GeNeuro announced positive phase 2a trial results for temelimab, a monoclonal antibody that targets a protein implicated in the onset and development of type 1 diabetes, making the drug a potential disease-modifying therapy for the condition, according to a press release from the company.
Researchers observed a nearly 30% reduction in hypoglycemic events among adults with type 1 diabetes treated with temelimab, according to the release.
The temelimab therapy has been developed by Switzerland-based biopharmaceutical company GeNeuro and previously showed efficacy in limiting hypoglycemia during a 6-month Phase 2 placebo-controlled trial conducted in 64 adults with type 1 diabetes in Australia.
The findings are from a 6-month open-label extension of the randomized, double-blind controlled RAINBOW trial. In the original study, 64 adults in Australia with well-controlled type 1 diabetes received either temelimab or placebo in addition to their regular diabetes therapies for 6 months. During the extension, the original placebo group also received temelimab. Participants who continued temelimab had 10% fewer hypoglycemic events after already decreasing the frequency by 28% in the first 6 months compared with the placebo group (P < .001). There was a 29% decrease in hypoglycemic events in the group that switched from placebo compared with the first 6 months, according to the release.
No serious adverse events were reported during the study, and an improvement was observed in anti-insulin antibodies and other pharmacodynamic markers, according to the release.
“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,” Jesús Martin-Garcia, CEO of GeNeuro, said in the release. “Temelimab is a very promising drug candidate with the potential to significantly improve the lives of patients not only with [type 1 diabetes], but also multiple sclerosis, where we have seen exciting evidence of neuroprotection. Based on these results, we will explore further clinical development in [type 1 diabetes], where we aim to test this potential disease-modifying approach in larger early-onset populations.”