Therini Bio Announces Positive Phase 1a Trial Results Evaluating THN391 for Neurodegenerative Diseases

- Novel approach to treat neurodegenerative diseases by targeting fibrin-driven neuroinflammation was well-tolerated among healthy volunteers, with a clean hematological profile -
- Half-life supports once-monthly dosing -
- Data to be presented at AAIC 25 -

SACRAMENTO, Calif., April 29, 2025 (GLOBE NEWSWIRE) -- Therini Bio, Inc., a clinical-stage biotech company developing fibrin-targeting immunotherapies for neurodegenerative diseases driven by vascular dysfunction today announced positive results from a Phase 1a trial assessing its lead candidate, THN391, in healthy volunteers for the treatment of neurodegenerative diseases. The data from this trial, which showcases Therini’s novel approach to treating neurodegenerative diseases, will be presented at the Alzheimer's Association International Conference 2025 (AAIC 25) in Toronto, Canada, on Wednesday, July 30, 2025.

THN391 is a potential first-in-class, high-affinity, humanized monoclonal antibody that is designed to selectively block fibrin-mediated neuroinflammation without interfering with coagulation pathways. At sites of vascular dysfunction, deposited fibrin binds complement receptors on innate immune cells triggering inflammation and neuronal damage in the brain and retina. In preclinical studies of Alzheimer’s disease and retinal diseases, antibodies blocking fibrin inflammation demonstrated effectiveness in protecting against vascular and neuronal degeneration.

The Phase 1a, randomized, double-blind, placebo-controlled trial assessed the safety, tolerability and pharmacokinetics (PK) of single and multiple ascending doses of THN391 in healthy volunteers. THN391 was well-tolerated, with no Serious Adverse Events reported. THN391 also demonstrated a clean hematological profile, with no impact on coagulation and fibrinolysis, and did not induce an anti-drug antibody response. Additionally, THN391 exhibited dose proportional PK and a half-life that supports monthly dosing.

“The results of this trial mark an important milestone for a new class of drugs for the treatment of neurodegenerative diseases,” said Tara Nickerson, Ph.D., Chief Executive Officer of Therini Bio. “By targeting vascular dysfunction and chronic neuroinflammation, we aim to address fundamental root causes of neurodegeneration. Galvanized by the encouraging data and compelling preclinical evidence, we are eager to accelerate the development of THN391 to potentially ameliorate the lives of patients devastated by debilitating diseases, including Alzheimer’s and Diabetic Macular Edema.”

Therini Bio intends to commence two Phase 1b trials imminently, evaluating THN391 for the treatment of patients with Alzheimer’s Disease and Diabetic Macular Edema.

About

Therini Bio is a clinical-stage biotech company developing immunotherapies for neuroinflammation in diseases driven by vascular dysfunction. Therini is developing a pipeline of potential first-in-class therapies selectively targeting toxic fibrin accumulation for diseases, including Alzheimer’s disease (AD) and Diabetic Macular Edema (DME), where destructive neuroinflammation plays a central role in the disease process. Therini Bio’s top-tier syndicate of life sciences investors includes the Alzheimer’s Drug Discovery Foundation, SV Health Investors’ Biotech Fund and Dementia Discovery Fund, Angelini Ventures, Apollo Health Ventures, Dolby Family Ventures, Dreavent Biotech Investments, Eli Lilly and Company, Foundation for a Better World, MRL Ventures Fund, the therapeutics-focused corporate venture fund of Merck & Co., Inc., and Sanofi Ventures. For more information, visit www.therinibio.com.

Contact

Tara Nickerson, Ph.D.
Chief Executive Officer
tnickerson@therinibio.com