ORJ-001

ORJ-001 is a selective $\beta$1 integrin agonist peptide being developed by Oorja Bio and NIBEC for the treatment of idiopathic pulmonary fibrosis (IPF). It selectively binds to the primed configuration of $\beta$1 integrin in damaged tissues, a state induced by cytokines and growth factors, while showing negligible binding to normal tissues. By activating $\beta$1 integrin, ORJ-001 aims to promote the regeneration of the alveolar epithelium and reduce established lung fibrosis. Preclinical studies in bleomycin-induced models demonstrated significant reduction in fibrosis and repair of the alveolar epithelium. Phase 1 clinical trials in healthy volunteers have established its safety, tolerability, and pharmacokinetic profile, supporting its progression into Phase 2 development. Tenascin-C (TN-C) has been identified as a potential biomarker for monitoring treatment response.