Prometheus Biosciences Inc. (Nasdaq: RXDX), a biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, today announced it has enrolled its first patient in the ATHENA-SSc-ILD trial, a placebo-controlled and statistically powered Phase 2 study of PRA023 in SSc-ILD. The Company announced in January 2021 that PRA023 received Fast Track Designation from the US Food and Drug Administration for the treatment of SSc-ILD.
“PRA023, our anti-TL1A antibody, has shown the potential to be a differentiated, best-in-class precision therapy for multiple immune-mediated diseases and we now have three Phase 2 trials underway, demonstrating PRA023’s pipeline-in-a-product opportunity,” said Mark McKenna, Chairman and CEO of Prometheus. “Prometheus’ initiation of ATHENA-SSc-ILD exemplifies our team’s strong execution, marking the first indication of PRA023 outside of IBD.”
Systemic Sclerosis (SSc) is a rare autoimmune disorder characterized by progressive fibrosis of the skin and internal organs thought to result from inflammation and chronic immune activation. Lung involvement (SSc-ILD) is the leading cause of morbidity and mortality for individuals with the disorder. SSc-ILD has been largely irreversible with current therapeutic strategies focused on slowing progression of the disorder.
“We believe PRA023’s dual anti-fibrotic and anti-inflammatory mechanism of action is well-suited to address the underlying disease pathophysiology of SSc-ILD, where no disease modifying therapies currently exist,” said Allison Luo, M.D., Chief Medical Officer of Prometheus. “The initiation of the ATHENA-SSc-ILD study is an important milestone for the Company and for patients who are suffering from this rare disorder.”
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