Multiple sclerosis (MS) patients now taking part in a Phase 2b clinical trial testing the efficacy and safety of the antibody GNbAC1 will be invited to continue with treatment for two more years under a planned extension study, the biopharmaceutical companies GeNeuro and Servier recently announced.
Several MS therapies rely on the capacity of antibodies to specifically target the dysregulated proteins that contribute to the disease’s pathology. GNbAC1 is a selective antibody that targets the protein MSRV-Env, which promotes inflammatory processes and the development of diseases such as MS. The MSRV-Env protein is known to be present in brain lesions and in the blood of MS patients. By targeting this protein, GNbAC1 aims to block inflammation, potentially facilitating the remyelination of neurons.
The ongoing Phase 2b study, called CHANGE-MS (NCT02782858), is assessing the effect of GNbAC1 in 260 patients with relapsing-remitting multiple sclerosis (RRMS) enrolled at multiple clinical sites across Europe.
Its primary endpoint is the cumulative number of active brain lesions (assessed through magnetic resonance imaging, MRI) evident at six months and one year after GNbAC1 treatment, compared to placebo, in RRMS patients.
Investigators will also analyze other neurological and disease status parameters as secondary endpoints, including T2 lesion volume increase up to week 24, change in magnetization transfer ratio (MTR), the annual relapse rate, change in brain volume, percentage of patients with EDSS (Expanded Disability Status Scale) progression at three months from baseline, and change in MS functional composite scores from baseline to week 48. The study’s preliminary results after six months of treatment are expected to be released in 2017.
According to a press release, the extension study, called ANGEL-MS, will allow patients to continue with GNbAC1 treatment for an additional two years, and allow investigators to collect more data on its efficacy and tolerance. The extension is planned to start in April, when all patients have completed the first year of GNbAC1 treatment under the CHANGE-MS trial.
ANGEL-MS will be conducted in parallel to Phase 3 studies that may arise from the results obtained in the CHANGE-MS trial. Similar to CHANGE-MS, the extension study will be fully funded by a partnership between GeNeuro and Servier.