South Korea-based clinical-stage biopharmaceutical company Kine Sciences announced on Friday that the first patient has been dosed in its Phase 1b/2a clinical study of KINE-101 for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
The company says that KINE-101, a novel nanopeptide and a disease modifier, controls both humoral immunity and cell-mediated immune responses by activating Treg cells. It received FDA approval for the Phase 1 study in September, 2021. The study was conducted in 40 healthy individuals in five cohorts assessed over 42 days. The design included four cohorts receiving intravenously administered ascending doses of KINE-101 (10, 30, 100 and 300 mg) and a cohort that received 96.8 mg of KINE-101 subcutaneously.
The Phase 1 study was completed successfully in October 2023, demonstrating a good safety profile. Beyond CIDP, KINE-101 is in development for additional indications, including Inflammatory Bowel Disease, Rheumatoid Arthritis and Non-Alcoholic Steatohepatitis.
Dae Ho Cho, PhD, chief executive officer, said: "Dosing the first patient marks our first programme in the clinic and represents an important milestone for our company. We look forward to the clinical data that will support the strong efficacy that we have seen in the preclinical studies. KINE-101 has a unique mechanism of action that targets what we believe is an underlying cause of the disease and differentiates it from symptomatic treatments. Moving forward, KINE-101 has the potential to offer more effective treatment options for CIDP patients either as a standalone therapy or in combination with existing treatments."
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