Therini Bio Doses First Patients in Phase 1b Trial of Novel Anti-Inflammatory Therapy, THN391, for Diabetic Macular Edema
Company also advances fibrin/VEGF bispecific antibody THN622, a potential new standard of care for retinal neurodegeneration
SACRAMENTO, Calif., May 27, 2026 (GLOBE NEWSWIRE) -- Therini Bio, Inc., a clinical-stage biotech company developing fibrin-targeting immunotherapies for neurodegenerative diseases driven by vascular-mediated inflammation, today announced that the first patients have been dosed in a Phase 1b trial evaluating THN391 for the treatment of Diabetic Macular Edema (DME) and provided an update on its ophthalmology program, including lead candidate selection of a fibrin/VEGF bispecific, THN622.
In DME, loss of vascular integrity leads to the accumulation of toxic fibrin deposits and induces chronic neuroinflammation, resulting in neuro-retinal degeneration. THN391 is a potential first-in-class, high-affinity, humanized monoclonal antibody designed to selectively block fibrin’s inflammatory epitope and halt the neuroinflammation cascade without disrupting coagulation. In a recently published paper in the Journal of Neuroinflammation (Kantor et al., 2026), Therini demonstrated that THN391 was as effective as VEGF antagonists in containing leakage from neovascular lesions in preclinical models.
The ongoing Phase 1b multiple ascending dose study will assess the safety and preliminary efficacy of THN391 in patients with DME. The trial is designed to include three dose cohorts with each patient receiving three monthly intravitreal injections. In addition to safety, biological activity will be assessed using measures including retinal central subfield thickness, visual acuity and exploratory biomarkers. Initial data is expected in 4Q 2026.
Joel Naor, M.D., M.B.A., MSc., Chief Medical Officer – Ophthalmology of Therini Bio, a seasoned leader in retinal therapeutics development, whose previous experience includes leadership roles at Opthea, Kodiak Sciences, Santen, Macusight, Allergan and QLT, said, “The dosing of the first cohort of patients in our THN391 trial represents a significant milestone for Therini Bio. By targeting fibrin-driven inflammation, THN391 has the potential to enhance retinal health, improve treatment outcomes, and preserve vision in patients with DME. We look forward to evaluating the results of this trial and advancing THN622 toward the clinic.”
THN622 is a bispecific anti-fibrin inflammatory epitope and anti-VEGF blocking antibody in development to treat retinal conditions characterized by vascular dysfunction, including DME. The dual mechanism of action combines the current standard of care, responsible for treating VEGF-mediated leakage, with a novel fibrin blocker intended to prevent the underlying neuroinflammation. The combination of the two may potentially increase treatment efficacy, increase overall response rates, increase durability, prevent fibrosis and emerge as the new standard for the treatment of neurodegenerative ocular diseases.
About
Therini Bio is a clinical-stage biotech company developing immunotherapies for vascular-mediated inflammation with a focus on neuroinflammation in diseases driven by vascular dysfunction. Therini Bio is developing a pipeline of potential first-in-class therapies selectively targeting fibrin-mediated inflammation for diseases, including Alzheimer’s disease and Diabetic Macular Edema, where vascular-mediated inflammation 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, Angelini Ventures, Apollo Health Ventures, SV Health Investors’ Biotech Fund and Dementia Discovery Fund, Dolby Family Ventures, Dreavent Biotech Investments, Eli Lilly and Company, Foundation for a Better World, Mitsui Global Investment, 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
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