Protox, a DSK subsidiary, is expected to apply for a phase 1 clinical trial this month to develop botulinum toxin (Botox).It also applies for GMP (Korea Good Manufacturing Practice) certification for export.

A DSK official said on the 8th, “The researchers have secured the results necessary to conduct the phase 1 clinical trial, and clinical applications will be made in April,” adding, “Discussions with clinical hospitals are ongoing and the goal is to take clinical doses within this year.”

Protox’s botulinum toxin A drug (tentative name Protoxin) pre-clinization has been conducted since February last year at Biotoxtech, a certified GLP institution, and the Safety Evaluation Institute.According to the company, no abnormal symptoms were observed during the animal test observation period.In particular, in terms of the efficacy of “inhibiting muscle contraction,” it was confirmed that it was more persistent than control materials at equivalent or some doses.

Protox applied for a phase 1 clinical trial plan (IND) to the Korea Food and Drug Administration (KFDA) in April this year based on the results of its predecessor, and the medication clinical trial is scheduled to begin in earnest this year.

The bio-production plant that will produce protoxin began construction in May 2017 in the Hyangnam Pharmaceutical Complex in Hwaseong, Gyeonggi-do, and was completed in about two years.The total project cost was about 32 billion won, and the factory was designed based on Good Manufacturing Practice (GMP) with a total floor area of 6,227㎡ (about 1,886 pyeong).

With the completion of the plant, Protox will be able to produce 2.7 million vials of Botox per year.In order to increase production to 5.4 million vials per year in the future, redesigns are underway, including installing additional freeze dryers.

Reporter Ko Jong-min, kjm@etoday.co.kr