GeNeuro enrolls first patient in temelimab Phase 2 multiple sclerosis trial in collaboration with the Karolinska Institutet’s Academic Specialist Center (ASC).
The one-year single center trial is planned to enrol 40 patients whose disability progresses without relapses, the key unmet medical need in multiple sclerosis, as patients’ disability builds-up over time despite the use of effective anti-inflammatory drugs. The study will assess safety, tolerability and efficacy measures based on the latest biomarkers associated with disease progression. Earlier long-term data from the phase 2 ANGEL-MS trial has shown that temelimab, a monoclonal antibody designed to neutralize a pathogenic retroviral envelope protein, pHERV-W Env, has a neuroprotective effect in MS patients.
Results expected in the second half of 2021
The start of this Phase 2 trial had been postponed due to the COVID-19 pandemic, to safeguard the wellbeing of MS patients and to prioritize treatment of COVID-19 patients. Thanks to the Karolinska Institutet, the trial resumed promptly after the situation allowed, and results remain expected in the second half of 2021.
“We are pleased to be able to resume this Phase 2 trial in collaboration with the respected researchers of the Karolinska Institutet and Stockholm’s Academic Specialist Center, following a necessary COVID-19-related postponement. Temelimab has already been shown to have a neuroprotective effect in MS and it has the potential to address the key unmet medical need of disability progression. We are looking forward to further exploring its therapeutic properties in this important study,” says David Leppert, Chief Medical Officer of GeNeuro.