Second candidate from Tenvie’s product engine to enter clinical development
Phase 1 first-in-human study to evaluate single and multiple ascending doses of TNV108 in healthy volunteers
Preliminary data expected in the second half of 2026
BRISBANE, Calif., April 20, 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 TNV108, an allosteric inhibitor targeting SARM1 for the treatment of peripheral neuropathies. The Phase 1 study will evaluate the safety and tolerability of single and multiple ascending doses of TNV108 in healthy volunteers.
“We are excited to advance our second clinical candidate as we pursue our mission to deliver precision-engineered small molecule therapies for neurological and peripheral diseases,” said Tanya Z. Fischer, M.D., Ph.D., Chief Medical Officer at Tenvie Therapeutics. “By targeting SARM1, a key driver of axonal degeneration, TNV108 is designed to address the underlying cause of peripheral neuropathy and its associated neuropathic pain. Supported by strong preclinical data, TNV108 has the potential to be the first disease-modifying therapy for patients living with peripheral neuropathies, starting with diabetic peripheral neuropathy (DPN).”
The Phase 1 clinical trial is a first-in-human trial designed to evaluate the safety, tolerability, pharmacokinetics, and exploratory pharmacodynamics of single and multiple ascending doses of TNV108 in healthy volunteers. Secondary objectives of this study include the assessment of structural and blood-based biomarkers of axonal integrity. Tenvie expects to report preliminary safety and pharmacokinetic data in the second half of 2026.
“Peripheral neuropathies represent a broad group of disorders characterized by progressive nerve degeneration, leading to debilitating numbness, pain, sensory loss and a significant impact on quality of life,” said Roy Freeman, M.D., Professor of Neurology, Director of the Center for Autonomic and Peripheral Nerve Disorders, Beth Israel Deaconess Medical Center. “Although progress has been made in the treatment of neuropathic pain management, existing therapies do not address the underlying axonal degeneration or meaningfully alter disease progression. We are optimistic about the prospect of new treatment options like TNV108 that aim to address complete disease mechanism and improve patient outcomes.”
About TNV108
TNV108 is an investigational, allosteric small molecule inhibitor of SARM1, a key mediator of axonal degeneration that drives neuronal loss through dysregulated nicotinamide adenine dinucleotide (NAD+) metabolism. By locking SARM1 in an inactive conformation, TNV108 fully inhibits SARM1 function, eliminating both NADase enzymatic activity and the immune response induced by pathogenic conformational change, thereby preventing axonal degeneration. By intervening upstream of irreversible axonal damage, TNV108 has the potential to preserve nerve integrity and modify disease progression. Initial clinical development of TNV108 is focused on peripheral neuropathies, starting with DPN. In preclinical studies, allosteric SARM1 inhibition demonstrated robust protection against nerve degeneration in diet- and chemotherapy-induced peripheral neuropathy models.
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 and TNV108, are in Phase 1 clinical development. TNV262 is a fully CNS-penetrant NLRP3 inhibitor targeting cardiometabolic and neuroinflammatory indications, including obesity and cardiovascular disease, and multiple sclerosis. TNV108 is a peripherally restricted SARM1 allosteric inhibitor targeting peripheral neuropathies. Tenvie’s clinical pipeline is complemented by discovery-stage programs across a range of related indications.
Investor & Media Contact:
Penelope Belnap
Precision AQ
Penelope.belnap@precisionaq.com
