Kangpu Completes Bridging Study of KPG-818 in China

HEFEI, China, Sept. 20, 2024 /PRNewswire/ -- Kangpu Biopharmaceuticals, a clinical-stage company based in Hefei, China, announced the successful completion of a bridging clinical study for KPG-818 in healthy subjects within the country.

This randomized, double-blind, placebo-controlled study incorporated food effects (FE) to evaluate the safety and tolerability of multiple oral doses of KPG-818 in healthy male and female participants. The study involved a treatment duration of 14 days followed by a 4-week follow-up period. The primary aims were to characterize the pharmacokinetics (PK) of single and multiple oral doses of KPG-818 and to determine optimal dosing regimens for future clinical trials.

A total of 30 participants were randomized into three escalating dose groups, with each group consisting of 10 individuals (8 receiving KPG-818 and 2 receiving a placebo). The doses administered were 0.15 mg, 0.6 mg, and 2 mg, taken once daily. Additionally, a food effects cohort of 12 participants received a single 0.6 mg dose of KPG-818 both with and without food to evaluate any potential dietary impact on the drug's efficacy.

The study results indicate that KPG-818 is well tolerated among healthy subjects, with no serious adverse events (SAEs) reported. The most commonly observed adverse events (AEs) were mild to moderate pruritus or rash. Furthermore, the pharmacokinetics of KPG-818 appeared nearly linear across the tested dose range of 0.15 mg to 2 mg. The study also showed consistent drug exposure levels whether participants were in fed or fasted conditions.

KPG-818 is identified as a small molecule modulator of the CRBN E3 ubiquitin ligase complex CRL4-CRBN. In previous Phase Ib/IIa clinical studies conducted in the United States on patients with systemic lupus erythematosus (SLE), identified by the trial ID NCT04643067, KPG-818 demonstrated promising efficacy coupled with a favorable safety and tolerability profile.

Kangpu Biopharmaceuticals specializes in the discovery and development of innovative molecular glue-based therapeutics aimed at treating autoimmune diseases, solid tumors, hematologic malignancies, and inflammatory disorders. The company has developed a strong pipeline of potential first-in-class and best-in-class drug candidates utilizing their proprietary technology platforms, including NeoMIDES®, gDACS®, and X-SYNERGY®.