GeNeuro Announces Last Patient Last Visit in its Post-COVID Trial and Confirms Top-Line Results by End of June 2024

Regulatory News:

GeNeuro (Euronext Paris: CH0308403085 – GNRO), a biopharmaceutical company developing therapies for patients with neurodegenerative and autoimmune diseases such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) and Post-Acute Sequelae of COVID-19 (PASC, long-COVID or post-COVID), today announced that the last patient enrolled in the GNC-501 trial of temelimab against post-COVID has now completed the study.

The trial “Temelimab as a Disease Modifying Therapy in Patients With Neuropsychiatric Symptoms in Post-COVID 19 or PASC Syndrome” (GNC-501) is a randomized, placebo-controlled, biomarker-based, Phase 2 clinical trial assessing the safety and the efficacy of the treatment with temelimab, a monoclonal antibody neutralizing the pathogenic HERV-W ENV protein. The trial has recruited 203 patients across 14 clinical centres in Switzerland, Spain and Italy.

All patients included in the study were tested positive for the expression of the HERV W-ENV protein, which is a key factor in the activation of the innate immune response and is suspected to have a major role in the persistence of inflammation and in the broad spectrum of neurological symptoms affecting patients with post-COVID. Over 1/3 of the patients screened had detectable W-ENV protein expression in blood, suggesting that temelimab could become a relevant treatment option for a large subset of this underserved patient population.

All enrolled patients received 6 intravenous infusions of temelimab or placebo (1 to 1 randomization) over 24 weeks. The clinical endpoints will assess the efficacy and the safety of the treatment with temelimab on the improvement in fatigue and cognitive impairment measures.

“With this last visit of the last patient, we have reached a key step towards the finalization of the GNC-501 study exploring a potential precision-medicine based treatment option for subjects suffering from post-COVID,” said Dr. Anke Post, Chief Medical Officer of GeNeuro. “We thank all patients who have agreed to participate in this study, the largest of its kind up to date, and hope that the results at the end of June will confirm the potential of temelimab to relieve persistent symptoms such as fatigue and to impact the disease burden.”