The first patient with T2DM and diabetes-related complications has been enrolled in the clinical trial, DAPAN-DIA, in Basel, Switzerland, with Olatec Therapeutics's NLRP3 inhibitor, dapansutrile. This Phase 2 randomised study is designed to evaluate dapansutrile's efficacy and safety in approximately 300 patients with elevated blood glucose, systemic inflammation and at risk for complications of diabetes, despite use of standard-of-care anti-diabetic therapy.
DAPAN-DIA represents the first T2DM clinical trial of any selective NLRP3 inhibitor in the emerging class that will also assess cardiometabolic and other risk factors beyond anti-hyperglycaemic effects including weight lowering efficacy in combination with GLP-1 therapy.
The trial is being funded by a consortium that includes Olatec, the European Union under the Horizon Europe Programme and the Swiss Government as part of the INTERCEPT-T2D initiative. The DAPAN-DIA study is being conducted under Principal Investigator, Dr Marc Donath at the University Hospital of Basel in Switzerland, a long-time Olatec collaborator and advisor as well as a leading researcher-clinician in immuno-metabolism.
"There is a large unmet need for effective treatment of T2D that goes beyond glycaemic control and addresses the underlying inflammatory component of the disease and its cardiometabolic complications,” said Marc Donath, Chief Physician, Clinic of Endocrinology, Diabetes & Metabolism, University of Basel. “The ground-breaking DAPAN-DIA Study has the potential for dapansutrile to represent a significant step forward in the management of T2D.”
The DAPAN-DIA Study is a randomised, double-blind, placebo-controlled multi-centre trial of the efficacy and safety of dapansutrile in subjects with T2D and diabetes-related complications. Target enrolment is approximately 300 patients who, upon entry into the trial, present with low-grade inflammation, obesity and inadequately controlled glycemia (elevated HbA1c) despite use of standard anti-diabetic therapy. Patients will be treated with dapansutrile or placebo for six months.
In addition to the Swiss sites, the trial is intended to be expanded at medical and scientific diabetes centres of excellence within Europe, including: Hôpital Lariboisière, Hôpital Bichat-Claude Bernard and Hôpital Cochin in Paris, France; German Diabetes Center, Düsseldorf, Germany; and University Hospital of Liège in Belgium.
"We expect the data from this trial, including the combination with GLP-1 therapy, will be highly relevant for understanding the full potential of anti-inflammatory intervention with an NLRP3 inhibitor in this setting," said Dr Mustafa Noor, Chief Medical Officer, Olatec Therapeutics.
Unlike existing diabetic treatments that primarily focus on glucose lowering, dapansutrile offers a novel approach to disease-course modification, by targeting the underlying NLRP3 inflammation pathway that is implicated in driving resistance to insulin action in T2D, promoting body weight gain and associated with higher cardiometabolic risks.
INTERCEPT-T2D, which stands for Early Interception of Inflammatory-mediated Type 2 diabetes, coordinated by Nicolas Venteclef U1151 at INSERM (French National Institute of Health and Medical Research) represents a consortium of entities including Olatec, and several established European diabetes centres in addition to the Hôpital Lariboisière, Hôpital Bichat-Claude Bernard and Hôpital Cochin in Paris, France; German Diabetes Center, Düsseldorf, Germany; and University Hospital of Liège in Belgium. Funding is being provided from both (i) European Union under the Horizon Europe Programme (GA 101095433) and (ii) the Swiss Government as part of the Horizon Europe Programme and State Secretariat for Education Research and Innovation, respectively.
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