NodThera's NLRP3 inhibitorNLRP3 inhibitor shows further anti-inflammatory promise in phase 1b/2a obesity trial

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来源: FierceBiotech

The trial enrolled patients with obesity and elevated baseline C-reactive protein, a biomarker of chronic inflammatory diseases such as coronary artery disease.

NodThera’s NLRP3 inhibitorNLRP3 inhibitor has already proved its worth against Novo Nordisk’s blockbuster obesity drug in preclinical trials. Now, an early readout from a study in humans with obesity has again demonstrated the drug’s anti-inflammatory potential.

The phase 1b/2a trial saw patients with obesity and elevated baseline C-reactive protein (CRP)—a biomarker of chronic inflammatory diseases such as coronary artery disease—receive either NT-0796 or placebo over 28 days.

The data demonstrated a “highly statistically significant and rapid” reduction in CRP among patients who received NT-0796 compared to the placebo cohort, hitting the study’s primary endpoint.

In addition, more than 75% of the NT-0796 cohort achieved a CRP reduction of 2mg/L or more—considered a threshold for reducing cardiovascular risk—compared to less than 25% of those on placebo, NodThera noted in a June 12 release.

The biotech also pointed to reductions in other additional pro-inflammatory and cardiometabolic biomarkers, which it said built on its weight loss studies in mice as well as a phase 1b/2a study in patients with Parkinson’s disease.

“While all subjects lost weight due to calorie restriction in both the active and placebo groups, the most pronounced placebo-adjusted reductions in body weight were among high-risk subgroups of NT-0796 dosed subjects, and, with the company’s earlier preclinical data, support the anti-obesity potential of the molecule,” NodThera said in the release.

The company is now preparing to launch a 26-week phase 2 study in obesity alongside other mid-stage studies ranging from additional cardiometabolic diseases to Parkinson’s disease.

Today’s readout builds on the promise demonstrated by NT-0796 in both preclinical and clinical studies so far this year. In February, the company showed that NT-0796 caused weight loss at nearly the same rate as Wegovy in mice.

The results demonstrated that NLRP3 inhibitorsNLRP3 inhibitors are “uniquely positioned” over GLP-1 receptor agonists to block the initiation of cellular inflammatory responses to obesity-related damage-associated molecular patterns, researchers wrote in an article (PDF) published at the time in the Journal of Pharmacology and Experimental Therapeutics.

Last month, a phase 1b/2a study showed that NT-0796 resulted in mean reductions of key pro-inflammatory biomarkers in Parkinson’s patients.

NodThera President and Chief Scientific Officer Alan Watt, Ph.D., described today’s results as “an impressive data set, made all the more remarkable by being achieved within 28 days.”

“In addition to the profound anti-neuroinflammatory effects in Parkinson’s disease patients demonstrated previously, the data generated in this study of NT-0796 show improvements in inflammatory and metabolic biomarkers of CV risk that go beyond that seen with antibody and peptide therapies,” Watt added in the release.

“With additional reductions in body weight that should be enhanced with longer-duration dosing, NT-0796 is confirmed as a highly promising therapeutic agent for chronic inflammatory indications,” Watt said.

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