NodThera Demonstrates Reversal of Neuroinflammation and Inflammation in Parkinson’s Disease with Oral NLRP3 Inhibitor

NodThera, a biotech company that’s in the clinical stage, is focused on changing how we treat long-term inflammatory diseases by targeting the NLRP3 inflammasome. They’ve shared results from a Phase 1b/2a clinical trial in Parkinson’s disease, and the data has been fully published. The study looked at NT-0796, which is an oral medicine that can get through the blood-brain barrier and block the NLRP3 inflammasome. The findings were published in Movement Disorders, which is the official journal of the International Parkinson and Movement Disorder Society. The paper is called “Anti-neuroinflammatory and anti-inflammatory effects of the NLRP3 inflammasome inhibitor NT-0796 in subjects with Parkinson’s disease.” This is the first clinical evidence showing that an oral NLRP3 inhibitor can effectively treat Parkinson’s disease by crossing the blood-brain barrier.

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The trial found that NT-0796 was safe and well-tolerated, and it worked well both in the brain and throughout the body. It showed strong levels of the drug in the body and effectively targeted the NLRP3 inflammasome in both healthy people and those with Parkinson’s. The study showed that stopping NLRP3 activity reduced inflammation in the brain, as seen in the decrease of several important markers like IL-1β, which is linked to NLRP3 activity. Other markers, such as CCL2, IL-6, IL-8, and CXCL1, also dropped. There were also reductions in sTREM2 and neurofilament light, which are markers related to brain inflammation. Patients who had signs of inflammation in the body also showed lower levels of markers like high-sensitivity C-reactive protein, fibrinogen, IL-6, and IL-18.

These results show how effective NT-0796 is at reducing inflammation and suggest that NLRP3 activity in the brain is a big part of the inflammation that happens in Parkinson’s. This means that stopping NLRP3 could be a major way to treat the disease, helping reduce chronic low-grade inflammation that harms brain cells and makes the disease worse. Controlling this inflammation could help slow down the degeneration of brain cells that causes Parkinson’s symptoms.

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NodThera continues to focus on diseases that cause nerve damage and is moving quickly forward with their research on Parkinson’s, along with their main program for obesity. They are getting ready to start trials for NT-0150, a new version of an oral NLRP3 inhibitor that is better at getting into the brain and has strong effects on the central nervous system. These trials, which will start in the second half of 2025, will include Single Ascending Dose and Multiple Ascending Dose studies, leading up to a planned Phase 2 trial in people with Parkinson’s.

Daniel Swisher, Chief Executive Officer of NodThera, said, “This publication is a major milestone for NodThera and our goal to change the way Parkinson’s disease is treated by focusing on neuroinflammation. The data shows the strong scientific foundation of our approach and adds to the growing evidence that chronic low-grade inflammation isn’t just a result of Parkinson’s, but a driver of it. With the most advanced NLRP3 treatment plan and multiple first- and best-in-class inflammasome inhibitors, NodThera is uniquely positioned now to advance a neurodegeneration program targeting NLRP3, along with our lead obesity program, that we hope will change the way Parkinson’s is treated.”

Alan Watt, President and Chief Scientific Officer of NodThera, added, “These clinical results are really impressive, showing for the first time in people with Parkinson’s that we can successfully block NLRP3 activity in the brain and lower markers of brain inflammation that have long been linked to disease progression. The consistent and quick changes we saw in biomarkers, much of it within seven days, is very encouraging and opens up the possibility of a completely new treatment strategy that could change the course of the disease.”
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