Kangpu Biopharmaceuticals has announced the completion of a bridging clinical study of KPG-818 in China.
The double-blind, randomised, placebo-controlled, trial enrolled healthy subjects to assess the safety and tolerability of the varying oral doses of the asset.
Go deeper with GlobalData
It also examined the food effects on the pharmacokinetics of KPG-818.
The trial enrolled both male and female healthy participants who were given KPG-818 over a 14-day treatment period, followed by a four-week follow-up.
It included a total of 30 participants who were divided into three escalating cohorts, with doses ranging from 0.15mg to 2mg, and a separate cohort examined the effects of food on a 0.6mg dose.
According to the findings, KPG-818 demonstrated to have a favourable safety profile without any serious adverse events reported.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe most common adverse events were grades 1-2 pruritus or rash.
The pharmacokinetics of KPG-818 showed close to linear behaviour within the dosing range, and food intake did not significantly alter the drug’s exposure.
KPG-818 is designed as a small molecule modulator of the CRBN E3 ubiquitin ligase complex CRL4-CRBN.
The asset showed promising results in a Phase Ib/IIa study in systemic lupus erythematosus (SLE) patients in the US.
In March 2023, Kangpu completed participant enrolment for the Phase IIa trial of KPG-818 to treat SLE, a complex, heterogeneous, inflammatory, chronic auto-immune disease, in the US.
According to the findings, 0.15mg and 0.6mg doses of KPG-818 were generally well tolerated following 12 weeks of dosing.
Compared to the placebo group, the 0.15mg group demonstrated improvements in SLEDAI-2K and CLASI scores at week 12.
The double-blind, multicentre, placebo-controlled, randomised trial was designed to assess the pharmacokinetics, tolerability, preliminary efficacy, and safety of KPG-818 in SLE patients.
