Olatec Therapeutics has started a Phase II clinical trial for its NLRP3 inhibitor, dapansutrile, targeting patients with type 2 diabetes (T2D) mellitus and related complications.
The DAPAN-DIA Study, a randomised, double-blind, placebo-controlled trial, aims to enrol approximately 300 patients across multiple European centres.
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The trial will assess the efficacy and safety of dapansutrile in subjects with T2D who exhibit low-grade inflammation, obesity, and inadequately controlled glycemia despite standard therapy.
Olatec said the six-month treatment period involves administration of either dapansutrile or a placebo.
The Phase II Type 2 Diabetes DAPAN-DIA study is being carried out as an investigator-sponsored study at the University Hospital of Basel in Switzerland.
It is conducted under principal investigator Marc Donath at the University Hospital of Basel.
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By GlobalDataOlatec Therapeutics chief medical officer Mustafa Noor said: “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.”
The DAPAN-DIA Study is set to expand to diabetes centres across Europe, including institutions in Paris, Düsseldorf, and Liège.
The trial is funded by the European Union under the Horizon Europe Programme and the Swiss Government, in collaboration with Olatec, through the INTERCEPT-T2D initiative.
The INTERCEPT-T2D consortium, coordinated by Nicolas Venteclef U1151 at the French National Institute of Health and Medical Research (INSERM), includes Olatec and several European diabetes centres.
Olatec founder and CEO Damaris Skouras said: “Building on our previous data in heart failure and gout, the DAPAN-DIA Study represents a major milestone in the development of dapansutrile in the inter-related cardiometabolic diseases linked by chronic low-grade inflammation due to NLRP3/IL-1 activation.”
Earlier this year, Olatec received a grant to commence a Phase II clinical trial of dapansutrile to slow down or stop Parkinson’s disease progression.
