Evergreen Therapeutics has announced that patient enrollment has been completed for the Phase II clinical trial of EG‑501, its AI‑enabled drug candidate for cognitive impairment associated with neuropsychiatric systemic lupus erythematosus (NPSLE). The trial is being conducted in the United States.
EG‑501 is the first candidate worldwide to enter Phase II development specifically for NPSLE‑related cognitive impairment. The Phase II study is a multicenter, randomized, double‑blind, placebo‑controlled trial being conducted at three U.S. academic centers. The study employs a dose‑escalation design and will evaluate safety, tolerability and efficacy across multiple dimensions, including the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and adverse event monitoring. The trial aims to address the significant global unmet need for targeted therapies for lupus‑related cognitive impairment, with key results expected to be reported according to the planned schedule.
As one of Evergreen’s core pipelines assets, the EG-501 program was developed using company’s in‑house AI platform. The program originated from AI‑driven modeling and innovatively applied PheWAS analyses and machine‑learning algorithms to explore associations between the drug target and disease phenotypes. By leveraging large, high‑quality datasets from leading academic medical centers, the platform performed enable precise feature selection and identified 12 target‑related disease phenotypes. These findings were integrated with assessments of market needs and commercial potential, leading to the prioritization of NPSLE‑related cognitive impairment as the indication for Phase II development. It completes a closed-loop from data analysis to clinical direction.