A novel formulation for investigational botulinum toxin A

Dr. Cohen

Swiss healthcare company Galderma has announced the phase 2 clinical trial results for its liquid formulation of investigational botulinum toxin, QM1114. The study - conducted as multi-center, randomized, double-blind and placebo-controlled - successfully showcased the safety and efficacy of botulinum toxin type A, according to the company.

“Toxin treatment-naive subjects aged ≥18 years with moderate-to-very severe GLs [glabellar lines] at maximum frown and at least mild GLs at rest were eligible for this multi-centre, double-blind 6-month Phase II study,” according to the abstract from the oral presentation on the subject at the 24th World Congress of Dermatology, Milan.¹ 

As a treatment for glabellar lines, this strain of Clostridium botulinum bacteria is manufactured using an animal-origin free process and was specifically designed for use in aesthetics. 

QM1114 liquid formation reduces the time needed for preparation when compared to the current treatments that require reconstitution before administration. 

“It is an innovation in aesthetics because this is the first botulinum toxin type A that comes in a liquid formulation,” says Joel Cohen, M.D., director of AboutSkin Dermatology and DermSurgery in Colorado, and investigator in the phase 2 clinical trial. 

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More than 70% of users of the currently used treatment do not delegate the reconstitution process, “because they ‘do not feel comfortable with someone else doing it,’” according to Galderma, who cites data on file. 

The use of an already liquid formation would relieve that concern and bring the expectation of eventual market availability. 

“Three different doses were used in the course of the study,” says Dr. Cohen. “Galderma utilized [that information] to come up with the dosing to proceed with in phase 3. Then, they’ll use the data from the study to come up with the next stage, which will be the product that they hope to come to market with.”

Phase 2 concluded with overall positive results, according to the company. 

“At all doses, aesthetic GL treatment with QM1114 was highly effective with long duration, high subject satisfaction and an acceptable safety profile,” according to the 24th World Congress of Dermatology presentation abstract. “In addition, the novel ready-to-use liquid formulation offered a convenient alternative to traditional botulinum toxin type A products requiring reconstitution before injection.”

Along with the trial results, the company also recently received a manufacturing license from the Swedish Medical Products Agency (MPA) for a new manufacturing facility at the Center of Excellence, in Uppsala, Sweden. This facility - said to be state-of-the-art - is designed to meet production and safety requirements specific to QM1114. 

Phase 3 trails for Galderma’s liquid formulation of botulinum toxin type A is expected to enroll approximately 1,500 subjects and begin soon, according to the company.

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References:

1. Evaluation of QM1114, A Novel Ready-to-Use Botulinum Toxin, in Aesthetic Treatment of Glabellar Lines. [abstract] 24th World Congress of Dermatology. June 10-15, 2019. Accessed online Oct. 21, 2019. Available at: https://www.wcd2019milan-dl.org/abstract-book/documents/late-breaking-abstracts/03-aesthetic-cosmetic-dermatology/evaluation-of-qm1114-a-novel-490.pdf