Kangpu Biopharmaceuticals, a clinical-stage company based in Hefei, China, announced the successful completion of a bridging clinical study of KPG-818 in healthy subjects in China. This randomized, double-blind, placebo-controlled study, designed to evaluate the safety and tolerability of KPG-818, included 30 participants who received various doses of the drug over a 14-day treatment period followed by a 4-week follow-up.
The study aimed to characterize the pharmacokinetics (PK) of KPG-818, which refers to how the drug is absorbed, distributed, metabolized, and eliminated from the body. This information is crucial for determining the optimal dosage regimens for future clinical trials.
The results of the study were positive. KPG-818 was well-tolerated in healthy subjects, with no serious adverse events reported. The most common side effects were mild itching or rash. Importantly, the study revealed a near-linear relationship between the dose of KPG-818 and its concentration in the body, suggesting predictable and consistent drug exposure.
KPG-818 is a small molecule modulator of the CRBN E3 ubiquitin ligase complex CRL4-CRBN. This unique mechanism of action makes it a promising candidate for treating various autoimmune diseases. In a previous Phase Ib/IIa clinical study conducted in the United States, KPG-818 demonstrated promising efficacy in treating Systemic Lupus Erythematosus (SLE) patients, while also exhibiting a favorable safety and tolerability profile.
Kangpu Biopharmaceuticals is a leading company focused on the discovery and development of innovative molecular glue-based therapeutics for treating autoimmune diseases, solid tumors, hematologic malignancies, and inflammatory disorders. They have developed a robust pipeline of potential first-in-class and best-in-class drug candidates based on their proprietary technology platforms.
The successful completion of this bridging clinical study in China marks a significant milestone for Kangpu Biopharmaceuticals. It provides valuable data for future clinical trials in China, bringing them closer to developing KPG-818 as a potentially life-changing treatment for patients suffering from autoimmune diseases.
