Phase 1a trial for THN391 yields positive results

(Image credit: AdobeStock/Sana Sabina)

Therini Bio, Inc. shared positive results from a Phase 1a trial assessing its lead candidate, THN391, in healthy volunteers for the treatment of neurodegenerative diseases and retinal conditions. The data from this trial will be presented at the Alzheimer's Association International Conference 2025 (AAIC 25) in Toronto, Canada, on Wednesday, July 30, 2025.¹

The company’s candidate, 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 disease and retinal diseases, antibodies blocking fibrin inflammation demonstrated effectiveness in protecting against vascular and neuronal degeneration.¹

The Phase 1a trial was a randomized, double-blind, placebo-controlled trial that 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.

In the company’s press release¹, Tara Nickerson, PhD, Chief Executive Officer of Therini Bio spoke to the milestone that these positive data bring, saying, “The results of this trial mark an important milestone for a new class of drugs for the treatment of neurodegenerative diseases. 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 and diabetic macular edema (DME).”

Therini Bio intends to commence 2 Phase 1b trials evaluating THN391 for the treatment of patients with Alzheimer Disease and DME.

Reference:

1. Therini Bio Announces Positive Phase 1a Trial Results Evaluating THN391 for Neurodegenerative Diseases. Therini Bio, Inc. April 29, 2025. Accessed April 30, 2025. https://www.globenewswire.com/news-release/2025/04/29/3070399/0/en/Therini-Bio-Announces-Positive-Phase-1a-Trial-Results-Evaluating-THN391-for-Neurodegenerative-Diseases.html