Kangpu Biopharmaceuticals to Present Results from Phase 2a of KPG-818 in SLE at EULAR 2024

HEFEI, China, June 10, 2024 /PRNewswire/ — Kangpu Biopharmaceuticals today announced that a poster tour presentation highlighting the Phase 2a clinical data of KPG-818 in patients with Systemic Lupus Erythematosus (SLE) will be presented at the upcoming Annual European Congress of Rheumatology EULAR 2024, taking place in Vienna, Austria, June 12-15, 2024.

Poster tour presentation details:

Abstract Title: KPG-818, a Novel Cereblon Modulator in Patients with Systemic Lupus Erythematosus: Results of a Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study
Abstract number: POS0057
Abstract authors: Robert Levin, et al.
Poster tour title: Clinical Poster Tours: Systemic lupus – Of old and new therapies
Poster tour date and time: Wednesday, June 12, 2024, 15:30 – 16:30 CEST
Poster tour location: Hall C

The Phase 2a trial is a multicenter, randomized, double-blind, placebo-controlled study, to assess the safety and tolerability, pharmacokinetics, and preliminary efficacy of KPG-818 in patients with SLE, and to select dosing regimens for Phase 2b study. Patients were randomized in a 1:1:1:1 ratio to receive KPG-818 capsules at doses of 0.15 mg, 0.6 mg, 2 mg, or placebo orally once daily for 12 weeks. Endpoints included baseline changes in activity scores of SLE disease activity index 2000 (SLEDAI-2K), cutaneous lupus erythematosus disease area and severity index (CLASI), physician global assessment (PGA).

The results showed that KPG-818 0.15 mg and 0.6 mg were generally well tolerated after 12 weeks of drug administration. Compared with placebo arm, 0.15 mg arm exhibited obvious improvements in SLEDAI-2K and CLASI scores at week 12. KPG-818 demonstrated a favorable pharmacokinetic profile, reduced the total B cell count and increased Treg in SLE patients.

SLE is a complex, heterogeneous, inflammatory, chronic auto-immune disease in which the body’s immune system attacks its own tissues. As reported by Frost & Sullivan, the global population of SLE patients is projected to grow to 8.6 million by 2030. As no small molecule drug was approved by the FDA for SLE in the last 60 years, there are huge unmet clinical needs. Dr. Robert W. Levin, the immediate past President of the Florida Society of Rheumatology and PI of this study, said: “KPG-818 demonstrated very promising preliminary efficacy, especially in SLE patients with cutaneous manifestation. There are tremendous unmet medical needs for more treatment options, especially an oral agent.”

Discovered by Kangpu Biopharmaceuticals and acting as molecular glue, KPG-818 is a modulator of Cereblon (CRBN) E3 ubiquitin ligase complex CRL4CRBN. The compound demonstrated potent degradation of Aiolos (IKZF3) and Ikaros (IKZF1). KPG-818 showed outstanding in vitro anti-inflammatory properties, broad spectrum of anti-proliferative activities, and remarkable in vivo efficacy in multiple blood cancer animal models. A bridge study (CTR20241116) for the treatment of SLE has been initiated in China. Meanwhile, a Phase 1 study of KPG-818 for the treatment of patients with hematological malignancies is being completed in the United States (NCT04283097).

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 autoimmune diseases, solid tumors, hematologic malignancies, and inflammatory disorders through novel solutions, including targeted protein ubiquitination and degradation. Kangpu has developed a robust pipeline of potential first-in-class and best-in-class drug candidates based on proprietary technology platforms, including NeoMIDES®, gDACs®, and X-SYNERGY®.

For more information, please visit www.KangpuGroup.com.

CONTACT: Florence Liu, wenjing.liu@kangpugroup.com

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