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Xentria Announces Peer Reviewed Publication of Biosimulation Model in Frontiers in Pharmacology Journal
Model Helps Estimate Dose of XTMAB-16 in Advance of Clinical Trial in Patients with Pulmonary Sarcoidosis CHICAGO--(BUSINESS WIRE)-- Xentria, Inc., a biotech
About this update from Certara, Inc.
[{"type":"text","content":"\nModel Helps Estimate Dose of XTMAB-16 in Advance of Clinical Trial in Patients with Pulmonary Sarcoidosis\n\n CHICAGO--(BUSINESS WIRE)--\nXentria, Inc., a biotech company focused on developing treatments to address unmet clinical needs, today announced the peer reviewed publication in Frontiers in Pharmacology of a biosimulation model for XTMAB-16, its sarcoidosis treatment candidate. The publication, entitled “Leveraging in vitro and pharmacokinetic models to support bench to bedside investigation of XTMAB-16 as a novel pulmonary sarcoidosis treatment” can be found here.\n\nPartnering with Certara, Inc., (Nasdaq: CERT) a global leader in biosimulation, and lead investigator Elliott D. Crouser, M.D., Professor of Internal Medicine, Wexner Medical Center at The Ohio State University, Xentria used biosimulation to more accurately estimate a safe and effective dose for XTMAB-16 for its upcoming first in-patient clinical trial commencing early 2023.\n\n“Estimating safe and effective human doses of any drug is an important part of the overall clinical development process but selecting the starting dose in humans is extremely complex - it must be low enough to be safe but high enough to avoid excessive dose escalations,” says Elliot Offman, Ph.D., Vice President at Certara. “By leveraging modeling technology that uses non-clinical data combined with XTMAB-16’s Phase 1 findings, we were able to work with Dr. Crouser to support clinical dosing regimens in the initial trial in the sarcoidosis patient population.”\n\nXTMAB-16, which received orphan drug designation in November 2020, is being developed as a novel biologic with the proposed indication of treating sarcoidosis, a rare and debilitating condition that causes small patches of swollen tissue, called granulomas, to develop in organs of the body, including the skin, eyes, heart, and central nervous system. The multi-system condition has widely variable disease manifestations and outcomes which require targeted therapies that help prevent disease progression.\n\nXTMAB-16 is a novel chimeric anti-tumor necrosis factor α antibody that was shown to be well tolerated in healthy volunteers and was further shown to suppress in vitro sarcoidosis granuloma formation in a dose-dependent manner.\n\nIn a Phase 1 clinical study, single escalating doses of XTMAB-16 were administered to healthy...