Swiss-based GeNeuro has started a Phase IIa clinical trial of GNbAC1 in Australia for the treatment of Type 1 diabetes (T1D) patients.
GNbAC1 is currently being developed to neutralise a pathogenic protein called MSRV-Env, and is a monoclonal antibody with potential to maintain insulin production in patients with T1D and block pathological inflammatory processes, as well as restore remyelination in multiple sclerosis (MS) patients.
The placebo-controlled, randomised Phase IIa trial is designed to assess GNbAC1 in 60 recently diagnosed adults at more than ten centres in the country.
GeNeuro chief scientific officer Hervé Perron said: “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 programme in multiple sclerosis.
"In Type 1 diabetes, MSRV-Env has been found in the pancreas of more than 50% of patients post-mortem.
“Our preclinical studies have showed that MSRV-Env causes a dose-dependent inhibition of insulin production, both in vitro and in animal models."
The trial's primary endpoint is safety, while the secondary endpoints include measure of link between response and MSRV-Env biomarkers and insulin production.
It is expected that trial enrolment will be completed by the end of this year and the results will be available during the third quarter of next year.
GNbAC1 is also currently being assessed in Phase II clinical trials for treating MS patients.