US-based biotechnology company Therini Bio has reported positive results from a Phase Ia trial of THN391, a potential treatment for neurodegenerative conditions.
The placebo-controlled, double-blind trial evaluated the safety, pharmacokinetics and tolerability of single and multiple ascending doses of the therapy when given to healthy volunteers.
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The results showed that the therapy was tolerated well, without any serious adverse events observed.
THN391 also demonstrated a clean haematological profile, without indicating any effect on coagulation and fibrinolysis, and did not trigger any anti-drug antibody response.
In addition, it showed dose-proportional pharmacokinetics and a half-life, suggesting that monthly dosing could be possible.
THN391 is a high-affinity humanised monoclonal antibody designed to selectively inhibit fibrin-mediated neuroinflammation without disrupting coagulation pathways.
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By GlobalDataThis approach could address the retina and brain’s neuronal damage, as well as inflammation caused by accumulated fibrin attaching to complement receptors present on immune cells at the vascular dysfunction sites.
The drug is Therini Bio’s lead candidate and is now set to undergo further testing in two Phase Ib trials targeting individuals with diabetic macular oedema and Alzheimer’s disease.
Therini Bio CEO Tara Nickerson said: “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 the fundamental root causes of neurodegeneration.
“Galvanised 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 oedema.”
Based in California, Therini Bio develops immunotherapies to treat neuroinflammation in conditions where vascular dysfunction is a key driver.
The company’s pipeline includes therapies designed to selectively target toxic fibrin deposition, which is crucial for diseases such as Alzheimer’s and diabetic macular oedema.
