Tenvie Therapeutics Announces First Subject Dosed in Phase 1 Trial of TNV313, Expanding Its Fully CNS-Penetrant NLRP3 Franchise

• Third drug candidate from Tenvie’s product engine to enter clinical development in 2026
• TNV313 joins TNV262 to give Tenvie two clinical-stage, fully CNS-penetrant NLRP3 inhibitors, enabling parallel development across distinct indications
• Phase 1 first-in-human study to evaluate single and multiple ascending doses of TNV313 in healthy volunteers
• Preliminary data expected in the first half of 2027

BRISBANE, Calif., Oct. 13, 2026 (GLOBE NEWSWIRE) -- Tenvie Therapeutics, a clinical-stage 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 TNV313, a fully CNS-penetrant small molecule inhibitor targeting NLRP3 for the treatment of neurologic, cardiometabolic, and ophthalmic diseases. The Phase 1 study will evaluate the safety and tolerability of single and multiple ascending doses of TNV313 in healthy volunteers.

“Dosing the first subject in our Phase 1 study of TNV313 marks the start of our third clinical program in less than a year, a pace that reflects the strength of our product engine and the execution of the Tenvie team,” said Tony Estrada, Ph.D., Co-Founder, President and CEO, Tenvie Therapeutics. “With TNV313, our NLRP3 franchise now includes two clinical-stage, fully CNS-penetrant small molecule inhibitors, allowing us to pursue a broader set of indications in parallel and giving us development and commercial optionality across the franchise. We look forward to sharing initial data from this study in the first half of 2027. During the same period, we expect to initiate Phase 2 proof-of-concept studies of TNV262 in obesity and cardiometabolic disease, as well as multiple sclerosis.”

“TNV313, like TNV262, is designed for best-in-class brain exposure at the lowest expected clinical dose, which we believe is essential to addressing neuroinflammation at its source,” said Tanya Z. Fischer, M.D., Ph.D., Chief Medical Officer of Tenvie Therapeutics. “Tenvie has deep expertise in designing fully CNS-penetrant small molecules that are not subject to active transporter-mediated efflux, giving us a differentiated ability to confidently estimate brain exposure from measured CSF and plasma concentrations and inform dose selection across indications. This allows us to advance TNV313 on its own development path, in parallel with TNV262.”

The TNV313 Phase 1 clinical trial is a first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending oral doses of TNV313 in healthy volunteers. The study will also validate CNS distribution and assess exploratory pharmacodynamic biomarkers. Tenvie expects to report preliminary safety, pharmacokinetic, and pharmacodynamic data in the first half of 2027. Based on the results of the Phase 1 study, Tenvie intends to advance TNV313 into Phase 2 studies.

About TNV313

TNV313 is an investigational, fully CNS-penetrant small molecule inhibitor of NLRP3, a key regulator of innate immune signaling implicated in a broad range of inflammatory diseases. Together with TNV262, TNV313 strengthens Tenvie’s NLRP3 franchise and provides strategic optionality to pursue differentiated development paths across neurologic, cardiometabolic, and ophthalmic indications. In preclinical studies, TNV313 demonstrated full CNS penetration and a favorable safety profile, supporting its advancement into Phase 1 clinical development.

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 programs, TNV262, TNV108, and TNV313, are in Phase 1 clinical development. TNV262 is a fully CNS-penetrant NLRP3 inhibitor being developed for cardiometabolic and neuroinflammatory indications, including obesity and cardiovascular disease, and multiple sclerosis. TNV108 is a peripherally restricted SARM1 allosteric inhibitor being developed for peripheral neuropathies. TNV313 is a fully CNS-penetrant NLRP3 inhibitor being developed for neurologic, cardiometabolic, and ophthalmic diseases. 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