Shanghai, China, Nov 16, 2020 -- Kangpu Biopharmaceuticals, a clinical-stage company based in Shanghai, China, announced today that, after consulting with the U.S. Food and Drug Administration (FDA), the Company has initiated a Phase Ib/IIa clinical study of KPG-818 in patients with Systemic Lupus Erythematosus (SLE).
The Phase Ib/IIa multicenter, randomized, double-blind, placebo-controlled clinical study will evaluate the safety and tolerability, pharmacokinetics and preliminary efficacy of KPG-818 in patients with mild to moderate SLE.
About Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erythematosus (SLE) is a complex, heterogeneous, inflammatory, chronic auto-immune disease in which the body’s immune system attacks its own tissues, leading to widespread damage in various organs, including the kidneys, lungs, heart, brain, skin, joints, and blood vessels. As reported by Frost & Sullivan, there were approximately 7.7 million SLE patients in 2019 worldwide. In over 60 years, only one new treatment (Benlysta) has been approved for SLE by the FDA. With limited clinical treatment options available and no cure for the disease, effective management of SLE remains a huge challenge.
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. In the Phase I single ascending dose (SAD) clinical study recently completed in the U.S., KPG-818 was well tolerated at all tested dose levels (2-30 mg) and demonstrated a favorable pharmacokinetic profile. KPG-818 is currently being developed in a Phase I study for the treatment of patients with hematological malignancies in the United States (NCT04283097 at www.clinicaltrials.gov). In addition, KPG-818 has recently been approved by the FDA for a Phase IIa clinical trial in patients with COVID-19 infection in the U.S.
About Kangpu Biopharmaceuticals
Kangpu Biopharmaceuticals, Ltd. is a clinical-stage company focused on the discovery and development of innovative small molecules for the treatment of solid tumors, hematological malignancies, auto-immune diseases as well as inflammatory disorders through novel-generation solutions including targeted protein ubiquitination and degradation. Led by a highly experienced and dedicated management team, Kangpu has built a rich and solid pipeline of potential first-in-class and best-in-class drug candidates. The company has also developed X-Synergy®, a proprietary drug combination technology for the treatment of metastatic and non-metastatic castration-resistant prostate cancer.
For more information, please visit www.KangpuGroup.com.
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