Protox’s botulinum toxin A formulation ‘Protoxin’ will soon enter phase 3 clinical trials.

The Ministry of Food and Drug Safety submitted a report submitted by Protox on the 1st, titled ‘Multicenter, double-blind, random allocation to comparatively evaluate the effectiveness and safety of Protoxin and Botox in adults requiring improvement of moderate or severe glabellar lines.’ A ‘parallel, active-controlled, phase 3 clinical trial’ was approved.

Phase 3 clinical trials will be conducted at Chung-Ang University Hospital.

To develop botulinum toxin, Protox invested a total project cost of approximately KRW 32 billion in the Hyangnam Pharmaceutical Complex in Hwaseong City in April 2019 and established a GMP (good manufacturing practice) facility with a total floor area of ​​6,227 m2 (approximately 1,886 pyeong) and 4 floors above ground. On October 7 of that year, a pharmaceutical manufacturing license was obtained.

Protoxin obtained clinical plan approval and GMP approval on July 31, 2020, and has been conducting phase 2 clinical trials since last year.

Protoxin, developed from the ATCC3502 strain, is undergoing clinical trials as a finished product that has verified quality control results that meet the standards and test methods, including non-clinical safety and efficacy data in line with international standards and potency of the raw solution and finished product.

The company aims to launch the product in 2023 after successfully completing phase 3 clinical trials.
Reporter Hye-kyung Lee (hgrace7@dailypharm.com)