THN391 / Therini Bio - LARVOL DELTA

Therini Bio Raises Additional $39M Series A Financing to Advance Clinical Development of Neurodegenerative Disease Pipeline (GlobeNewswire) - "Therini Bio anticipates using the proceeds to fund Phase 1b trials evaluating its lead candidate, THN391, for the treatment of Alzheimer’s Disease (AD) and Diabetic Macular Edema (DME), as well as support development of a fibrin/VEGF bispecific."

Financing • Alzheimer's Disease • Diabetic Macular Edema

Therini Bio Announces Positive Phase 1a Trial Results Evaluating THN391 for Neurodegenerative Diseases (GlobeNewswire) - P1a | N=NA | "Therini Bio, Inc...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 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....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."

P1 data • Trial status • Alzheimer's Disease • Diabetic Macular Edema

THN391 – a novel anti-fibrin antibody, evaluated in an ongoing phase 1b study for the treatment of diabetic macular edema (ARVO 2025) - "THN391 is a novel anti-fibrin antibody for the treatment of retinal diseases. It is being evaluated in a Phase 1b trial for diabetic macular edema."

P1 data • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • ITGAM • ITGAX

A Study to Assess THN391 in Subjects with Alzheimer's Disease (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: Therini Bio, Inc.

New P1 trial • Alzheimer's Disease • CNS Disorders

A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy. (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Therini Bio Pty Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetic Macular Edema • Diabetic Retinopathy • Macular Edema • Ophthalmology • Retinal Disorders

A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy. (clinicaltrials.gov) - P1 | N=21 | Not yet recruiting | Sponsor: Therini Bio Pty Ltd

New P1 trial • Diabetic Macular Edema • Diabetic Retinopathy • Macular Edema • Ophthalmology • Retinal Disorders

A Novel Anti-Fibrin Antibody to Treat Neurodegenerative Ocular Diseases (ARVO 2024) - "On Day 7 and Day 14, THN391 and control VEGF antagonists (aflibercept and bevacizumab) significantly reduced lesion permeability. Our results support further clinical development of THN391 to treat neurodegenerative ocular diseases. The role of macrophages may contribute to the resistance and/or loss of efficacy of the VEGF antagonists in retinal diseases. TH391 alone, or in combination with VEGF antagonists, has the potential to treat these diseases and overcome a key resistance mechanism."

Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Ocular Inflammation • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • ITGAM • ITGAX

Fibrin-Targeting Immunotherapy for Dementia. (PubMed, J Prev Alzheimers Dis) - "THN391 is a humanized, affinity-matured antibody which has a 100-fold greater affinity for fibrin P2 and improved development properties compared to the parental 5B8 antibody. It is currently in a Phase 1 clinical trial."

Journal • Alzheimer's Disease • CNS Disorders • Dementia • Inflammation • Multiple Sclerosis • ITGAM • ITGAX

Translation Studies and Clinical Development of THN391, a Novel Anti-Fibrin Antibody for the Treatment of Dementia (CTAD 2023) - "THN391 specifically targets the P2 epitope on fibrin, blocking activation of innate immune cells. This activity prevents disease progression in multiple models of Neuroinflammation. These models have helped to identify potential fluid biomarkers for translation to the clinic."

Clinical • Alzheimer's Disease • Cardiovascular • CNS Disorders • Dementia • Inflammation • Multiple Sclerosis • Thrombosis • IL12A • IL1B • IL6 • ITGAM • ITGAX • ITGB2

Therini Bio Announces Interim Results from the Phase 1 Trial of THN391 for the Potential Treatment of Dementia (GlobeNewswire) - "Therini Bio, Inc...announced interim results from the Phase 1 trial of its lead candidate, THN391, for the treatment of dementia....At the data cut-off date, the first three cohorts (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg) of eight subjects each (n=24) had received a single dose of THN391. No drug related adverse events were reported and the therapy was found to be well-tolerated. In addition, dose proportional Cmax levels were observed. Data from the first two cohorts, 0.3 mg/kg and 1.0 mg/kg, demonstrated a half-life of approximately 50 days in both groups. Data from the 3.0 mg/kg cohort continues to mature and additional SAD 10 mg/kg and MAD 3.0 mg/kg cohorts have been initiated."

P1 data • PK/PD data • CNS Disorders • Dementia

Therini Bio Initiates First-In-Human Dosing in Phase 1 Trial of THN391, a Fibrin-Targeting Therapeutic Candidate for Alzheimer’s Disease (Businesswire) - "Therini Bio, Inc...today announced the initiation of first-in-human dosing for a Phase 1 trial of its lead asset THN391, a fibrin-targeting therapeutic candidate for Alzheimer’s disease....Key safety and proof of mechanism clinical data is expected by the end of 2024."

P1 data • Trial status • Alzheimer's Disease • CNS Disorders

Therini Bio Initiates First-In-Human Dosing in Phase 1 Trial of THN391, a Fibrin-Targeting Therapeutic Candidate for Alzheimer’s Disease (Businesswire) - "Therini Bio...today announced the initiation of first-in-human dosing for a Phase 1 trial of its lead asset THN391, a fibrin-targeting therapeutic candidate for Alzheimer’s disease....Key safety and proof of mechanism clinical data is expected by the end of 2024."

Trial status • Alzheimer's Disease • CNS Disorders

A startup taking a different approach to Alzheimer’s gets fresh funds, Lilly backing (BioPharma Dive) - "'We think of it as a funnel with all of these contributing factors ultimately resulting in neuronal cell dysfunction and death,' said Howard Fillit....'If we can engage the neuroprotective pathways of the cell in the face of all these many injury pathways, we might be able to have a therapeutic effect.'"

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