Huons Global said Thursday that it has launched phase 3 local clinical trials for Hutox, a botulinum toxin (BTX) strain used for forehead wrinkle treatment.
Developed by Huons’ research institute, Hutox is an outcome of an excellent fermentation productivity, high purification technology and the use of ATCC3502 strain, which makes the product distinctive from other rivals, the company said.
The phase 3 clinical trial comes after Huons successfully finished phase 1 and 2 clinical trials in June to test treatments on adults with moderate or severe wrinkles. The previous tests proved the safety and efficacy of the treatment against forehead wrinkles.
The latest clinical trials are now carried out at three medical institutions including Chung-Ang University Hospital and Konkuk University Medical Center. The company refused to disclose the name of the third hospital, citing a confidentiality agreement.
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, compared with the current production volume, and produce more than five million vials annually, according to the company.
“Since Hutox already proved its efficacy and safety in the global market, domestic phase 3 clinical trials are also expected to be completed successfully,” said Kim Wan-seop, CEO of Huons Global. “If the second factory is completed as planned and the entry into the domestic market progresses sequentially, the company expects to gain momentum in sales.”
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