Dosing begins in trial testing treatment for MS, obesity
TNV262 also targets cardiovascular disease, other conditions
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A patient has blood drawn. (Photo by iStock)
- TNV262,a therapy for MS, obesity, and cardiovascular disease, is in a Phase 1 trial.
- It targets the NLRP3 protein, whose abnormal activation contributes to inflammation in these conditions.
- TNV262 can reach the brain and spinal cord, aiming for broad anti-inflammatory effects.
The first participant has been dosed in a Phase 1 clinical trial testing TNV262, an experimental therapy that Tenvie Therapeutics is developing as a potential treatment for multiple sclerosis (MS) and other conditions including obesity and cardiovascular disease.
The Phase 1a/1b study will test single and multiple doses of TNV262 in healthy volunteers and people with obesity. The main goal of the early study is to evaluate the safety, tolerability, and pharmacological properties of the experimental medication.
“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,” Tony Estrada, PhD, president and CEO of Tenvie, said in a company press release.
TNV262 is designed to block the activity of the protein NLRP3. Normally, NLRP3 acts as a key part of a molecular security system that helps defend the body against infection: when NLRP3 detects an infection, it activates an immune response to fight the threat. But in inflammatory diseases such as MS, abnormal activation of this pathway may contribute to disease progression.
“Dysregulation of the NLRP3 pathway has been implicated across multiple diseases characterized by chronic inflammation, including cardiometabolic conditions such as obesity and [cardiovascular disease],” said Tanya Z. Fischer, MD, PhD, Tenvie’s chief medical officer.
Reaching the brain
TNV262 can cross from the blood into the brain and spinal cord, meaning it should be able to suppress NLRP3 activity throughout the body, including the central nervous system (CNS, the brain and spinal cord).
Fischer said NLRP3-targeting therapies have shown promise for targeting inflammation outside the CNS, but “many existing programs have been limited by insufficient CNS exposure.”
Estrada said the newly launched Phase 1 study “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.”
In addition to testing safety and tolerability, the study’s main goals are to measure changes in biomarkers of inflammation and cardiometabolic risk. Secondary measures include changes in body weight and composition, as well as in appetite and eating behavior, in people with obesity.
The company plans to report preliminary trial data later this year. Pending positive results, Tenvie expects to initiate Phase 2 studies in MS, as well as cardiovascular disease and obesity.
“We look forward to evaluating the potential of TNV262 across a range of inflammation-driven indications, beginning with cardiometabolic diseases,” Estrada added.
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