Minghui Pharma Reports Positive Phase Ib/II Results for MHB018A in Moderate-to-Severe TED

SHANGHAI, Oct. 22, 2024 /PRNewswire/ -- Minghui Pharmaceutical, Inc., a company focused on developing innovative treatments for immunological and oncological diseases, has announced promising results from its Phase Ib/II clinical trial of MHB018A in patients with active Thyroid Eye Disease (TED). MHB018A is a novel subcutaneous VHH-Fc fusion protein targeting the insulin-like growth factor-1 receptor (IGF-1R), a validated mechanism for treating TED.

In this multicenter, double-blind, randomized, placebo-controlled trial, the safety and preliminary effectiveness of MHB018A were evaluated in patients with active, moderate-to-severe TED. The trial tested three different dosing regimens: a 300 mg dose administered once every four weeks for three doses, a 450 mg dose given in the same manner, and a 600 mg initial dose followed by two 300 mg doses every four weeks. A total of 30 participants were enrolled, divided into the three dosing groups. Within each group, participants were randomly assigned in a 4:1 ratio to receive either MHB018A or a placebo via subcutaneous injection.

The results for the proptosis response rate (the percentage of participants achieving a reduction in proptosis of at least 2 mm from baseline) at week 12 were 50.0% for both the 300 mg and 600 mg+300 mg doses, and 87.5% for the 450 mg dose, compared to only 16.7% in the placebo group. Particularly noteworthy was the 450 mg group, where 50.0% of patients achieved a ≥2 mm reduction in proptosis at week 4, and 87.5% at week 8, demonstrating rapid, significant, and sustained responses.

Additional efficacy endpoints further supported the clinical benefits of MHB018A. These included the overall response rate, which is defined as the proportion of subjects achieving both a significant reduction in proptosis and an improvement of at least 2 points in the clinical activity score (CAS) in the study eye, as well as the proportion of subjects achieving a CAS of 0 or 1. Across all these parameters, MHB018A showed significant improvements compared to the placebo.

MHB018A was generally well-tolerated across all dosing regimens tested. Most adverse events reported were of Grade 1 or 2 severity and resolved after treatment completion without requiring intervention. Importantly, no severe hearing impairments were noted. The overall safety profile of MHB018A was consistent with other therapies targeting IGF-1R.

Guoqing Cao, Ph.D., Chief Executive Officer at Minghui Pharmaceutical, commented, "We are very encouraged by these findings, which highlight that subcutaneous administration of MHB018A offers rapid, deep, and durable responses in TED patients, especially at the 450 mg dose. The unique molecular structure and superior pharmacological characteristics of MHB018A are reflected in its promising efficacy and favorable safety results. Although these results are preliminary and based on a small cohort, they indicate significant potential. A subcutaneous treatment with a strong safety profile could represent a major advancement in TED management. Building on these positive results, we plan to start Phase 3 registrational trials in the first half of 2025."

Thyroid Eye Disease (TED) is an autoimmune condition characterized by the overactivation of orbital fibroblasts due to autoantibodies targeting thyroid receptors. The insulin-like growth factor 1 receptor (IGF-1R) is a key factor in the pathogenesis of TED and a validated target for effective treatment.

Minghui Pharmaceutical, founded in 2018, is a late-stage biopharmaceutical company dedicated to developing innovative therapies for unmet medical needs in oncology and autoimmune diseases. Utilizing medical expertise and proprietary technology platforms, the company is advancing a robust clinical-stage pipeline featuring a range of first-in-class or best-in-class product candidates.