GeNeuro’s Temelimab Phase IIa Data in Type 1 Diabetes at 12 Months Confirms RAINBOW Positive Results - Seite 2

The Phase IIa randomized, placebo-controlled, safety and signal finding study (RAINBOW) evaluated temelimab in 64 adult patients diagnosed with T1D for up to 4 years, in 12 centers in Australia. The primary endpoint of the study was safety of temelimab administration in combination with T1D treatments. Secondary endpoints measured T1D biomarkers such as HbA1c, C-peptide levels, and other biomarkers associated with T1D, such as insulin consumption, glycaemia and production of diabetic auto-antibodies.

The well-controlled adult and late onset population in the study had been treated effectively and had low insulin needs and stable HbA1c and C-peptide levels, which remained stable during the trial. The group treated with temelimab for 12 months showed reduction of frequencies of hypoglycemic episodes under temelimab treatment in the initial 6-month double-blind phase (-28%, p<0.001 versus placebo), and a further reduction of 10% of hypoglycemic episodes in the second 6-month period. The group switching to temelimab from placebo showed reduction of the frequency of hypoglycemic episodes versus the previous placebo period (-29%), reaching the level of reduction observed with temelimab in the group treated for the first 6 months.

The small cohort size and low occurrence of events confirm excellent tolerability but do not allow for definitive efficacy conclusions.

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 GeNeuro

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 27 employees and rights to 17 patent families protecting its technology.

For more information, visit: www.geneuro.com

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