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.
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial