Daewoong Pharmaceutical Announces Successful 'Extra Strength' Results of US Phase 2 Clinical Trial for High-dose Administration of Botulinum Toxin

16 Nov 2023
  • High-dose Jeuveau, with a dosage double that of the existing 20 units, has succeeded in Phase 2 clinical trials as 'Extra Strength'
  • Demonstrating a proven long-term efficacy of 6 months or 26 weeks, Jeuveau enhances global product competitiveness by providing various option for treatments
  • Glabellar Line Scale (GLS) and Post-Procedure Improvement Assessment Scale (GAIS), high-dose 40-unit weekly treatment demonstrated long-term effects for 26 weeks or 6 months
Daewoong Pharmaceutical Announces Successful 'Extra Strength' Results of US Phase 2 Clinical Trial for High-dose Administration of Botulinum Toxin

Daewoong Pharmaceutical is proud to announce the successful completion of a Phase 2 clinical trial for its botulinum toxin type-A product in the United States. Evolus announced the long-term effects of 40-unit Jeuveau for 6 months (26 weeks) at the American Society for Dermatologic Surgery (ASDS) held in Chicago on the 3rd.

Through this phase 2 clinical trial, Evolus finally confirmed the long-term effects of high-dose 40-unit Jeuveau for 6 months (26 weeks). It is the same as the interim results of the phase 2 clinical trial for the 40-unit Jeuveau, which was successfully completed last June. The active control group of 40-unit Jeuveau was 20-unit Botox and 20-unit Jeuveau, and the side effect results were similar to those of the active control group, and no serious side effects were found.

This clinical trial used the Glabellar Line Scale (GLS), which indexes the degree of wrinkles between the eyebrows, to measure the improvement and lasting effects of high-dose 40-unit supplements on glabellar wrinkles. Based on the glabellar wrinkles scale at the patient's maximum frown, The period it takes for the patient to return to the original glabellar wrinkles scale after the procedure, The duration of effect for patients who showed improvement in glabellar wrinkles and The post-procedure improvement evaluation scale (GAIS. Global Aesthetic Improvement Scale) was measured separately.

Through the final results of phase 2 clinical trials, the high-dose 40-unit Jeuveau was able to provide patients with various options by securing flexibility in the treatment cycle. Through this clinical trial, we were able to provide a variety of options by securing flexibility in the treatment cycle of high-dose injections, further strengthening our global product competitiveness.

Sung-Soo Park, Vice President of Daewoong Pharmaceutical, commented "Through this clinical trial, both companies have proven the long-term effectiveness and safety of Jeuveau and will expand their global market share"

Forward-Looking Statements

This press release contains forward-looking statements that are based on the current beliefs and expectations of Daewoong Pharmaceutical's management. Factors that could cause or contribute to such differences include, but are not limited to: (1) Regulatory and governmental approvals: The approval process for pharmaceutical products is subject to extensive regulations and may involve uncertainties and delays. Any failure to obtain necessary approvals or the occurrence of delays in the approval process could adversely affect Daewoong Pharmaceutical's business and results of operations; and (2) Clinical trials: The success of Daewoong Pharmaceutical's products depends on the results of clinical trials. The results of early clinical trials may not be indicative of the results of later-stage or larger-scale clinical trials.

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