The GNC-501 clinical trial is a phase 2 study in patients suffering from post-COVID-19 neuropsychiatric syndromes, testing temelimab against placebo. The study included more than 200 patients in Switzerland, Spain and Italy who tested positive for HERV-W ENV. The initial results of this study show that treated patients did not have a clinically significant improvement compared to placebo on the primary endpoint measuring improvement in fatigue with the PROMIS SF7a test. The majority of secondary endpoints also showed no effect. The treatment was very well tolerated and safe, as in previous clinical trials in other indications.
Preliminary analyses suggest that shorter disease duration at baseline, as well as changing underlying HERV-W ENV status, may impact efficacy measures. The Company will continue to analyze full results as they become available, including additional biomarkers.
GeNeuro thanks all study participants, investigators and all site personnel for their commitment which made this innovative study possible. The lessons learned from this study will certainly advance knowledge of this new disease which affects millions of people around the world.
GeNeuro’s board of directors took note of these results and decided to further reduce its operating costs and workforce in order to preserve cash flow while considering all strategic alternatives for the company. As a result, Swiss parent company GeNeuro SA officially terminated the employment contracts of 7 out of 9 employees, including those of all members of management. All employees and managers will work during their notice period, up to 6 months, to implement the strategy which will be defined by the board of directors in the coming days. An announcement detailing the strategic plan, including the implications for the French R&D subsidiary, will be made shortly thereafter. The Company will continue to seek ways to advance or monetize its pipeline assets for multiple sclerosis and amyotrophic lateral sclerosis, as well as its HERV platform, to generate value for all stakeholders.
Source and visual: GeNeuro
