Prometheus Biosciences Initiates Third Phase 2 Study of PRA023 for Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)

– First therapeutic candidate for the treatment of SSc-ILD targeting both key fibrotic and inflammatory pathways –

– ATHENA-SSc-ILD Phase 2 topline results expected first-half 2024 –

– FDA has granted Fast Track Designation for PRA023 for the treatment of SSc-ILD –

Excerpt from the Press Release:

SAN DIEGO, March 30, 2022 (GLOBE NEWSWIRE) — 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.”  

About the ATHENA-SSc-ILD Study

ATHENA-SSc-ILD is a placebo-controlled Phase 2 trial of PRA023 in SSc-ILD, enrolling approximately 100 patients who will be randomized 1:1 to either the active or placebo arm. The primary endpoint of the trial will be the change in forced vital capacity (FVC) at 50 weeks. Secondary endpoints will be change in quantitative interstitial lung disease by centrally-read high-resolution computed tomography (HRCT) and improvement in the American College of Rheumatology Combined Response Index in Diffuse SSc (ACR-CRISS) score.

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