Clinical Trials

By targeting the fundamental underlying mechanisms of neurodegeneration in MS, i.e. neutralizing microglial-mediated damage, as well as restoring oligodendrocyte precursor cells (OPC) remyelination capacity, temelimab may address the critical unmet medical need of blocking disability progression independent of relapses in MS.

Current studies

Temelimab as a Disease Modifying Therapy in Patients With Neuropsychiatric Symptoms in Long-COVID

https://clinicaltrials.gov/ct2/show/NCT05497089?term=temelimab&draw=2&rank=1

The GNC-501 study, entitled “Temelimab as a Disease Modifying Therapy in Patients with Neurological, Neuropsychological, and Psychiatric Symptoms in Post-COVID-19 or Post-Acute Sequelae of COVID-19 (PASC) Syndrome”, will enroll 200 patients from Swiss and EU study centres suffering from severe neuropsychiatric syndromes following COVID infection. The biomarker-based study will enrol only patients who are also tested positive for the pathogenic protein W-ENV, with the objective to reduce their invalidating conditions.

Current active sites:

Geneva, Switzerland: Hôpital Universitaire de Genève - https://recherche.hug.ch/etudes/temelimab

Completed studies

The ProTEct-MS clinical study

GeNeuro’s ProTEct-MS study, which has tested monthly doses of 18, 36 and 54 mg/kg of temelimab on 41 patients, was conducted at the Academic Specialist Center (ASC) of the Karolinska Institutet, Stockholm, Sweden, in a double-blind, placebo-controlled fashion and was designed to evaluate the safety, tolerability and efficacy of the product based on the latest biomarkers associated with disease progression. The topline results of the ProTEct-MS study were announced on March 21, 2022, and showed that the primary endpoint of the ProTEct-MS study was met, with results confirming the excellent safety profile and tolerability of higher doses of temelimab administered concomitantly with a high-efficacy anti-inflammatory drug; in addition, efficacy data, obtained in this patient group already effectively treated against inflammation, showed that temelimab has a favorable impact on key MRI measures of neurodegeneration; the observed effect sizes in this new patient population were consistent with the ones shown in the previous CHANGE-MS and ANGEL-MS studies.

The top-line results of this study were communicated in March 2022. The complete results will be presented at ECTRIMS 2022

 

Completed studies

Multiple Sclerosis Phase II: CHANGE-MS and its ANGEL-MS extension

In March 2019, GeNeuro published the top-line 96-week results of its extension Phase 2b clinical trial, ANGEL-MS, which demonstrated that the 18mg/kg dose of temelimab had remarkably consistent benefits over all other groups on key MRI measures linked to MS disease progression, thereby confirming and extending the results of CHANGE-MS at Week 48.

The data showed that, after two years of treatment, the patients originally randomized to 18 mg/kg temelimab showed evidence of continued improvements in MRI-based neurodegenerative outcomes, such as brain volumes, magnetization transfer ratio (MTR) and black holes during ANGEL-MS up to 96 weeks compared to all other groups. Importantly, these effects were not driven by an anti-inflammatory effect. These data were presented at ECTRIMS 2019 in Stockholm, Sweden. 

As the study demonstrated, temelimab continued to be safe and well tolerated over this extended treatment period, which allows new therapeutic solutions in combination with anti-inflammatory drugs or as a monotherapy to be considered, with the objective to bring new benefits against disease progression across all forms of MS.

ANGEL-MS (Assessing the HERV-W Env ANtagonist GNbAC1 (temelimab) for Evaluation in an open label Long-term Safety Study in patients with Multiple Sclerosis) was a 2-year safety and efficacy extension study to CHANGE-MS (a 270 RRMS patients Phase II clinical trial in 50 clinical centers in 12 European countries), which offered continued treatment to those patients who had completed the 12-month primary study. Ninety-four percent of eligible patients (n=219) entered ANGEL-MS and continued treatment at the same dose of temelimab they were receiving at the end of CHANGE-MS. Across the two studies, a total of 154 patients received temelimab treatment for 96 weeks or more.