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

Regulatory News:

GeNeuro (Paris:GNRO) (Euronext Paris: CH0308403085 - GNRO), a biopharmaceutical company developing new treatments for neurodegenerative and autoimmune diseases such as multiple sclerosis (MS) and type-1 diabetes (T1D), today announced that a six-month extension of its Phase IIa study of temelimab (GNbAC1) in T1D confirmed all previously-observed positive observations in the trial, meeting its primary objective. GeNeuro believes these data open the door to further development in early-onset T1D pediatric patient population.

In the extension, all patients were treated with temelimab, including those previously on placebo. Data confirmed a very strong safety profile, with no serious related adverse events over the one-year study period, and a continued benefit on the number of hypoglycemic events. The positive effects observed in the 6-month double-blind placebo-controlled period were extended to those patients who switched to temelimab from placebo in the open-label extension period. Pharmacodynamic (PD) markers, such as anti-insulin antibodies, also improved once the placebo population switched to temelimab.

“These excellent results further expand the solid set of positive clinical data we have compiled on temelimab. It also provides more evidence for our approach in targeting pHERV-W Env in combination with concomitant medications in a new therapeutic setting. Temelimab is a very promising drug candidate with the potential to significantly improve the lives of patients not only with T1D, but also multiple sclerosis, where we have seen exciting evidence of neuroprotection. Based on these results, we will explore further clinical development in T1D, where we aim to test this potential disease modifying approach in larger early-onset populations,” said Jesús Martin-Garcia, CEO of GeNeuro.

Temelimab is a monoclonal antibody designed to neutralize a pathogenic envelope protein, pHERV-W Env, encoded by a member of the Human Endogenous Retrovirus W family. This protein has been detected post mortem in about two thirds of the pancreas of patients with T1D, its toxicity on the pancreas has been validated in preclinical models, and it is thought be a key factor in the onset and development of the disease. Neutralizing the toxicity induced by pHERV-W Env in the pancreas may provide a specific and safe disease modifying therapy for T1D patients.