Positive Phase 2 Results Seen With Galderma’s Proprietary Liquid Toxin for Frown Lines
The Phase 3 clinical trial program will begin soon to support regulatory submissions globally.
Galderma’s novel liquid abotulinum toxin, QM1114, is safe and effective for the treatment of glabellar lines, according to Phase 2 study results.
Pivotal Phase 3 trials for Galderma's liquid formulation of botulinum toxin type A for the treatment of glabellar lines are expected to begin soon and enroll approximately 1,500 subjects.
Derived from Galderma's proprietary strain of Clostridium botulinum bacteria and manufactured using an animal-origin free process, 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, more than 70 percent of injectors do not delegate the reconstitution process because they 'do not feel comfortable with someone else doing it.
"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," says Joel Cohen, MD, Director of AboutSkin Dermatology and DermSurgery in Colorado, and investigator in the Phase 2 clinical trial, in a news release. "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."
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. This new facility is designed exclusively to meet the production and safety requirements of QM1114.
"Innovation is at the core of our business and our investment is backed by a trusted legacy of creating unique solutions that meet our customer needs," says Alexandre Brennan, Global Head of Aesthetics, Galderma. "We are proud to be leaders in toxin research, and with these studies for a novel liquid formulation of botulinum toxin type A, we are building on our aesthetics heritage by advancing new treatments at our Center of Excellence in Sweden."