GeNeuro announced that it has reached — more quickly than expected — the halfway mark for patient enrollment in its Phase 2b study, CHANGE-MS, assessing GNbAC1 as a therapy for relapsing-remitting multiple sclerosis (RRMS). Patient recruitment is continuing at sites across Europe.
The company also reported on the trial’s design in a poster presentation, “A placebo randomized controlled study to test the efficacy and safety of GNbAC1, a monoclonal antibody for the treatment of multiple sclerosis – rationale and design,” at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), recently held in London.
Monoclonal antibodies (mAbs) play an increasing important role in the therapeutic strategies against multiple sclerosis (MS), an inflammatory and degenerative disorder of the central nervous system. Most of the mAbs currently developed for MS are immunomodulators blocking the inflammatory immune process.
Growing evidence points to the ‘env’ genes of human endogenous retroviruses (HERVs) as being contributors to inflammatory processes, and consequently, possibly to the development of diseases like MS. In fact, the MSRV-Env (multiple sclerosis-associated retrovirus envelope) protein has been repeatedly detected in both brain lesions and the blood of MS patients.
In contrast to mAbs targeting immune function, GNbAC1, a humanized IgG4 mAb, targets the MSRV-Env protein. The MSRV-Env has been shown to have a pro-inflammatory action, and an ability to halt the differentiation of oligodendrocyte precursor cells (cells responsible for remyelinating brain lesions).
GNbAC1 neutralizes the MSRV-Env, blocking it from promoting inflammation and supporting the remyelination repair process.
CHANGE-MS (NCT02782858) is a double-blind, placebo-controlled study currently recruiting participants with RRMS. The trial is scheduled to enroll 260 patients at 69 clinical sites in 13 European countries; more information is available by clicking on the trial’s identification number, or by following this link.
The study aims to assess the cumulative number of active brain lesions (examined by magnetic resonance imaging, MRI) at six and 12 months after treatment with GNbAC1, and compare it to placebo controls (primary endpoint).
Secondary endpoints include the assessment of T2 lesion volume increase through week 24, the change in magnetization transfer ration (MTR), the annualized relapse rate, the change in brain volume, the percentage of patients with EDSS (Expanded Disability Status Scale) progression definite at three months, and the change in MS functional composite scores from baseline to week 48.
Preliminary study results are due late next year.
“Recruitment is progressing very well and faster than expected. It demonstrates the strong interest in this pioneering new treatment for MS. We remain on schedule to report initial results during Q4 2017,” Jesús Martin-Garcia, chief executive officer at GeNeuro, said in a press release. “MSRV-ENV is expressed in the active lesions of all types of MS. With this study, we believe we will establish the role of MSRV-ENV as a causal factor of MS and hopefully provide patients with a new and powerful avenue of therapy.”
“We are looking forward to the results of this study as CHANGE-MS is based on gold standard trial design for MS products in Phase 2 development. This provides us with a solid base to ascertain the potential of improving the standard of care through this novel causal pathway,” added François Curtin, MD, the company’s chief operating officer.
CHANGE-MS is fully funded by a partnership between GeNeuro and Servier. Servier is set to develop and commercialize GNbAC1 worldwide, if approved by regulatory agencies.