Leveraging Pharmacokinetic Modeling & Scientific Communications Expertise Advances Sarcoidosis Drug Program
Sarcoidosis is a complex, debilitating rare condition with few effective treatment options, especially for cases that are resistant to first-line therapies. This condition affects multiple organs- including the lungs- leading to persistent inflammation and non-caseating epithelioid granulomas. Unlike other types of granulomas, the distinct characteristics of sarcoidosis granulomas further complicates developing viable treatment strategies.
Xentria is a pioneering biopharmaceutical company focused on developing biologic and innovative drug therapies. Their investigational drug, XTMAB-16, is a novel chimeric anti-tumor necrosis factor alpha (TNFα) antibody that holds promise as a potential breakthrough treatment for pulmonary sarcoidosis.
Monte-Carlo simulations were conducted for dosage regimens of 2 and 4 mg/kg over a 16-week period, taking into account factors such as body weight and the presence of ADA. Prediction of pulmonary interstitial fluid XTMAB-16 concentrations were informed by published biodistribution coefficients. Simulations enabled visualization of the XTMAB-16 concentrations at or above the threshold of efficacy estimated from the non-clinical model of sarcoidosis. Optimal dosage levels of 2 and 4 mg/kg administered at specific intervals were determined as a result of the simulations and informed the ongoing clinical development of XTMAB-16 in the treatment of patients with sarcoidosis.
Furthermore, Certara’s medical communications and publications writing team collaborated with Xentria to transform the study’s findings into a well-crafted manuscript that was published in The Frontiers in Pharmacology. Certara’s expertise in publication planning and scientific writing ensured the manuscript’s accuracy, integrity, and adherence to rigorous standards, streamlining the publication process.