[Asia Economy Reporter Chunhee Lee] Neural Science announced on the 26th that it has officially completed Phase 1 clinical trials in Canada for 'NS101,' a synapse-related antibody new drug under development as a treatment for neurological disorders.
This clinical trial was conducted in Canada as a randomized, placebo-controlled, single-dose dose-escalation study. It involved 64 healthy adult volunteers divided into eight cohorts, ranging from the minimum dose (0.25 mg/kg) to the maximum dose (48 mg/kg). NS101 was administered intravenously through sequential dose escalation. The subjects were then followed up for two months to evaluate safety, tolerability, pharmacokinetics, and immunogenicity.
As a result, NS101 was proven to be safe compared to the placebo group. There were no statistically significant differences in safety indicators such as adverse reactions, vital signs, local injection site reactions, physical examinations, and laboratory test results compared to the placebo group. There were no serious adverse events (SAEs) or dropouts due to adverse reactions during the clinical trial period. The pharmacokinetic characteristics in the blood showed expected results, and pharmacokinetic measurements in cerebrospinal fluid demonstrated that NS101 appropriately targeted the central nervous system.
NS101 selectively acts on target proteins to promote synapse formation, preventing neuronal cell death and degeneration. Consequently, it induces recovery of cognitive, motor, and sensory functions through neuronal cell recovery and regeneration.
Sung Jaeyoung, CEO of Neural Science, stated, “The results of this Phase 1 clinical trial in Canada indicate that NS101 is safe and well-tolerated at all doses and binds to the target protein in a dose-proportional manner, as shown by pharmacokinetic biomarkers. This provides a basis to advance to subsequent clinical development stages for neurological disorder treatments.”
Based on the results of this Phase 1 trial, Neural Science plans to increase the potential for developing various neurological disorder treatments and to jointly conduct follow-up clinical trials of NS101 with its domestic partner, Ilyeon Pharmaceutical.
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