Xentria's XTMAB-16 Receives Orphan Drug Designation from European Medicines Agency as First Patient Is Enrolled in Study
CHICAGO, IL November 15 2023: Xentria, Inc., a clinical-stage biotherapeutics company focused on developing therapeutics to address unmet clinical needs, today announced that its lead candidate, XTMAB-16, has been granted Orphan Drug Designation by the European Medicines Agency (EMA). The company is also announcing that the first US patient has been enrolled in its global study to evaluate XTMAB-16 as treatment for the rare disease sarcoidosis.
Xentria is developing XTMAB-16, an anti-TNFα monoclonal antibody which is being tested in a Phase 1b/2a clinical trial for its ability to potentially help patients with pulmonary sarcoidosis, a chronic, multisystem inflammatory disorder. XTMAB-16 is positioned as one of a few therapeutics specifically developed for and indicated for treatment of pulmonary sarcoidosis in contrast to symptomatic steroid treatment, which is the current standard of care.
Orphan Drug is a status assigned by the EMA to a medicine intended for treatment, prevention, or diagnosis of a disease that is life-threatening or chronically debilitating. The medicine must fulfill certain criteria to receive designation as an orphan medicine, including the potential to bring health benefits compared to existing treatments. XTMAB-16 previously received Orphan Drug Designation in the US from the Food and Drug Administration (FDA) in November 2020.
Tom Shea, President of Xentria said: “Receiving designation of Orphan Drug 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.”
“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”.
Lead study Principal Investigator (PI), Dr. Ogugua Obi added: “The development of XTMAB-16 is continuing to gain recognition globally. The first patient being enrolled onto the study by Dr. Peter Sporn at Northwestern Memorial Hospital will add to the breadth of data that will explore the potential of XTMAB-16 in treating sarcoidosis. The resulting data will include clinical safety data, in vitro results in a granuloma model, and novel biosimulations - all of which will play a vital part in the pathway to bring this drug to the market in both the US and Europe.
Xentria is dedicated to advancing challenging drug development, where greater levels of collaboration and partnership are demanded. Xentria will continue to build upon Phase 1 results, compelling investigative findings and ongoing biosimulation as trial data emerges. The team remains dedicated to support those developing drugs with challenging profiles to support their clinical development on the path to commercial launch.
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.
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.
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.
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