Galderma: Positive Phase 2 Results for Investigational Botulinum Toxin

Galderma, a global leader in skin health focused on developing innovative aesthetic solutions, recently announced the Phase 2 clinical trial results for its novel ready-to-use investigational botulinum toxin, QM1114. The multicenter, randomized, double-blind, placebo-controlled study successfully demonstrated the safety and efficacy of Galderma’s liquid formulation of botulinum toxin type A for the treatment of glabellar lines (frown lines). The Phase 3 clinical trial program will begin soon to support regulatory submissions globally.¹

“As a physician, I need to be confident that innovation in aesthetic treatment is the result of scientific rigor. I am encouraged by the results of the Phase 2 QM1114 study, which demonstrated initial safety and efficacy at all doses with high patient satisfaction,” said Dr. Joel Cohen*, Director of AboutSkin Dermatology and DermSurgery in Colorado, and investigator in the Phase 2 clinical trial. “It is exciting to see the development of a new toxin formulation that can offer convenience and the potential to eliminate the need for reconstitution in my practice.”
Derived from Galderma’s proprietary strain of Clostridium botulinum bacteria and manufactured using an animal-origin free process, QM1114 has been designed and developed specifically for use in aesthetics. The QM1114 liquid formulation reduces preparation time needed in clinic and has the potential to increase accuracy, as it is ready-to-use, in contrast with current treatments that require reconstitution before administration. Market research suggests that on average, over 70 percent of injectors do not delegate the reconstitution process because they ‘do not feel comfortable with someone else doing it.’²
Additionally, Galderma recently received a manufacturing license from the Swedish Medical Products Agency (MPA) for a new state-of-the-art manufacturing facility at the Center of Excellence, located in Uppsala, Sweden.³ This new facility, built to the highest quality standards, is designed exclusively to meet the production and safety requirements of QM1114. It will also ensure that Galderma can meet increasing worldwide demand as the company’s innovative aesthetics pipeline grows.
https://www.biospace.com/article/releases/galderma-announces-positive-phase-2-results-for-its-proprietary-liquid-formulation-of-an-investigational-botulinum-toxin-and-approval-of-new-state-of-the-art-manufacturing-facility/