MHB018A / Minghui Pharma - LARVOL DELTA

Open-Label Extension Study of MHB018A in Subjects With Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=258 | Not yet recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd

New P3 trial • Ophthalmology • Thyroid Eye Disease

Interventional: MHB018A Treatment in Patients With Chronic Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd

New P3 trial • Ophthalmology • Thyroid Eye Disease

MHB018A Treatment in Patients With Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=108 | Recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Ophthalmology • Thyroid Eye Disease

Subcutaneous MHB018A, a novel IGF-1R VHH-Fc Antibody, for Thyroid Eye Disease (TED): Results from a Phase 1/2 Study in Patients with Active and Chronic TED [WITHDRAWN] (ATA 2025) - No abstract available

Clinical • Late-breaking abstract • P1/2 data • Ophthalmology • Thyroid Eye Disease

MHB018A Treatment in Patients With Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=108 | Not yet recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd

New P3 trial • Ophthalmology • Thyroid Eye Disease

Minghui Pharmaceutical Inc. Announces Positive Topline Results from Phase Ib/II Clinical Trial of MHB018A, a Subcutaneous Single-Domain IGF-1R Antibody, in Patients with Active, Moderate-to-Severe Thyroid Eye Disease (TED) (PRNewswire) - P1/2 | N=30 | "Minghui Pharmaceutical, Inc...announced positive topline results from its Phase Ib/II clinical trial of MHB018A in patients with active TED....The proptosis response rate (the percentage of participants who achieves a reduction in proptosis of ≥2 mm compared to baseline) at week 12 for the study eye was 50.0%, 50.0% and 87.5% for the 300 mg, 600 mg+300 mg and 450 mg groups, respectively, compared to 16.7% in the placebo group (See table below). The 450 mg group demonstrated rapid, profound, and sustained responses, with 50.0% (4/8) and 87.5% (7/8) of patients achieving a ≥2 mm reduction in proptosis at week 4 and 8, respectively....'Building on these encouraging results, we plan to initiate Phase 3 registrational trials in the first half of 2025.'"

New P3 trial • P1/2 data • Thyroid Eye Disease