Liztox, a botulinum toxin product of Huons BiopharmaHuons Biopharma has received approval from the Ministry of Food and Safety for the phase 3 IND clinical trial of its Liztox (Hutox in the export name), a botulinum toxin (BTX) product treating benign masseteric hypertrophy (square jaw).

The company said Wednesday that it plans to conduct the test to evaluate efficacy and safety at four domestic hospitals, including Chung Ang University Hospital, in 176 adults aged 19 and older who need improvement in benign masseteric hypertrophy.

Huons Biopharma explained that it confirmed the improvement effect of Liztox in treating square jaw through a phase 2 clinical trial completed in the first half of 2022.

The company added that the drug could be used as an alternative option for preservative and surgical treatment through the relatively simple procedure of administering BTX directly to the masseter in a minimally invasive method to improve benign masseteric hypertrophy.

Liztox currently has indications for improving wrinkles between the eyebrows and around the eyes in the cosmetic area. Through the phase 3 trial, the company plans to further increase its competitiveness by acquiring additional indications.

Besides, Huons Biopharma is also speeding up the development of new botulinum toxin products. In the first half of this year, it will complete the phase 2 clinical trial to improve wrinkles between the eyebrows of botulinum toxin (150kDa), which reduces resistance expression. It also plans to begin its phase 3 clinical trial this year and obtain approval for new botulinum toxin products.

"We are trying to expand the indications and production of Liztox in line with the demands of the botulinum toxin market,” a company official said. “We will also actively respond to increasing demand for botulinum toxin through phase 3 clinical trial of upper extremity muscle stiffness treatment after stroke and the expansion of new factories.