Kangpu Biopharma to Present Phase 2a KPG-818 SLE Results at EULAR 2024

Kangpu Biopharmaceuticals recently unveiled the results of their Phase 2a clinical trial for KPG-818, targeting Systemic Lupus Erythematosus (SLE). This data will be highlighted at the Annual European Congress of Rheumatology, EULAR 2024, in Vienna, Austria, from June 12-15, 2024.

The presentation, led by Robert Levin and colleagues, is titled "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). The poster tour, named "Clinical Poster Tours: Systemic lupus - Of old and new therapies," will take place on June 12, 2024, from 15:30 to 16:30 CEST in Hall C.

The trial was a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of KPG-818 in SLE patients, as well as to determine dosing regimens for subsequent Phase 2b studies. Patients were assigned to one of four groups in a 1:1:1:1 ratio, receiving either 0.15 mg, 0.6 mg, 2 mg of KPG-818, or a placebo, orally once a day for 12 weeks. The primary endpoints included changes in the SLE disease activity index 2000 (SLEDAI-2K), cutaneous lupus erythematosus disease area and severity index (CLASI), and physician global assessment (PGA) scores from baseline.

The findings indicated that the 0.15 mg and 0.6 mg doses of KPG-818 were generally well tolerated over the 12-week period. Particularly, the 0.15 mg dose showed significant improvements in SLEDAI-2K and CLASI scores compared to the placebo. KPG-818 also exhibited a favorable pharmacokinetic profile, reduced total B cell counts, and increased regulatory T cells (Treg) in SLE patients.

SLE is a chronic autoimmune disease characterized by the immune system attacking the body's tissues. According to Frost & Sullivan, the global SLE patient population is expected to reach 8.6 million by 2030. Despite the growing need, no small molecule drug has been approved by the FDA for SLE in the last 60 years, creating a significant unmet clinical demand. Dr. Robert W. Levin, the immediate past President of the Florida Society of Rheumatology, and Principal Investigator of the study, commented on the promising efficacy of KPG-818, particularly for patients with cutaneous manifestations, emphasizing the necessity for more oral treatment options.

KPG-818, developed by Kangpu Biopharmaceuticals, acts as a molecular glue modulating the Cereblon (CRBN) E3 ubiquitin ligase complex CRL4CRBN. It has shown effective degradation of Aiolos (IKZF3) and Ikaros (IKZF1), demonstrating potent in vitro anti-inflammatory properties, broad anti-proliferative activities, and notable in vivo efficacy in multiple blood cancer animal models. A bridge study (CTR20241116) is underway in China for SLE treatment, and a Phase 1 study for hematological malignancies is nearing completion in the United States (NCT04283097).

Kangpu Biopharmaceuticals is a clinical-stage company specializing in the discovery and development of innovative small molecules to treat autoimmune diseases, solid tumors, hematologic malignancies, and inflammatory disorders. Their drug development pipeline includes potential first-in-class and best-in-class candidates based on proprietary platforms such as NeoMIDES®, gDACs®, and X-SYNERGY®.