NodThera Charts Obesity Future with First Patients Dosed in Phase 2 RESOLVE-1 Trial of Oral NLRP3 Inflammasome Inhibitor NT-0796
- Pioneering small-molecule program, NT-0796, targets chronic inflammation and its fundamental role in the complex cycle of weight regulation
- Oral, brain-penetrant NLRP3 inflammasome inhibitor being investigated as monotherapy in 24-week Phase 2 RESOLVE-1 trial in 160 patients with obesity, with and without type 2 diabetes
- Combination trial planned with GLP-1RA to improve efficacy and tolerability of marketed anti-obesity treatments
- NT-0796 uniquely positioned as an oral, well-tolerated, small molecule therapeutic to enable sustained and healthy weight loss
- Acceleration of NT-0796 program follows $50 million Series D financing
Philadelphia, PA, June 4, 2025 – NodThera, a leading clinical-stage biotech delivering a paradigm shift in the treatment of chronic inflammatory diseases through selective modulation of the NLRP3 inflammasome, today announces that the first patients have been dosed in its Phase 2 RESOLVE-1 (RESolution Of infLammation to treat obesity and cardioVascular disEase) clinical trial investigating the potential of its lead candidate, oral NLRP3 inflammasome inhibitor NT-0796, in patients with obesity.
NodThera’s pioneering approach to obesity treatment is built on the growing understanding of the impact of chronic inflammation on the body and its fundamental role in the complex cycle of weight regulation which balances calorie intake, energy expenditure and satiety. While current drugs have made significant achievements in the management of obesity, their mechanisms primarily suppress the desire to eat (calorie restriction) or they promote a feeling of fullness, ultimately reducing food intake. NodThera’s approach goes beyond the reduction of food intake by resetting the body’s weight regulatory system and correcting the underlying imbalance, to return the body to its natural metabolic state.
Daniel Swisher, Chief Executive Officer of NodThera, commented: “With its novel molecular mechanism, the convenience of oral dosing without titration, and a well-tolerated safety profile, this fully brain-penetrant NLRP3 inflammasome inhibitor is projected to have a transformative impact on obesity by bringing the body back to balance. I am delighted that, following our recently closed $50 million Series D financing, we have accelerated our lead program into this robust Phase 2 trial, building on an impressive preclinical and clinical data set. This will support the progression of NT-0796 as an enhanced treatment for weight management, to enable patients to achieve sustained and healthy weight loss.”
RESOLVE-1 is a randomized, double-blind, placebo-controlled Phase 2 trial that will evaluate the efficacy and safety of NT-0796 in patients with obesity, with or without type 2 diabetes, over 24 weeks. 160 patients are expected to be randomized into three treatment groups, receiving twice daily oral NT-0796, once daily oral NT-0796 or placebo. The trial’s primary endpoint is the change in body weight in participants from baseline to week 24. Secondary endpoints include the impact of NT-0796 on body composition, metabolic biomarkers, and HbA1c levels in participants with type 2 diabetes. Headline data from the study are anticipated in Q2 2026.
Returning the body to its natural metabolic balance – homeostasis
Earlier preclinical and clinical work undertaken by the Company has demonstrated that NLRP3, an intracellular sensor and master switch that modulates inflammation, plays a key role in controlling obesity and obesity-associated inflammation. The fully brain-penetrant NT-0796 reduces inflammation in the brain, as well as throughout the body, to restore multiple dysregulated cardiometabolic pathways. The inhibition of NLRP3 results in the loss of fat mass, while preserving lean muscle mass, and restores the body’s natural metabolic balance (homeostasis), enabling sustainable, enhanced and healthy weight loss.
Positive clinical data announced by the Company in June 2024, from a Phase 1b/2a cardiovascular risk study in patients with obesity, confirmed NT-0796’s profound anti-inflammatory effect and supported its anti-obesity potential. This followed the publication of preclinical data in the Journal of Pharmacology and Experimental Therapeutics, demonstrating the potential of NT-0796 to reverse diet-induced obesity and inflammation in an animal model of the disease, matching weight loss driven by the GLP-1 receptor agonist, semaglutide. Most recently, data published in the journal Obesity showed the enhanced weight loss effect of NT-0796 when combined with semaglutide in a preclinical obesity model. The potential of NT-0796 to improve the efficacy and tolerability of existing GLP-1RA obesity therapies will be further investigated in NodThera’s upcoming Phase 2 combination trial, RESOLVE-2, expected to commence in H2 2025.
Alan Watt, President and Chief Scientific Officer of NodThera, added: “Through central NLRP3 inhibition and the correction of multiple dysregulated pathways in the brain and throughout the body, NT-0796 has the potential to deliver robust weight loss and broad cardiometabolic benefits that go beyond those seen with current therapies. NodThera’s treatment approach, restoring the body’s natural metabolic balance, would be game-changing.”
For more information about NodThera please contact:
NodThera
Tel: +44 (0) 1223 608130
Email: info@nodthera.com
ICR Healthcare
Amber Fennell, David Daley
Tel: +44 (0)20 3709 5700
Email: nodthera@icrhealthcare.com
About NodThera
NodThera is a leading clinical-stage biotech developing brain-penetrant NLRP3 inflammasome inhibitors to treat chronic inflammatory diseases. Led by an experienced management team, NodThera is combining a deep understanding of NLRP3 inhibition, pharmaceutical neuroscience expertise and precision chemistry. Its two lead clinical candidates are oral, small molecule NLRP3 inflammasome inhibitors, which have demonstrated differentiated, potentially best-in-class clinical profiles with significant anti-inflammatory effects and high brain penetration, offering distinct opportunities to treat multiple indications. The Company is backed by top-tier investors including 5AM Ventures, Blue Owl Capital, Epidarex Capital, F-Prime Capital, Novo Holdings, Sanofi Ventures and Sofinnova Partners. NodThera is headquartered in Philadelphia, Pennsylvania, with additional operations in Cambridge, UK. Learn more at www.nodthera.com or follow the Company on LinkedIn.
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