GeNeuro in brief

Temelimab: the first treatment that directly targets a potential cause of multiple sclerosis

Temelimab: the first treatment that directly targets a potential cause of multiple sclerosis. GeNeuro is developing a new approach to treating MS by seeking to block upstream neurodegenerative mechanisms that fuel disease progression, without interfering with the body's immune response. This approach is the result of 25 years of research into human endogenous retroviruses (HERVs), including 15 years within the Institut Mérieux group and INSERM, before GeNeuro was founded in 2006.

That research led to the discovery of a potentially causal factor of multiple sclerosis: the pathogenic HERV-W envelope protein (pHERV-W Env), which is expressed by genes that are normally silent. The presence of MSRV-Env in patients' brains could cause the inflammation and neurodegeneration that characterize MS.

GeNeuro has therefore developed temelimab, a monoclonal antibody, which has recently completed Phase IIb of clinical development, as a treatment for multiple sclerosis. Temelimab neutralizes the pHERV-W Env protein without targeting the patient's immune system, and could be a treatment that is both safe and effective in slowing or stopping the disease's progress in all its forms.

A new therapeutic approach at a time when no currently available treatment appears to have any significant impact on the disease's progression

Multiple sclerosis affects one in every 1,000 people in western countries. It is an autoimmune disease affecting the central nervous system, and is the leading cause of non-traumatic disability among young adults. The market for MS treatments is estimated to be worth almost $20 billion per year.

No currently available treatment for MS appears to diminish in a determining manner the long-term progression of the disease toward disability. Most current treatments are approved for "relapsing " forms of MS (RMS), which affect 60% of patients, through modulating or suppressing the patient's immune system. These treatments reduce the number of inflammatory relapses, but experience demonstrates that they do not alter substantially the progression of the disease. New therapeutic approaches are needed to slow-down and stop the progression of disability, and GeNeuro believes that its approach against a causal factor driving disease progression may bring unique benefits to patients. 

Other potentially extremely promising opportunities in areas other than multiple sclerosis

GeNeuro intends to capitalize on its technology's potential by developing a therapeutic platform focusing on diseases potentially caused by human endogenous retroviruses. The other indications being explored by GeNeuro include CIDP (chronic inflammatory demyelinating polyneuropathy) – an orphan neurological disease –, type-1 diabetes, amyotrophic lateral sclerosis and inflammatory psychosis. GeNeuro is currently conducting a phase IIa safety and pharmacodynamic study on adult type 1 diabetes patients, with positive 6-month results and full 1-year results expected for 2Q2019. GeNeuro is also developing a new antibody against another pathogenic member of the HERV family, in partnership with the US NIH, aiming at obtaining an IND by mid-2020.