Therini Bio Reports Positive Phase 1a Results for THN391 in Neurodegenerative Diseases

On April 29, 2025, Therini Bio, Inc., a company advancing in the realm of biotechnology, revealed promising outcomes from a Phase 1a clinical trial of its leading candidate, THN391. This trial, which involved healthy subjects, is a part of their initiative to develop treatment options for neurodegenerative diseases associated with vascular irregularities. The findings will be showcased at the Alzheimer's Association International Conference 2025 (AAIC 25) in Toronto, Canada, on July 30, 2025.

THN391 emerges as a groundbreaking, humanized monoclonal antibody that is formulated to target and inhibit fibrin-induced neuroinflammation without disrupting the coagulation pathways. Fibrin deposits at locations of vascular malfunction engage complement receptors on immune cells, causing inflammation and potential neuronal harm in the brain and retina. Preclinical investigations into Alzheimer's disease and retinal conditions have demonstrated that antibodies against fibrin-associated inflammation can effectively prevent both vascular and neuronal damage.

During the Phase 1a study, which was randomized, double-blind, and placebo-controlled, the safety, tolerability, and pharmacokinetics of THN391 were examined in various single and multiple ascending doses among healthy participants. The results indicated that THN391 was well-tolerated, with no significant adverse events. It also maintained a favorable hematological profile, indicating no effects on coagulation and fibrinolysis, and did not result in an anti-drug antibody response. Moreover, THN391 exhibited dose-proportional pharmacokinetics and a half-life that supports a once-monthly dosing regimen.

Dr. Tara Nickerson, CEO of Therini Bio, commented on the significant advancement that this trial represents for a novel category of drugs aimed at treating neurodegenerative conditions. By focusing on vascular dysfunction and persistent neuroinflammation, Therini Bio seeks to tackle fundamental contributors to neurodegeneration. The promising data from this trial, along with strong preclinical support, energizes the company to accelerate THN391’s development to potentially enhance the well-being of individuals afflicted with debilitating illnesses such as Alzheimer's and Diabetic Macular Edema.

The company plans to initiate two Phase 1b trials soon, to further assess THN391's efficacy for treating Alzheimer's Disease and Diabetic Macular Edema. Therini Bio's mission centers around developing groundbreaking immunotherapies that address neuroinflammation in disorders driven by vascular dysfunction. Their pipeline features potential first-in-class therapies that specifically target harmful fibrin build-up in diseases where neuroinflammation is a principal factor, like Alzheimer's disease and Diabetic Macular Edema.

Therini Bio's exceptional group of life sciences investors includes notable organizations such as the Alzheimer’s Drug Discovery Foundation, SV Health Investors’ Biotech Fund, Dementia Discovery Fund, and many others, who are keen to back the development of these innovative treatments.