A safety and pharmacodynamics study of temelimab, an antipathogenic human endogenous retrovirus type W envelope monoclonal antibody, in patients with type 1 diabetes

Francois Curtin, Bernard Champion, Peter Davoren, Sally Duke, Elif I. Ekinci, Chris Gilfillan, Claire Morbey, Thomas Nathow, Trisha O'Moore-Sullivan, David O'Neal, Adam Roberts, Stephen Stranks, Bronwyn Stuckey, Parind Vora, Sam Malpass, David Lloyd, Nicole Maëstracci-Beard, Bénédicte Buffet, Gabrielle Kornmann, Corinne BernardHervé Porchet, Richard Simpson

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Aim: To report the first study of temelimab, a monoclonal antibody neutralizing the pathogenic human endogenous retrovirus type W envelope, in patients with type 1 diabetes (T1D). Materials and Methods: This double-blind, placebo-controlled, randomized clinical trial recruited adult patients with T1D within 4 years postdiagnosis and remaining C-peptide secretion. Sixty-four patients were randomized (2:1) to monthly temelimab 6 mg/kg or placebo during 24 weeks followed by a 24-week, open-label extension, during which all patients received temelimab. The primary objective was the safety and tolerability of temelimab. The secondary objective was to assess the pharmacodynamics response such as C-peptide levels, insulin use, HbA1c, hypoglycaemia and autoantibodies. Results: Temelimab was well tolerated without any group difference in the frequency or severity of adverse events. Concerning exploratory endpoints, there was no difference in the levels of C-peptide, insulin use or HbA1c between treatment groups at weeks 24 and 48. The frequency of hypoglycaemia events was reduced with temelimab (P = 0.0004) at week 24 and the level of anti-insulin antibodies was lower with temelimab (P < 0.01); the other autoantibodies did not differ between groups. Conclusions: Temelimab appeared safe in patients with T1D. Pharmacodynamics signals (hypoglycaemia and anti-insulin antibodies) under temelimab were observed. Markers of β-cell functions were not modified by treatment. These results need to be further explored in younger patients with T1D with earlier disease onset.

Original languageEnglish
Pages (from-to)1111-1121
Number of pages11
JournalDiabetes, Obesity and Metabolism
Issue number7
Publication statusPublished - Jul 2020


  • disease-modifying drug, endogenous retrovirus, human endogenous retroviruses, monoclonal antibody, phase II study, temelimab, type 1 diabetes

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