Huons Global said Tuesday that it has finished registering patient applicants for its domestic phase 3 clinical trials for Hutox, a botulinum toxin (BTX) strain used for forehead wrinkle treatment.
Developed by Huons Global’s in-house research institute, Hutox is an outcome of excellent fermentation productivity, high purification technology and the use of ATCC3502 strain, which makes the product distinctive from other rivals, the company said.
The company received approval for its investigational new drug application (IND) for domestic phase 3 clinical trials from the Ministry of Food and Drug Safety (MFDS) in October last year. Subsequently, the company started recruiting patients from three major hospitals, including Chung-Ang University Hospital and Konkuk University Medical Center, in December.
With the recruitment process coming to a close two months earlier than scheduled, it the clinical trials are also likely to end earlier than expected.
The goal of the clinical trial is to demonstrate the efficacy and safety of the treatment of moderate to severe wrinkles in Hutox and confirm the results of the wrinkle reduction effects identified in phase 1 and 2 clinical trials.
The company also aims to expand global sales. The company has shipped Hutox to several countries after receiving export approval at the end of last year.
Huons Global is building a second factory that complies with EU and U.S. current good manufacturing practice (cGMP) regulations to expand its global market reach. The construction of the second plant, located in North Chungcheong Province, will be completed in the first half of 2018. The new plant will expand production capacity by five times, and produce more than five million vials annually, according to the company.
“With the early completion of patient recruitment, the company expects the clinical trials will also finish early,” CEO Kim Wan-seop said. “This, in turn, will allow us to make an earlier entry into the domestic market next year, while vitalizing exports to overseas markets.”
The company expects that Hutox will become one of the primary products at our second plant, Kim added.