosis. The company’s plans follow an end-of-phase meeting with the U.S. Food and Drug Administration (FDA), during which the agency provided feedback on the proposed primary efficacy endpoint and overall design of the next-stage clinical study. Xentria plans to incorporate the FDA’s recommendations into an amendment to the ongoing XTMAB-16-201 protocol, with enrollment in the planned XAtlas study expected to begin in the fourth quarter of 2026.
FDA Feedback Shapes XAtlas Clinical Trial Design
Under the proposed amended design, the XAtlas study will evaluate XTMAB-16 at a dose of 4 mg/kg administered every four weeks (Q4W) in a longer-term efficacy study. Planned enrollment is expected to increase substantially from 62 patients to up to 200 patients, while the study duration will be extended to 52 weeks. The proposed primary efficacy endpoint is change from baseline in forced vital capacity (FVC), a key measure of lung function that can help assess the impact of pulmonary sarcoidosis on respiratory capacity. Additional assessments are expected to evaluate disease control through the occurrence and timing of sarcoidosis worsening events, patient-reported respiratory outcomes and corticosteroid use. The FDA feedback represents an important regulatory milestone for Xentria as the company transitions XTMAB-16 toward a more comprehensive efficacy evaluation. No anti-TNFα therapy is currently approved by the FDA specifically for sarcoidosis, leaving an important unmet therapeutic need for patients whose disease can progress despite existing treatment approaches.
Anti-TNFα Approach Targets Sarcoidosis Inflammation
Exploratory analyses from Part A identified numerical trends favoring XTMAB-16 over placebo in areas including corticosteroid tapering, preservation of lung function and selected patient-reported outcomes. Xentria noted that these findings were exploratory and that the Part A study was not designed to establish efficacy for these measures. XTMAB-16 is a chimeric human-murine anti-TNFα monoclonal antibody designed to block TNFα, a pro-inflammatory cytokine involved in immune responses and implicated in the formation of granulomas associated with sarcoidosis. Pulmonary involvement occurs in more than 90% of people with sarcoidosis, and persistent inflammation can contribute to lung scarring, fibrosis and progressive respiratory impairment. By targeting TNFα, XTMAB-16 is intended to interfere with an inflammatory pathway that may contribute to granuloma formation and disease progression. The investigational therapy received FDA Orphan Drug Designation in November 2020, and Xentria completed a Phase 1 study in healthy volunteers in 2022. With FDA feedback now incorporated into its proposed next-stage development strategy, the company is preparing operational activities for XAtlas enrollment in the fourth quarter of 2026, marking the next significant step in the clinical evaluation of XTMAB-16 for pulmonary sarcoidosis.
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Source: Xentria press release
