GeNeuro SA announced the GNC-501 clinical trial is a Phase 2 study in patients suffering from post-COVID-19 neuropsychiatric diseases, testing temelimab against placebo. The study enrolled over 200 patients in Switzerland, Spain and Italy who had tested positive for HERV-W ENV. The top-line results from this study show that treated patients had no clinically meaningful improvement compared to placebo on the primary endpoint measuring the improvement of fatigue with the PROMIS SF7a test.

The majority of secondary endpoints did not show an effect either. The treatment was very well tolerated and safe, consistent with previous clinical trials in other indications. Preliminary analyses suggest that shorter disease duration at time of inclusion, as well as the evolution of the underlying HERV-W ENV status, may have an impact on the efficacy outcome measures.

The Company will continue to analyze complete results once they become available, including additional biomarkers. GeNeuro thanks all the study participants, the investigators and all other site personnel for their commitment that made this novel study possible. The learnings from this study will certainly advance the knowledge of this new disease affecting millions of persons worldwide.