Regulatory News:

GeNeuro (Paris:GNRO) (Euronext Paris: CH0308403085 – GNRO), a biopharmaceutical company developing new treatments for neurological and autoimmune diseases, such as multiple sclerosis (MS) and type 1 diabetes (T1D), announced today that patient enrollment in its Australian Phase 2a study of GNbAC1 in T1D has been completed on schedule. A total of 60 adult patients in more than 10 centers have been recruited into the study.

GNbAC1 is a monoclonal antibody designed to neutralize a pathogenic, viral envelope protein, encoded by a member of the Human Endogenous Retrovirus-W family (pHERV-W Env). This protein has been detected in patients with MS and in the pancreas of patients with T1D. It is thought to be a causal factor of these diseases.

“The objective of this Phase 2a study is to demonstrate GNbAC1’s safety and potential benefit in preserving pancreatic function in patients with type 1 diabetes. With patient enrollment now complete, we look forward to sharing data during the third quarter 2018,” said François Curtin, Chief Operating Officer of GeNeuro.

The Phase 2a randomized, placebo-controlled study will evaluate GNbAC1 in 60 recently diagnosed adult patients in over 10 centers in Australia. The primary endpoint is the safety of GNbAC1 in this new population of patients. Secondary endpoints will measure the link between treatment response and pHERV-W Env biomarkers, insulin production based on peptide C levels, and other biomarkers associated with type 1 diabetes, such as insulin consumption, glycaemia and production of diabetic auto-antibodies.

About Type 1 Diabetes

Type 1 diabetes, usually first diagnosed in children, is caused by an immune response directed against the insulin producing cells of the pancreas. There is no cure for this ‘autoimmune’ disease, which means patients need life-long treatment with insulin replacement. This treatment is often associated with several debilitating complications, including heart disease, blindness, and kidney disease, among others.

About GNbAC1

The development of GNbAC1 is the result of 25 years of research into human endogenous retroviruses (HERVs), including 15 years at Institut Mérieux and INSERM, a French national medical research institute. Found in the human genome, certain HERVs have been linked to various autoimmune diseases. Researchers have demonstrated that the toxic Env protein, pHERV-W Env, is observed in patients with MS, particularly in active lesions, and in the pancreas of T1D patients. By neutralizing pHERV-W Env, GNbAC1 could at the same time block these pathological inflammatory processes and restore remyelination in MS patients and maintain insulin production in T1D patients. As pHERV-W Env has no known physiological function, GNbAC1 is expected to have a good safety profile, without affecting the patient’s immune system, as observed in all clinical trials to date.

About GeNeuro

GeNeuro‘s mission is to develop safe and effective treatments against neurological disorders and autoimmune diseases, such as multiple sclerosis and Type 1 diabetes, 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 France in Lyon. It has 31 employees and rights to 16 patent families protecting its technology.

For more information, visit: www.geneuro.com

Disclaimer

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