Kangpu Biopharmaceuticals, a China-based clinical-stage company, has started a Phase Ib/IIa clinical study of KPG-818 in patients with Systemic Lupus Erythematosus (SLE) after consulting with the United States Food and Drug Administration (FDA), it was reported on Tuesday.
The Phase Ib/IIa multicentre, randomised, double-blind, placebo-controlled clinical study is to assess the safety and tolerability, pharmacokinetics and preliminary efficacy of the product in patients with mild to moderate SLE.
KPG-818 is a novel generation of small molecule modulators of the CRBN E3 ubiquitin ligase complex CRL4-CRBN and potently induces the ubiquitination and degradation of Aiolos (IKZF3) and Ikaros (IKZF1), two members of the Ikaros family of zinc-finger transcription factors critical in B-cell development.
In preclinical studies, KPG-818 demonstrated outstanding in vitro anti-inflammatory properties and broad spectrum of anti-proliferative activities as well as remarkable in vivo efficacy in animal models of multiple blood cancers.
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