Kangpu Biopharma Successfully Completes Phase I Clinical Trial of KPG-818 in Healthy Volunteers in the United States

On October 11, VCBeat learned that Kangpu Biomedical Technology (Shanghai) Co., Ltd. (“Kangpu Biomedical”) announced the successful completion of its Phase I clinical study of the Class I innovative drug KPG-818 in healthy subjects in the United States. This randomized, double-blind, placebo-controlled clinical trial was primarily designed to evaluate the safety, tolerability, and pharmacokinetic profile of KPG-818 in healthy subjects.

A total of 40 healthy subjects participated in this study, which comprised five oral single ascending dose (SAD) cohorts (2, 5, 10, 20, and 30 mg). Each cohort enrolled eight subjects, with six receiving the investigational drug and two receiving placebo. The clinical trial achieved its primary objectives; no serious adverse events (SAEs) were reported, and the maximum tolerated dose was not reached. KPG-818 demonstrated favorable safety and tolerability within the dose range up to 30 mg.

Pharmacokinetic data from clinical studies showed that KPG-818 was rapidly absorbed in healthy subjects, with half-lives ranging from 11 to 24 hours across the five dose groups. Both AUC and Cmax demonstrated a good linear relationship with the administered dose. Furthermore, food had no significant effect on pharmacokinetics. The favorable safety and tolerability profile, along with the pharmacokinetic parameters obtained from clinical trials, have laid a solid foundation for Kangpu Biomedical to advance KPG-818 into further clinical studies for the treatment of systemic lupus erythematosus and various hematologic malignancies.

KPG-818 is a next-generation oral small-molecule immunomodulatory drug, independently developed by Kangpu Biomedical with global intellectual property rights. It belongs to the class of CRL4-CRBN (Cullin-RING E3 ubiquitin ligase complex) modulators. Preclinical study data indicate that KPG-818 can effectively downregulate the expression levels of cytokines such as IL-6 and TNF-α, and efficiently degrade the zinc finger transcription factors Ikaros (IKZF1) and Aiolos (IKZF3). In preclinical trials, KPG-818 demonstrated favorable GLP toxicological tolerance and pharmacokinetic properties suitable for drug development, and exhibited superior therapeutic efficacy in various animal models of hematologic malignancies.

Founded in 2011 and headquartered in Zhangjiang High-Tech Park, Shanghai, Kangpu Biomedical is a clinical-stage innovative biopharmaceutical company. The company boasts a seasoned expert team and operational team with robust capabilities, international vision, and extensive industry experience in innovative drug development. Driven by innovation and focused on therapeutic areas such as cancer, autoimmune diseases, and inflammation, Kangpu Biomedical leverages its proprietary patented technologies, including the internationally leading next-generation protein ubiquitination and degradation platform and the X-Synergy® novel drug combination technology platform. The company is dedicated to developing global, first-in-class small-molecule targeted immunomodulatory innovative drugs with independent global intellectual property rights. Kangpu Biomedical’s overall strategic goal is to establish a modern biopharmaceutical enterprise integrating research and development, manufacturing, and sales. It remains committed to providing patients with first-in-class or best-in-class therapeutic solutions, addressing urgent and unmet clinical needs, and contributing to the conquest of disease and the enhancement of human health and well-being.