GeNeuro has announced positive results from a one-year, open-label extension of a phase IIa study. GeNeuro tested its monoclonal antibody GNbAC1 in 10 multiple sclerosis patients, nine of which had primary or secondary progressive disease. GNbAC1 targets the MSRV-Env protein expressed by genes of endogenous retroviral origin, which GeNeuro believe plays a critical role in the pathogenesis of multiple sclerosis.
The long-term safety profile of GNbAC1 was confirmed, with excellent tolerability among patients following repeat administration, verifying results of the earlier phase I study. With respect to clinical endpoints, the average Expanded Disability Status Score (EDSS), which measures disease progression, remained stable over one year. MRI analysis revealed that the brain images also remained stable and biomarkers associated with the target showed a consistent decline. These results confirm the safety and tolerability of GNbAC1 and support a positive pharmacodynamic response to the treatment. The positive results of this clinical study represent the successful first step in GeNeuro’s phase II programme. A proof-of-concept clinical study to test the efficacy of GNbAC1 in multiple sclerosis will follow in 2015.
Francois Curtin, chief executive officer of GeNeuro states: “We are very excited by the potential that GNbAC1 offers as a new avenue to treat multiple sclerosis patients. 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. Moreover, there is a clear decrease in the associated biomarkers supporting a positive pharmacodynamic response. This reinforces our conviction that GNbAC1 can completely transform the multiple sclerosis therapeutic landscape.” Curtin adds: “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 that 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 treatments.”