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Title: A safety and pharmacodynamics study of temelimab, an antipathogenic human endogenous retrovirus type W envelope monoclonal antibody, in patients with type 1 diabetes.
Austin Authors: Curtin, Francois;Champion, Bernard;Davoren, Peter;Duke, Sally;Ekinci, Elif I ;Gilfillan, Chris;Morbey, Claire;Nathow, Thomas;O'Moore-Sullivan, Trisha;O'Neal, David;Roberts, Adam;Stranks, Stephen;Stuckey, Bronwyn;Vora, Parind;Malpass, Sam;Lloyd, David;Maëstracci-Beard, Nicole;Buffet, Bénédicte;Kornmann, Gabrielle;Bernard, Corinne;Porchet, Hervé;Simpson, Richard
Affiliation: Division of Clinical Pharmacology and Toxicology, Rue Perret-Gentil, University of Geneva, Geneva, Switzerland
Southern Adelaide Diabetes & Endocrine Services, Flinders Medical Centre, Bedford Park, South Australia, Australia
Keogh Institute for Medical Research, Queen Elizabeth II Medical Centre, Nedlands,, Western Australia, Australia
Division of Medicine, Lyell McEwin Hospital, Elizabeth Vale, South Australia, Australia
Southern Star Research, Gordon, New South Wales, Australia
GeNeuro SA, Geneva, Switzerland
Department of Pharmacology, University of Pretoria, Pretoria, South Africa..
Department of Clinical Medicine, Faculty of Medicine and Health Sciences, Macquarie University, Macquarie Park, New South Wales, Australia
Gold Coast Hospital, Diabetes and Endocrinology, Southport, Queensland, Australia
Department of Diabetes Endocrinology and Metabolism, Royal North Shore Hospital, St Leonards, New South Wales, Australia
Medicine (University of Melbourne)
Eastern Clinical Research Unit, Eastern Health and Monash University, Box Hill, Victoria, Australia
AIM Centre, Merewether, New South Wales, Australia
Ipswich Research Institute, Ipswich, Queensland, Australia
Mater Hospital, South Brisbane, Queensland, Australia
St. Vincent's Hospital, Department of Medicine, Fitzroy, Victoria, Australia
Barwon Health, Department of Endocrinology, Geelong, Victoria, Australia
Issue Date: Jul-2020
Date: 2020-03-12
Publication information: Diabetes, Obesity & Metabolism 2020; 22(7): 1111-1121
Abstract: 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). 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. 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. 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.
DOI: 10.1111/dom.14010
ORCID: 0000-0002-4570-1850
Journal: Diabetes, Obesity & Metabolism
PubMed URL: 32077207
Type: Journal Article
Subjects: disease-modifying drug, endogenous retrovirus, human endogenous retroviruses, monoclonal antibody, phase II study, temelimab, type 1 diabetes
Appears in Collections:Journal articles

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