Xentria获FDA反馈后推进XTMAB-16肺结节病后续临床方案

XTMAB-16-201 Part A pharmacokinetic exposure, target-coverage, immunogenicity, safety and feasibility findings provided an integrated basis for further clinical evaluation and informed the proposed next-stage development plan
Proposed amendment to XTMAB-16-201 Part B will evaluate 4mg/kg every four weeks in a 52-week efficacy study called the XAtlas study
CHICAGO, Sept. 1, 2026 /PRNewswire/ -- Xentria, Inc., a clinical-stage biotherapeutics company, today announced its proposed next-stage clinical development plan for XTMAB-16, an investigational anti-tumor necrosis factor alpha, being evaluated in pulmonary sarcoidosis, a rare disease for which no anti-TNFα is currently approved by the U.S. Food and Drug Administration.
Following an end-of-phase meeting, the FDA provided feedback on Xentria's proposed primary efficacy endpoint and overall trial design for Part B (XAtlas study). Xentria plans to incorporate that feedback into an amendment to the ongoing XTMAB-16-201 protocol.
Under the proposed design, planned enrollment for XAtlas would increase from 62 to up to 200 patients, and the study duration would extend to 52 weeks.
Xentria plans to evaluate XTMAB-16 at a dose of 4mg/kg administered every four weeks (Q4W). The proposed primary efficacy endpoint is change from baseline in forced vital capacity (FVC) with additional assessments expected to characterize disease control through measures, including the occurrence and timing of sarcoidosis worsening events, patient-reported reported respiratory outcomes and corticosteroid use.
"Xentria is dedicated to pulmonary sarcoidosis," said Tom Matthews, Senior Vice President of Clinical Development at Xentria. "We are preparing operational activities with XAtlas enrollment planned in the fourth quarter of 2026."
Part A Study and Safety Highlights:
XTMAB-16-201 Part A was a randomized, placebo-controlled, double-blind multiple ascending dose (MAD) trial in 39 adults with pulmonary sarcoidosis across the United States, European Union, and United Kingdom (38 completed). Patients received 2 mg/kg or 4 mg/kg administered every 2 or 4 weeks (Q2W or Q4W) during a 12-week period.
Part A was designed to assess safety, tolerability, pharmacokinetics, immunogenicity and preliminary clinical activity and to inform dose selection for further evaluation.
Safety Profile:
XTMAB-16 was well tolerated with no unexpected treatment-emergent adverse events and no dose-limiting toxicities (DLTs) identified. In addition, no deaths, serious adverse events (SAEs) related to study intervention, opportunistic infections, lymphomas or hepatotoxicity were reported. Because of the study's limited sample size and duration, these observations do not establish the overall safety profile of XTMAB-16.
Clinical and Biomarker Trends:
Exploratory analysis identified numerical trends favoring XTMAB-16 versus placebo in corticosteroid tapering, lung function preservation and select patient-reported outcomes.
These exploratory findings are intended to inform the continued clinical development of XTMAB-16 as the study 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 appreciate the FDA's feedback on our proposed development plan," said Tom Shea, CEO of Xentria. "We plan to incorporate that feedback into the XAtlas protocol and move one step closer progressing XTMAB-16 in a disease of great unmet need."
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.
To learn more about Xentria visit www.xentria.com.
SOURCE Xentria, Inc.