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

09:00 EDT 11 Oct 2019 | PR Newswire

SHANGHAI, Oct. 11, 2019 /PRNewswire/ -- 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.

Cision View original content to download multimedia:

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


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

Quick Search

Relevant Topics

Biotechnology Products
BioPortfolio lists over 550 biotechnology products - please open Direct topic pages: Actos Advair Biopharmaceuticals Biosimilars Biotherapeutics GMO Crops Lipitor ...

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...