Tenvie Therapeutics has dosed the first participant in its Phase I clinical trial of TNV108 to treat peripheral neuropathies.
The trial will assess the tolerability and safety of single and multiple ascending TNV108 doses in healthy volunteers.
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As a first-in-human study, it will also assess the pharmacokinetics and exploratory pharmacodynamics of TNV108. The study will also measure both structural and blood-based biomarkers of axonal integrity.
Tenvie anticipates reporting preliminary safety and pharmacokinetic results in the second half of 2026.
TNV108 acts as an allosteric small molecule inhibitor of SARM1, a principal mediator of axonal degeneration associated with disrupted nicotinamide adenine dinucleotide (NAD+) metabolism.
Initial clinical focus for TNV108 is on peripheral neuropathies, particularly diabetic peripheral neuropathy (DPN).
Preclinical studies showed that allosteric SARM1 inhibition protected against nerve degeneration in peripheral neuropathy models induced by diet and chemotherapy.
Tenvie Therapeutics chief medical officer Tanya Fischer said: “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.
“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 DPN.”
Tenvie Therapeutics’ clinical portfolio includes TNV262, a central nervous system (CNS)-penetrant nucleotide-binding domain, leucine-rich repeat–containing family, pyrin domain-containing-3 (NLRP3) inhibitor that targets cardiometabolic, neuroinflammatory, and neurological disorders.
The portfolio also features TNV108, which is aimed at treating peripheral neuropathies. Both candidates are currently in Phase I trials while additional discovery-stage programmes are ongoing across related disease areas.
