GeNeuro, a biopharmaceutical company developing new treatments for neurological disorders and autoimmune diseases, has initiated a Phase 2a clinical study in Australia with GNbAC1 in patients with Type 1 diabetes (T1D).
GeNeuro said that GNbAC1 is a monoclonal antibody designed to neutralise MSRV-Env, a pathogenic protein that has been detected in the pancreas of T1D patients. GeNeuro is already evaluating GNbAC1 in Phase 2 clinical studies in patients with multiple sclerosis (MS), a disease in which evidence shows MSRV-Env to be a potential causal factor.
“Our extensive research on human endogenous retroviruses (HERVs) has suggested that there could be a causal role for MSRV-Env in other autoimmune diseases in addition to our lead program in multiple sclerosis. In Type 1 diabetes, MSRV-Env has been found in the pancreas of over 50 percent of patients post-mortem,” said Hervé Perron, Chief Scientific Officer of GeNeuro. “Our preclinical studies have showed that MSRV-Env causes a dose-dependent inhibition of insulin production, both in vitro and in animal models. These data, presented in February at the 2017 JDRF nPOD Annual Scientific Meeting in Florida, USA, and to be published later this year, provide a compelling rationale to start clinical studies in these diabetic patients.”
The company said that the placebo-controlled, randomized Phase 2a study will evaluate GNbAC1 in 60 recently diagnosed adults at over 10 centers in Australia. The primary endpoint will be safety in this new patient population, with secondary endpoints measuring the link between response and MSRV-Env biomarkers, measurement of insulin production based on C-peptide levels and other T1D-related biomarkers, such as insulin consumption, glycaemia and production of anti-beta cells antibodies.
Last patient enrolment is expected by end 2017 and data from this study are expected during the third quarter 2018, GeNeuro said.