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The phase 1b/2a dose escalation trial of KINE-101, conducted in Korea, includes patients with chronic inflammatory demyelinating polyneuropathy who have received at least 1 frontline treatment regimen.
According to a recent company announcement, the first patient has been dosed in Kine Sciences’ phase 1b/2a study assessing KINE-101, a novel nanopeptide, for chronic inflammatory demyelinating polyneuropathy (CIDP).1 The investigational agent is disease modifier treatment that aims to control both humoral immunity and cell-mediated immune responses by activating Treg cells.
"Dosing the first patient marks our first programme in the clinic and represents an important milestone for our company," Dae Ho Cho, PhD, chief executive officer at Kine Sciences, said in a statement.1 "We look forward to the clinical data that will support the strong efficacy that we have seen in the preclinical studies.”
In September 2021, the company announced that the FDA cleared KINE-101 for its phase I study, which assessed the treatment over a 42-day treatment period in 40 healthy patients across 5 cohorts. The study design included 4 cohorts who received intravenously administered ascending doses of KINE-101 (10-mg, 30-mg, 100-mg, and 300-mg), and a subcutaneous cohort that received 96.8-mg of KINE-101. Kine Sciences noted that the phase 1 study was completed successfully in October 2023 and showed positive safety findings.
The company noted that its KINE-101 agent is the first ever CIDP-specific therapy developed for disease-specific mechanism of action. Currently, the treatment is undergoing domestic clinical trials targeting Korean patients with CIDP and is also in development for additional conditions, such as inflammatory bowel disease, rheumatoid arthritis and non-alcoholic steatohepatitis.
“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,” Ho Cho said in a statement.1
Additional news in CIDP, according to a recently published study, showed that patients with clinical and supportive features of the condition lacking nerve conduction studies (NCS) evidence of demyelination had a positive treatment response to immunomodulatory therapies. Overall, these data raise the consideration of a trial testing an immunomodulating treatment in this patient population, especially when there is MRI lumbosacral root or plexus enhancement.3,4
Published in Muscle & Nerve, 232 patients were assessed and treated for presumed CIDP, of whom 20 met all criteria for the study. In follow-up, 12 patients had a sustained positive treatment response by Medical Research Council sum score (MRCSS) or modified Rankin scale (mRS). Of these, 7 patients met the criteria for improvement in either scale at the 3-month follow-up visit, 1 at 6 months, 3 at 12 months, and 1 at 2 years.
Authors defined a positive treatment response from the disease modifying therapies given to participants as at least a 1-point improvement in the mRS, or a 4-point increase in the MRCSS. Researchers had data collected at baseline pre-treatment and then post treatment at 3 months, 6 months, 1 year, and each year after until the last follow-up visit.
Authors observed no clinical features associated with a positive clinical response. Of the supportive laboratory features, investigators reported that only MRI nerve root enhancement was associated with a positive treatment response on the MRCSS or mRS in the participants. Additionally, neither the presence of enlarged proximal nerves on US nor an elevated CSF protein greater than 45 mg/dL or even greater than 100 mg/dL was reported as associated with a positive treatment response. Among the 6 patients with contrast enhancement on MRI, 4 met criteria for polyradicular CIDP, and 2 had multifocal presentations with lumbar or brachial plexus involvement, 1 of which had a confirmatory brachial plexus fascicular nerve biopsy.
