GeNeuro Successful Phase 2a Clinical Study Reinforces Novel Approach to Treat Multiple Sclerosis

Patients Receiving First in Class GNbAC1 Mab Are Stable After One Year

GENEVA, Switzerland I September 3, 2014 I GeNeuro SA, a pioneer of new therapies for neurology disorders, announced today positive results from a one-year, open-label extension of a Phase IIa study. GeNeuro tested its monoclonal antibody GNbAC1 in 10 multiple sclerosis (MS) 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 MS.

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 program. A proof-of-concept clinical study to test the efficacy of GNbAC1 in MS will follow in 2015.

Francois Curtin, CEO of GeNeuro stated: “We are very excited by the potential that GNbAC1 offers as a new avenue to treat MS patients. In addition to confirmation of long-term safety of the monoclonal antibody in patients, we have seen that the cohort of progressive MS 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 MS 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.”

About Multiple Sclerosis

Multiple Sclerosis is an autoimmune disease affecting the brain and spinal cord, driven by inflammatory and neuro-degenerative processes. It damages the myelin sheath, the material that surrounds and protects nerve cells, resulting in axonal damage. This slows down or blocks nervous conduction between the brain and the body, which leads to the symptoms of MS. The causes of MS are still unclear.

This disease takes three main forms:

  • Primary Progressive Multiple Sclerosis (PPMS, about 10% of patients at onset), where symptoms continually worsen from the time of diagnosis.
  • Remitting Relapsing MS (RRMS, about 90% of patients at onset), characterized by unpredictable attacks of neurological symptoms followed by partial or complete recovery.
  • Secondary Progressive MS (SPMS), developed after several years of relapsing-remitting MS, in which symptoms worsen without relapses or remissions.

Present MS treatments address RRMS forms, targeting the patient’s immune system to lower the frequency of relapses, with no proven impact on overall disability progression, and at the cost of an increased risk of opportunistic infections and cancers. There is no approved treatment for SPMS or PPMS forms of the disease (about 40% of total MS patients).

About GeNeuro and its technology

GeNeuro is a Swiss-based company developing first-in-class therapies against diseases associated with the expression of pathogenic proteins of human endogenous retroviral origin (HERV). Its lead product GNbAC1 targets MSRV-Env, a protein expressed in MS lesions from an early stage, which has been shown to be both pro-inflammatory and an inhibitor of remyelination, the two major drivers of MS progression.

The Multiple Sclerosis associated retrovirus (MSRV) is a member of the HERV-W family and was initially isolated in cell cultures from patients affected with Multiple Sclerosis. MSRV is normally latent in the genome of individuals, but it can be re-activated by viral infections and other co-factors to express a pathogenic protein, MSRV-Env. MSRV-Env provides the missing link between the observation that viral infections are associated with the onset of the disease and expression of pathogenic factor (the MSRV-Env protein), which can then explain the inflammatory and demyelinating characteristics of MS.

By targeting MSRV-Env, GeNeuro expects to bring to patients a safe, long-term treatment that can halt progression of the disease, addressing both the inflammatory and demyelinating mechanisms relevant for all forms of MS. As the first drug addressing a causal factor of the disease, it will radically change the way MS patients are treated.

SOURCE: GeNeuro

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