HEFEI,
China, Sept. 20, 2024 /PRNewswire/ -- Kangpu
Biopharmaceuticals, a clinical-stage company based in Hefei, China, announced today that the Company
has successfully completed a bridging clinical study of KPG-818 in
healthy subjects in China.
The randomized, double-blind, placebo-controlled, and food
effects (FE) study aimed to assess the safety and tolerability of
multiple oral doses of KPG-818 in male and female healthy
participants over a treatment period of 14 days and a follow-up
period of 4 weeks, to characterize the single and multiple oral
dose pharmacokinetics (PK) of KPG-818, and to select dosing
regimens of KPG-818 for future clinical trials. A total of 30
participants were randomized to three escalating cohorts (n=10
each; 8 KPG-818, 2 placebo) receiving 0.15 mg, 0.6 mg, 2 mg or
placebo once daily. In the FE cohort, 12 participants received
single dose of 0.6 mg KPG-818 with and without food.
KPG-818 is well tolerated in healthy subjects. No serious
adverse events (SAEs) were reported. The most common AEs were
grades 1-2 of pruritus or rash.
Close to linear PK of KPG-818 was observed in the dosing range
of 0.15 mg-2 mg. Similar exposure was observed for KPG-818
under fed/fasted conditions.
KPG-818 is a small molecule modulator of CRBN E3 ubiquitin
ligase complex CRL4-CRBN. In the Phase Ib/IIa clinical study in SLE
patients (trial ID: NCT04643067) completed in the US, KPG-818
demonstrated promising efficacy and a favorable safety and tolerability
profile.
About Kangpu Biopharmaceuticals
Kangpu Biopharmaceuticals, Ltd. is a clinical-stage company
focused on the discovery and development of innovative molecular
glue-based therapeutics for the treatment of autoimmune diseases,
solid tumors, hematologic malignancies and inflammatory disorders.
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
Media Contact: Florence Liu,
wenjing.liu@kangpugroup.com
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SOURCE Kangpu Biopharmaceuticals