Study of Temelimab in MS Progression Without Relapse Enrolls 1st Patient

GeNeuro announced that a first multiple sclerosis (MS) patient has enrolled in its Phase 2 trial assessing the safety and effectiveness of temelimab in people whose disease is progressing in the absence of relapses.

This trial, taking place at the Karolinska Institutet’s Academic Specialist Center (ASC), in Stockholm, had been postponed to reduce risk to MS patients during the global COVID-19 pandemic and to prioritize medical resources to treating those infected with this coronavirus.

“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,” David Leppert, chief medical officer of GeNeuro, said in a press release.

Temelimab, previously known as GNbAC1, is a monoclonal antibody that blocks inflammation by neutralizing the pHERV-Env protein associated with MS (formerly known as MSRV-Env). This protein has been shown to activate microglia (immune cells that cause inflammation in the brain), leading to aggressive attacks on the protective myelin sheath of nerve cells.

This one-year, single center Phase 2 study will assess temelimab’s safety, tolerability, and efficacy in up to 40 people “whose disability progresses without relapses, the key unmet medical need in multiple sclerosis,” the company stated in its release.

It aims to build on the results of two previous studies of temelimab in people with relapsing-remitting MS: the Phase 2 CHANGE-MS trial (NCT02782858) and its extension, the Phase 2b ANGEL-MS (NCT03239860). Both trials reported positive results, including slower disease progression and lesser evidence of brain atrophy in treated patients.

“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,” Leppert said. “We are looking forward to further exploring its therapeutic properties in this important study.”

Treatment safety and tolerability will be assessed at increasing dose levels, and signs of efficacy evaluated through biomarker analysis.

Results from this progressive MS study, led by Fredrik Piehl, MD, a professor of neurology at Karolinska and head of research at the MS clinic at ASC, are expected in the second half of 2021.

HERV proteins are thought to be derived from viral DNA that has been embedded into the human genome. The activity of these proteins is normally suppressed, but GeNeuro speculates that they may be activated in MS, and potentially in other neurodegenerative and autoimmune diseases.

GeNeuro and the Karolinska Institutet announced their collaboration in late 2019.