TWi Biotechnology (Stock Code: 6610) Announces Key Efficacy Results from the Phase II Clinical Trial of NORA520 for the Treatment of Postpartum Depression (PPD)

This randomized, double-blind, placebo-controlled study enrolled a total of 93 adult women with severe postpartum depression. Participants were randomized in a 1:1:1 ratio to receive placebo or one of two dosing-frequency regimens of NORA520. Subjects were hospitalized and received oral administration for three consecutive days starting on Day 1. The study employed a closed testing procedure to control for potential statistical bias arising from multiplicity testing. The primary endpoint assessed the change from baseline in the Hamilton Depression Rating Scale (HAM-D17) score on Day 4, with additional secondary endpoints evaluating efficacy on Day 8 and Day 30.

According to the primary efficacy analysis, the pooled results of the two NORA520 dosing groups did not demonstrate a statistically significant difference compared with placebo, with a p-value of 0.72. However, the overall safety profile of NORA520 remained favorable. No serious adverse events were reported during the trial. While a small number of subjects experienced somnolence, the incidence was comparable between the treatment and placebo groups. Overall tolerability was good, indicating that short-term administration of NORA520 is safe.

TWiB noted that preliminary data show nearly half of the patients in both NORA520 treatment groups achieved a therapeutic response; however, the placebo group exhibited a similarly high response rate. The clinical and scientific teams are conducting a comprehensive assessment to evaluate potential reasons why the results differed from expectations, including further examination of all efficacy endpoints, subgroup analyses, and plasma drug concentration data. Following completion of these in-depth analyses, the Company will reassess and refine the future clinical development strategy for NORA520. TWiB emphasized that although the primary endpoint did not achieve statistical significance in this trial, unmet medical need remains substantial in the field of mental health. The Company remains committed to progressing its development programs with scientific rigor and caution to ensure that the future direction of NORA520 aligns with market needs and regulatory guidance.

In addition to NORA520, TWiB’s pipeline includes AC-203, which is currently being evaluated in a global Phase II/III clinical trial. Enrollment is actively ongoing across 35 clinical sites in 18 countries worldwide, with an interim analysis planned for the first quarter of next year (2026).