CHANGE-MS Phase 2 Study Fully Enrolled Early, Results Due in Fall

GeNeuro recently announced that it has finished enrolling multiple sclerosis (MS) patients in the CHANGE-MS Phase 2b  study — several months ahead of schedule. The company now expects to report topline results in mid- to late autumn rather than at year’s end.

“Completing enrollment in CHANGE-MS several months sooner than previously anticipated is a significant achievement for our GNbAC1 development program and, most importantly, accelerates the timeline to potentially provide MS patients with a new and effective therapeutic option,” GeNeuro’s CEO, Jesús Martin-Garcia, said in a news release.

The CHANGE-MS (NCT02782858) study is evaluating the effect of GNbAC1 on 260 patients with relapsing-remitting multiple sclerosis (RRMS). Patients were enrolled at multiple clinical sites across Europe.

Its goal is to evaluate whether GNbAC1 can reduce RRMS patients’ active brain lesions — assessed through magnetic resonance imaging (MRI) — at six months and one year after treatment, compared to placebo.

GNbAC1 is a selective antibody that targets the protein MSRV-Env, which promotes inflammatory processes and the development of diseases such as MS. MSRV-Env is known to be present in brain lesions and in the blood of MS patients. By targeting the protein, GNbAC1 decreases inflammation and potentially promotes the remyelination of neurons.

GeNeuro and Servier also recently announced that patients will be able to continue their therapy with GNbAC1 for two more years in an extension study called ANGEL-MS, allowing researchers to collect more data on the treatment’s safety and efficacy profiles. This study is scheduled to enroll a first CHANGE-MS patient in April.

GeNeuro plans to start another GNbAC1 study, specifically enrolling secondary progressive MS patients in the United States, in the second half of this year. The study will investigate whether treatment with GNbAC1 can induce changes in biomarkers of inflammation, remyelination, and neuroprotection.

“2016 has been a transformative year for GeNeuro, with … the full recruitment of CHANGE-MS and the further strengthening of our team in order to execute additional clinical trials in 2017,” Martin-Garcia said. “We look forward to initiating these new studies and to the availability of the interim 6-month results from CHANGE-MS at the beginning of the fourth quarter of 2017.”