Chinese pharmaceutical company Kangpu Biopharmaceuticals Ltd announced on Monday that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved a Phase IIb clinical trial of its KPG-818 capsule for the treatment of moderate to severe cutaneous manifestations of systemic lupus erythematosus (SLE).

KPG-818 is a novel oral molecular glue modulator of the E3 ubiquitin ligase complex CRL4-CRBN. The company says that it demonstrated high binding affinity to CRBN and potent degradation of zinc-finger transcription factors Aiolos (IKZF3) and Ikaros (IKZF1). KPG-818 effectively regulates immune cells (B cells, T cells and pDC cells) and the release of multiple cytokines, possessing immunomodulatory, anti-angiogenic and anti-tumour effects.

In the Phase IIa clinical study in SLE patients completed in the United States, KPG-818 was well tolerated and demonstrated promising preliminary efficacy in SLE patients with cutaneous manifestations. KPG-818 was also well tolerated in healthy subjects in a Phase I clinical study completed in China.