GeNeuro (Euronext Paris: CH0308403085 – GNRO) (Paris:GNRO), a biopharmaceutical company developing new treatments for neurodegenerative and autoimmune diseases such as multiple sclerosis (MS), type-1 diabetes (T1D) and amyotrophic lateral sclerosis (ALS), today announced positive results from the ANGEL-MS study of its lead product, temelimab in MS. Temelimab is a humanized, monoclonal antibody designed to neutralize pHERV-W, a pathogenic protein thought to be a causal factor in the development of multiple sclerosis.
The ANGEL-MS data confirmed that treatment with temelimab for 2 years had a continued, positive impact on key MRI measures of disease progression in multiple sclerosis patients, confirming and extending the data reported at Week 48 in the CHANGE-MS Phase 2b study. This includes reductions in brain atrophy, particularly in the cortex and thalamus, and maintenance in myelin integrity, as measured by magnetization transfer ratio (MTR) imaging. Importantly, for the first time, encouraging dose-dependent effects were seen on clinical measures of disease progression. This has been evidenced by a lower proportion of patients with 12-week confirmed EDSS progression, or with 20% worsening in 25-foot timed walk.
Jesús Martin-Garcia, CEO of GeNeuro, said: “We are extremely pleased with this data, which clearly confirm the robust and consistent effects of temelimab on key MRI markers of neuroprotection, and we are excited by the early signs of clinical benefit. The results of ANGEL-MS confirm the potential of temelimab to act against disease progression, the largest unmet medical need in this indication. It further reinforces our determination to continue the development of temelimab in MS.”
“These results are remarkable, and they are coherent with temelimab’s novel mode of action seeking to stop the activation of the brain’s innate immunity and restoring the myelin repair system”, noted Prof Hans-Peter Hartung, chairman of the Department of Neurology of the University Hospital Düsseldorf and Lead Investigator of the study. “It offers promise to treat progressive patients with low inflammatory activity, and could have potential synergies with existing anti-inflammatory drugs in relapsing MS patients.”
The development of temelimab (GNbAC1) is the result of more than 25 years of research into human endogenous retroviruses (HERVs), including 15 years within Institut Mérieux and INSERM before GeNeuro was founded in 2006. HERVs are present in the human genome and some have been associated with various auto-immune diseases. The viral envelope protein encoded by a HERV in the HERV-W family (pHERV-W Env) has been found in the brains MS patients, and particularly in active lesions, as well as in the pancreas of patients with in type-1 diabetes on pathological examination. By neutralising pHERV-W Env, temelimab could simultaneously block a pathological, neurodegenerative process and help to restore myelin integrity in MS patients, as well as to maintain insulin production in T1D patients. Given that the pHERV-W Env protein has no known physiological function, temelimab was expected to have a good safety profile, with no effect on the patient’s immune system and importantly this has been borne out by all clinical trials carried out to date.
GeNeuro‘s mission is to develop safe and effective treatments against neurological disorders and autoimmune diseases, such as multiple sclerosis, by neutralizing causal factors encoded by HERVs, which represent 8% of human DNA.
GeNeuro is based in Geneva, Switzerland and has R&D facilities in Lyon, France. It has 26 employees and rights to 17 patent families protecting its technology.
For more information, visit: www.geneuro.com
March 18, 2019