CKD Bio said it has confirmed the non-inferiority of CKDB-501A, aimed at improving moderate to severe frown lines, compared to Botox through a phase 3 clinical trial's topline results.

The analysis of the data revealed that the improvement rate for frown lines when frowning was 80.69 percent (117 out of 145 participants) for CKDB-501A, compared to 70.83 percent (102 out of 144 participants) for the control group using Allergan's Botox.

Based on these results, CKD Bio explained that CKDB-501A was not inferior to Botox in terms of efficacy.

Additionally, the incidence rate of all adverse events was 14.09 percent for CKDB-501A and 12 percent for Botox, indicating no significant difference between the two groups. The company also noted that no serious adverse events or events leading to trial discontinuation occurred.

The trial, conducted from April to November 2023, involved 300 adult participants aged between 19 and 65 years, assessing the safety and efficacy of CKDB-501A in comparison to Botox for the improvement of moderate to severe frown lines.

The company believes that CKDB-501A, developed without the use of animal-derived components (albumin-free and Non-animal excipient), will make a significant impact in the BTX market, with the potential for replacing imports and contributing to the national economy through exports.

With these positive outcomes, CKD Bio plans to compile a clinical trial report and apply for domestic product approval with the Ministry of Food and Drug Safety.