Huons Biopharma "Next-Generation Toxin 'HU-045', Phase 3 Trial Plan Approved"

Huons Biopharma announced on the 16th that it has received approval from the Ministry of Food and Drug Safety for the clinical phase 3 trial plan (IND) of its self-developed next-generation botulinum toxin (BTX) formulation 'HU-045.'

Huons Biopharma CI. [Image provided by Huons Biopharma]

Huons Biopharma plans to conduct safety and efficacy evaluations of HU-045 at a dose of 100 units (150kDa) in adults aged 19 and older with moderate or greater glabellar lines at three domestic institutions.

Following the phase 1 clinical trial of HU-045 in January 2020, Huons Biopharma clinically confirmed the improvement effect on moderate to severe glabellar lines through a phase 2 trial completed in December last year.

HU-045 is a next-generation BTX formulation developed by Huons Biopharma to address resistance issues. To reduce the possibility of resistance development, non-toxic proteins were removed, and neurotoxin proteins of 150kDa size were purified to lower the likelihood of neutralizing antibody formation.

Huons Biopharma plans to focus on obtaining approval for the new HU-045 toxin formulation and simultaneously expanding the indications of its existing BTX formulation 'Riztox' (export name: HUTOX). Riztox aims to enhance competitiveness by acquiring additional indications beyond glabellar and periorbital wrinkle improvement. In March, Huons Biopharma received approval for a phase 3 clinical trial plan for the improvement of benign masseter hypertrophy (square jaw). Recently, it submitted a product approval application to the Ministry of Food and Drug Safety to add an indication for upper limb spasticity after stroke.

The company is also accelerating its global market expansion. To enter the BTX Big 3 markets of the United States, Europe, and China, Huons Biopharma has formed partnerships with leading local aesthetic companies and plans to begin sequential supply starting in 2024. Additionally, it has obtained product approvals and is exporting to 11 countries including Russia, Iraq, and Kazakhstan. Clinical trials and approval procedures are underway in Latin American countries such as Peru.

A Huons Biopharma representative stated, "Following the existing Riztox, we are accelerating the development of next-generation botulinum toxin formulations such as HU-045. We plan to promptly complete the phase 3 clinical trial for glabellar line improvement of HU-045 and obtain approval to actively respond to the increasing demand for botulinum toxin."

This content was produced with the assistance of AI translation services.