Kangpu Biopharmaceuticals has completed participant enrolment for the Phase IIa clinical trial of KPG-818 to treat systemic lupus erythematosus (SLE), a complex, heterogeneous, inflammatory, chronic auto-immune disease, in the US.
The double-blind, multicentre, placebo-controlled, randomised Phase IIa trial has been designed for evaluating the pharmacokinetics, tolerability, preliminary efficacy, and safety of KPG-818 in SLE patients.
In the trial, participants are randomised into a 1:1:1:1 ratio to receive 0.15mg, 0.6mg, or 2mg doses of KPG-818 capsules or a placebo orally, once-a-day, for 12 weeks. The first participant in the trial was dosed in June last year.
Physician global assessment (PGA), baseline changes in activity scores of systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K), PK and PD parameters, incidence and severity of adverse events (AEs), cutaneous lupus erythematosus disease area and severity index (CLASI), and tender and swollen joint counts are some of the trial’s clinical endpoints.
KPG-818 is a new generation of small molecule CRBN E3 ubiquitin ligase complex CRL4-CRBN modulators.
It was found to be well tolerated at all tested dose levels and showed a favourable pharmacokinetic profile in the first-in-human Phase Ia single ascending dose (SAD) clinical trial and the Phase Ib clinical trial conducted in SLE patients in the US.
Kangpu Biopharmaceuticals chief medical officer Yao WANG said: “We are delighted to see the completion of patient enrolment for the Phase IIa study, which marks a significant advancement in the study of KPG-818.
“Both Phase Ia and Ib clinical trials in the US have demonstrated KPG-818’s good safety and tolerability.
“We hope that KPG-818 can provide an effective new treatment option for patients and address the urgent unmet medical treatment for this disease around the world.”