• First candidate from Tenvie’s product engine to enter clinical development
• Phase 1 first-in-human study to evaluate single and multiple ascending doses of TNV262 in healthy volunteers and persons with obesity
• Preliminary data expected in the second half of 2026
  
  

Tenvie Therapeutics, a biotechnology company developing precision‑engineered small molecule therapies to transform the treatment of neurological and peripheral diseases, announced the first subject dosed in a Phase 1 clinical study evaluating TNV262, a fully CNS-penetrant small molecule inhibitor targeting NLRP3 for the treatment of cardiometabolic diseases, including obesity and cardiovascular disease (CVD), as well as multiple sclerosis (MS). The Phase 1a/1b study will evaluate the safety and tolerability of single and multiple ascending doses of TNV262 as well as cardiovascular and inflammatory biomarkers in healthy volunteers and persons with obesity.

“We are delighted to announce dosing of the first subject in our Phase 1 study of TNV262, an important milestone for Tenvie and our mission to transform the treatment of neurological and peripheral diseases with precision-engineered small molecules, made possible by the dedication of our team,” said Tony Estrada, Ph.D., President & CEO of Tenvie Therapeutics. “This trial represents the first clinical application of our CNS-first design approach—building maximum CNS penetration into the foundation of our chemistry to precisely engage key biological targets and intervene at the source of disease. We look forward to evaluating the potential of TNV262 across a range of inflammation-driven indications, beginning with cardiometabolic diseases.”

“Dysregulation of the NLRP3 pathway has been implicated across multiple diseases characterized by chronic inflammation, including cardiometabolic conditions such as obesity and CVD,” said Tanya Z. Fischer, M.D., Ph.D., Chief Medical Officer at Tenvie Therapeutics. “Although clinical validation of NLRP3 has emerged in peripheral indications, many existing programs have been limited by insufficient CNS exposure. As a fully CNS-penetrant NLRP3 inhibitor supported by encouraging preclinical data demonstrating robust suppression of inflammatory CV risk biomarkers, TNV262 is uniquely positioned to deliver disease-modifying effects for people living with obesity and CVD.”

The Phase 1 clinical trial is a first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics, and exploratory pharmacodynamics of single and multiple ascending doses of TNV262 in healthy volunteers and persons with obesity. Primary outcome measures include the safety and tolerability of TNV262, as well as biomarkers of inflammation and cardiometabolic risk. Secondary outcome measures will assess body weight and body composition, along with measures of appetite and eating behavior in persons with obesity. Tenvie expects to report preliminary safety and PK data in the second half of 2026. Pending positive results, Tenvie intends to initiate Phase 2 studies evaluating TNV262 in CVD and obesity, as well as in MS.

“Despite important advances in cardiometabolic care, many existing therapies primarily address downstream risk factors rather than the biological processes that drive disease progression,” said Donna Ryan, M.D., Professor Emerita at Pennington Biomedical Research Center. “Chronic, unresolved inflammation is increasingly recognized as a key contributor to obesity and CVD, and approaches that target neuroinflammatory pathways such as NLRP3 have the potential to meaningfully alter disease trajectory. This trial represents an important step toward transforming the future of care for individuals living with cardiometabolic diseases.”