Pharma Focus Europe

Xentria's XTMAB-16 Secures Orphan Drug Designation from European Medicines Agency as Initial Patient Enlists in Trial

Thursday, November 16, 2023

Xentria, Inc., a clinical-stage biopharmaceutical company dedicated to addressing unmet clinical needs, has revealed that the European Medicines Agency (EMA) has granted Orphan Drug Designation to its primary candidate, XTMAB-16. Simultaneously, the company has announced the enrollment of the inaugural US patient in its global study assessing XTMAB-16 as a treatment for the rare disease sarcoidosis.

XTMAB-16, an anti-TNFα monoclonal antibody, is currently undergoing a Phase 1b/2a clinical trial to assess its potential in assisting patients with pulmonary sarcoidosis, a chronic inflammatory disorder impacting multiple systems. Unlike the current standard of care, which involves symptomatic steroid treatment, XTMAB-16 is designed as a therapeutic specifically developed for the treatment of pulmonary sarcoidosis.

Orphan Drug Designation is granted by the EMA to medicines intended for the treatment, prevention, or diagnosis of life-threatening or chronically debilitating diseases. XTMAB-16 had previously received Orphan Drug Designation in the US from the FDA in November 2020.

Xentria, remarked, "Receiving Orphan Drug designation from the EMA in the EU, in addition to the US, for our lead candidate XTMAB-16 further highlights the real need for ongoing drug development in rarer conditions such as sarcoidosis."

He added, "This designation further validates the potential of XTMAB-16 to fill the existing treatment gap in pulmonary sarcoidosis across the world. We have now enrolled our first patient into the study and believe the potential for this treatment could make a big difference for those suffering from the disease."

XTMAB-16's development, and the first patient enrollment marks a significant step in exploring its potential in treating sarcoidosis.

Sarcoidosis is a chronic inflammatory disorder characterized by the formation of granulomas in one or more organs. Pulmonary sarcoidosis, affecting over 90% of patients, can lead to chronic, progressive disease and potentially result in lung failure and death if left untreated.

XTMAB-16, a chimeric human-murine anti-TNFα monoclonal antibody, is designed to disrupt an inflammatory pathway and slow granuloma formation in pulmonary sarcoidosis. The ongoing Phase 1 clinical trial has shown promising results, and Xentria remains committed to advancing challenging drug development and supporting the clinical development of XTMAB-16 on the path to commercial launch.



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