Hugel Completes Phase 1 Clinical Trial of Botulinum Toxin Product 'HG102' Containing Lidocaine

[Asia Economy Reporter Lee Gwan-joo] Hugel's next-generation botulinum toxin product under development, 'HG102,' has confirmed efficacy and safety in Phase 1 clinical trials.

Hugel announced on the 6th that it recently received the Clinical Study Report (CSR) for the Phase 1 clinical trial of HG102, a lidocaine-containing liquid botulinum toxin product.

HG102 is a next-generation botulinum toxin formulation developed with a focus on convenience for both practitioners and patients. It is made by adding the local anesthetic lidocaine hydrochloride to the existing freeze-dried powder form of botulinum toxin, converting it into a liquid form. By adding a local anesthetic, it is expected to improve patient comfort related to injection site pain, which has been the biggest inconvenience during botulinum toxin use.

In January last year, Hugel received approval from the Ministry of Food and Drug Safety for the Phase 1 clinical trial plan for HG102. The clinical trial was conducted at Konkuk University Medical Center with a total of 38 patients requiring improvement of moderate or greater glabellar lines. Patients were randomly assigned to either Allergan's 'Botox' treatment group or the HG102 treatment group, and after a single administration of the same dose, the improvement of glabellar lines and safety were compared and evaluated.

As a result, when the investigator evaluated the glabellar lines at maximum frown, there was no statistically significant difference in the proportion of subjects showing an improvement of two grades or more between the control group and the test group. In terms of safety, no newly identified adverse reactions or notable findings were observed.

A Hugel representative explained, “Based on the clinical trial results, administration of HG102 in patients with moderate or greater glabellar lines is expected to have a glabellar line improvement effect similar to that of the control group in terms of efficacy. Regarding safety, no newly identified adverse reactions or notable findings were observed, so it is judged to be safely administrable.” Hugel plans to enter Phase 3 clinical trials this year and obtain product approval in 2025.

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