A novel therapeutic from GeNeuro to treat multiple sclerosis showed promising results in a one-year, open-label extension phase 2a clinical trial. GeNeuro tested its first-in-class GNbAC1 monoclonal antibody in ten multiple sclerosis patients, nine of whom have primary or secondary progressive multiple sclerosis.
“We are very excited by the potential that GNbAC1 offers as a new avenue to treat multiple sclerosis patients,” said Francois Curtin, CEO of GeNeuro, in a press release from the company. “In addition to confirmation of long-term safety of the monoclonal antibody in patients, we have seen that the cohort of progressive multiple sclerosis patients was stable over one year from both clinical and MRI standpoints.”
The trial, “Safety Study of GNbAC1 in Multiple Sclerosis Patients” was designed to compare GNbAC1 to a placebo for 177 days in single ascending doses and repeated administration. Although safety was the main outcome, the trial also evaluated drug distribution in the body, as well as effects of GNbAC1 on patients through MRI and serum analysis of MSRV-Env, a protein considered to be a major trigger for and activator of multiple sclerosis disease progression.
Patients showed excellent tolerability for repeated administration of GNbAC1, verifying the outcome of a phase 1 study that was a first-in-human trial. Moreover, the average Expanded Disability Status Score (EDSS) to measure disease progression was stable for patients over one year. Bolstering support for a future Phase 2 trial, patients showed stable brain images and reduced levels of MSRV-Env biomarkers. “This reinforces our conviction that GNbAC1 can completely transform the multiple sclerosis therapeutic landscape,” said Curtin.
The concept of GNbAC1 is unique and challenges the status quo of traditional multiple sclerosis therapies. According to Curtin, “Preliminary results of this study presented at the American Academy of Neurology earlier this year generated a high level of enthusiasm among clinicians as they see this treatment could bring new hope to patients as a safe therapy addressing a causal factor of the disease, breaking with the immunosuppressive logic of existing treatment.” To follow up these positive results, GeNeuro will begin a proof-of-concept clinical study in 2015.