NEW YORK – Therini Bio has started initial human testing of its fibrin-targeting investigational Alzheimer's disease drug, THN391, in a Phase I trial, the biotechnology company said Monday.
THN391, the company's lead asset, binds to a component of the protein fibrin, which is known to activate a pathological immune response in patients with neurodegenerative diseases like Alzheimer's as well as ophthalmologic diseases. Fibrin is critical for blood clotting and coagulation but can also cause inflammation when it accumulates in the brain.
The recently launched Phase I study will involve healthy volunteers. Therini Bio expects to have a safety and proof-of-mechanism data readout from that trial by the end of 2024. In future Phase II studies, the company plans to enroll patients with dementia, enriching for those who are likely to have higher levels of fibrin deposits vascularly, perivascularly, and parenchymally, based on genetic analysis and fibrinogen levels in cerebral spinal fluid.
THN391 is Therini Bio's first clinical-stage therapeutic candidate. The South San Francisco, California-based firm is also developing drugs for multiple sclerosis and diabetic macular edema.