(Health Korea News / Soon-Ho Lee) Huons Group has completed clinical trials for benign masseter hypertrophy (square jaw) for its strategic botulinum toxin product ‘Riztox’. Currently, Daewoong Pharmaceutical’s ‘Nabota’ is the only product with the same indication, so competition for market share between the two products is expected to intensify.
According to the Ministry of Food and Drug Safety on the 26th, Huons Biopharma, a botulinum toxin business subsidiary of Huons Group, completed the final subject observation of the square jaw phase 3 clinical trial of ‘Liztox (export name: Hutox)’ on the 12th and recently conducted clinical trials. The status was changed to terminated.
This clinical trial was conducted to evaluate the safety and effectiveness of ‘Liztox’ in adults aged 19 years or older who need improvement in benign masseter hypertrophy. The clinical trial plan was approved in 2013, and the first subjects were enrolled in July of the same year. The final subjects were selected in December of last year, and drug administration and evaluation were conducted for about a year.
Considering the time it takes for data analysis and approval procedures, it is expected that ‘Liztox’ will be able to secure an indication for improvement of benign masseter hypertrophy as early as next year.
The primary endpoint of the phase 3 clinical trial is the average change in the thickness of both masseter muscles at maximum occlusion measured through ultrasound 12 weeks after administration of ‘Riztox’. ‘Liztox’ has been confirmed to be effective in improving benign masseter hypertrophy in a previously conducted phase 2 clinical trial. No unusual issues were observed in safety comparison with existing botulinum toxin type A preparations.
In the area of improving benign masseter hypertrophy, botulinum toxin is administered directly to the masseter muscle in a minimally invasive manner and can be used as an alternative to conservative or surgical treatment with a relatively simple procedure. Huons expects the competitiveness of ‘Liztox’ to increase further after obtaining the relevant indication. Biopharma is looking ahead.
Huons Biopharma is currently working on expanding the indications for ‘Riztox’, entering the global market, and developing new botulinum toxin preparations in line with the demands of the botulinum toxin preparation market.
Last year, the company completed the phase 3 clinical trial of ‘Liztox’ for the treatment of upper extremity muscle stiffness after stroke and submitted an application for approval to the Ministry of Food and Drug Safety. Attempts to enter the global market are also being actively made, and the approval process is underway in China, which is considered one of the world’s three largest botulinum toxin product markets along with the United States and Europe. In the US and Europe, we have completed our search for partners and are preparing to enter the local market.
Huons Biopharma has reached the final stage of development of ‘HU-045’, a next-generation botulinum toxin preparation that reduces the development of resistance.
Huons Biopharma ended recruiting subjects for the domestic phase 3 clinical trial of ‘HU-045’ last month. The final test subject selection was made about four months after the first test subject recruitment last June, and the test is scheduled to be completed after an evaluation period of about half a year.
‘HU-045’ is a new botulinum toxin preparation that Huons Biopharma is developing to reduce the possibility of developing resistance. By removing non-toxin proteins and purifying neurotoxins with a size of 150 kDa, the possibility of forming neutralizing antibodies was lowered.
In this clinical trial, Huons Biopharma aims to prove efficacy and safety by comparatively evaluating ‘HU-045’ and ‘Xeomin’ from Merz, Germany.
An industry official said, “Huons Biopharma is also constructing a 3rd bio plant as its botulinum toxin preparation business is on track,” adding, “After the completion of the 3rd bio plant, we plan to increase production capacity and begin the overseas expansion of ‘LizTox’ in earnest.”
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