Protox, a DSK subsidiary, announced on the 20th that it has received IRB (Clinical Research Review Committee) approval from Pusan National University Hospital for phase 3 clinical trials of botulinum toxin type A “Protoxin”.

Protox was approved by the Ministry of Food and Drug Safety in April this year for a phase 3 clinical trial plan for Protoxin.Protox will compare and evaluate the effectiveness and safety of Protoxin and Botox in “adults who require improvement of moderate or severe wrinkles” in phase 3 clinical trials.

Protox submitted an application for deliberation to a total of five hospitals IRB, Konkuk University Hospital, Kyung Hee University Hospital, Nowon Eulji Hospital, Busan National University Hospital, and Chung-Ang University Hospital for phase 3 clinical trials.Protox received IRB approval for phase 3 clinical trials at Pusan National University Hospital on the 5th, and other hospitals are expected to complete the deliberation within August.

Protoxin is a toxin product developed by Protox based on “ATCC3502”, and Protox commissioned a genetic analysis agency to analyze the gene sequence of the strain, and it was confirmed that it matched 99.99% with ATCC3502 species registered with the National Center for Biological Information (NCBI).

Based on non-clinical safety and efficacy data that meet international standards, Protox plans to conduct phase 3 clinical trials as a finished product that verifies quality control results that meet standards and test methods such as undiluted solution and completion titer.Protox has completed verification and evaluation of the safety and effectiveness of Protoxin through phase 1 and 2 clinical trials in Korea.

A Protox official said, “We plan to conduct phase 3 clinical trials in five domestic hospitals for 280 people,” adding, “As we have been recognized for safety and efficacy through phase 1 and 2, we will focus our capabilities on clinical management with the aim of launching products through successful phase 3 clinical trials.”

Protox is equipped with manufacturing facilities that can be produced and operated with high quality standards, such as installing a filling line from Germany’s “Bausch” company that meets international standards for the first time in Korea, he added.

Meanwhile, Protox invested about 32 billion won in the Hyangnam Pharmaceutical Complex in Hwaseong, Gyeonggi-do in 2017 to complete a four-story Protoxin liquor production facility with a total floor area of 6,227㎡ (about 1,886 pyeong).Protox received a pharmaceutical manufacturing license for the production facility in 2019 and obtained GMP certification in July 2020.

Pharmnews Reporter Lee Kwon-koo kwon9@pharmnews.com