UK-based biotechnology company NodThera has dosed the first patients in a Phase Ib/IIa clinical trial of its NLRP3 inflammasome inhibitor NT-0796.

The trial aims to evaluate cardiometabolic biomarkers in patients with obesity and certain risk factors for atherosclerotic cardiovascular disease.

The dosing was initiated after NodThera received a “safe to proceed” letter from the US Food and Drug Administration in response to an investigational new drug application for NT-0796.

The placebo-controlled, double-blind, randomised study will assess the pharmacokinetic and pharmacodynamic (PK/PD) profile of the brain-penetrant candidate NT-0796.

It will also explore the potential of central NLRP3 inhibition in the brain to reduce gliosis and other consequences of obesity.

Up to 60 patients will be enrolled in the study and randomised into two cohorts to receive either NT-0796 or a placebo for 28 days.

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The trial’s primary endpoint is the change in baseline to day 28 of high-sensitivity C-reactive protein (CRP) levels, which is considered an important peripheral inflammatory marker and a known predictor of risk of developing atherosclerotic CV disease.

Its secondary endpoints include multiple inflammatory and CV-risk-specific biomarkers.

NodThera CEO Alan Watt said: “Our strategy at NodThera has been to develop small molecule NLRP3 inhibitors that penetrate both tissues and brain, not just for treating neurological disease but for treating the central components of peripheral disease that are caused by neurological dysfunction.

“Novel in-house preclinical findings have confirmed the importance of inhibiting brain NLRP3 in cardiometabolic disease models.

“In evaluating an obese population at high risk of cardiovascular disease we aim to assess the impact of NLPR3 inhibition on both peripheral inflammation and reactive gliosis, both of which contribute to cardiometabolic dysfunction.”

In a previous first-in-human study, NT-0796 showed its effects of brain penetration and anti-inflammatory while demonstrating an ‘excellent’ PK/PD profile in healthy subjects.