Kangpu Biopharmaceuticals Successfully Completed Phase I Study of Novel CRL4-CRBN Modulator KPG-818 in the U.S.

SHANGHAI,Oct. 11,2019 -- Kangpu Biopharmaceuticals announced today that it has successfully completed a first-in-human phase I single ascending dose (SAD) clinical study of KPG-818 conducted in the United States.

This randomized,double-blind,placebo-controlled study evaluated the safety,tolerability and pharmacokinetics (PK) of KPG-818 in healthy male and female participants following oral administration. A total of 40 subjects were randomized to receive active drug or placebo in a double-blind fashion (8 subjects in each dose cohort,6 subjects randomized to receive active drug and 2 subjects randomized to receive placebo). Five dose levels (2,5,10,20 and 30 mg) were investigated.

In the completed phase I study,there were no safety or tolerability concerns. No serious adverse events (SAE) were reported at any dose level studied. No stopping criteria were met. KPG-818 was well tolerated at all tested dose levels. KPG-818 also demonstrated a favorable pharmacokinetic profile supporting once-daily oral dosing. The phase I results also revealed that dosing under fed conditions does not have significant influence on the exposure of KPG-818 as compared to fasted conditions.

The study results will assist Kangpu Biopharmaceuticals in identifying appropriate doses of KPG-818 that can be administered in subsequent clinical trials in patients with systemic lupus erythematosus (SLE) or hematological malignancies.

About KPG-818

KPG-818 is a novel small molecule modulator of the CRBN E3 ubiquitin ligase complex CRL4-CRBN. In preclinical studies,KPG-818 demonstrated outstanding in vitro anti-inflammatory and anti-proliferative properties as well as remarkable in vivo efficacy in myeloma and lymphoma animal models. KPG-818 is currently being developed by Kangpu Biopharmaceuticals for the treatment of SLE and hematological malignancies.

About Kangpu Biopharmaceuticals

Headquartered in Zhangjiang Hi-Tech Park,Shanghai,China,Kangpu Biopharmaceuticals,Ltd. is a clinical-stage company focused on the discovery and development of innovative small molecules for the treatments of solid tumors,hematological malignancies,auto-immune diseases as well as inflammatory disorders through novel-generation solutions including targeted protein ubiquitination and degradation. The company has developed the X-SynergyTM platform,a proprietary drug combination technology for the treatment of castration-resistant prostate cancer (CRPC/mCRPC). Kangpu is committed to outstanding sciences to develop novel and effective medicines that address significant unmet medical needs worldwide.

View original content to download multimedia:/news-releases/kangpu-biopharmaceuticals-successfully-completed-phase-i-study-of-novel-crl4-crbn-modulator-kpg-818-in-the-us-300937030.html