- 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
BRISBANE, Calif., April 06, 2026 (GLOBE NEWSWIRE) -- Tenvie Therapeutics, a biotechnology company developing precision‑engineered small molecule therapies to transform the treatment of neurological and peripheral diseases, today 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.”
About TNV262
TNV262 is an investigational, fully CNS-penetrant small molecule inhibitor of NLRP3, a key regulator of inflammation within the innate immune system. By modulating a key driver of chronic inflammation across multiple conditions, TNV262 has the potential to address a broad range of inflammation- and neuroinflammation-driven diseases. Initial clinical development is focused on cardiometabolic diseases, including obesity and CVD, as well as MS. The fully CNS-penetrant profile of TNV262 also supports its potential in other diseases characterized by neuroinflammation-mediated disease progression. In preclinical studies, TNV262 demonstrated complete CNS penetrance and a favorable safety profile.
About Tenvie Therapeutics
Tenvie Therapeutics is developing precision‑engineered small molecule therapies to address core drivers of neurological and peripheral diseases: neuroinflammation and cellular dysfunction. Leveraging its proprietary product engine, Tenvie has the unique ability to advance both fully CNS‑penetrant and peripherally restricted products across a broad portfolio. Tenvie’s most advanced program, TNV262, a fully CNS-penetrant NLRP3 inhibitor, is in Phase 1 clinical development for cardiometabolic indications, including obesity and cardiovascular disease, as well as multiple sclerosis. In parallel, Tenvie is advancing TNV108, a peripherally restricted SARM1 allosteric inhibitor targeting peripheral neuropathies, through preclinical development. Tenvie’s clinical pipeline is complemented by discovery-stage programs across a range of related indications.
Investor Contact:
Penelope Belnap
Precision AQ
Penelope.belnap@precisionaq.com
