Galderma announces positive results in two Phase III trials for liquid botulinum toxin A
Galderma has announced the results of two Phase III trials for its liquid formulation botulinum toxin A, priming the company to apply for approval in the US and other global markets.
Galderma’s RelabotulinumtoxinA is a novel formulation designed to be ‘ready-to-use’ and eliminate the traditional need to reconstitute the toxin from a powder.
This says the Swiss firm, will remove variability, errors and risks associated with reconstitution which should have a knock-on effect to improve the consistency of results.
The READY (RElabotulinumtoxin Aesthetic Development StudY) Phase III clinical program is composed of four Phase III clinical trials which enrolled more than 1,900 participants.
READY-1 assessed the liquid formulation on moderate to severe frown (glabellar) lines and randomised 300 participants to receive RelabotulinumtoxinA or placebo.
Results from the study showed that the formulation significantly reduced frown line severity and was well tolerated.
After one month, 82.9% of recipients of Galderma’s botulinum toxin had experienced improvement on an assessment of frown line severity, meeting the study’s primary endpoint. No such improvement was observed in the placebo cohort.
In the trial, RelabotulinumtoxinA had a rapid onset of effect - almost 40% of participants reported an effect on day one of receiving treatment.
The effects of the toxin were long-lasting, persisting for up to six months. The median time to return to baseline severity was more than 24 weeks, the duration of the trial.
97% of treated participants also reported being highly satisfied with how natural they looked after one month 88% after six months.
The second study, READY-2, randomised 303 participants with crow’s feet (canthal lines) to receive RelabotulinumtoxinA or placebo.
In this trial, 51.8% of participants in the treatment cohort met the response criteria versus 1.4% of those who received the placebo. Similarly to the READY-1 trial, participants reported responses within one or two days of receiving the formulation and it took 24 weeks on average to return to baseline severity.
Both studies met their primary endpoint, demonstrating a significant ≥2-grade composite improvement (as assessed by both subject and investigator) in glabellar line severity and lateral canthal line severity vs. placebo at month one, with rapid onset of action and up to a six-month duration of action. Additionally, both studies validated the treatment's safety and tolerability profile and there were no serious adverse events.
"We developed this innovative neuromodulator to respond directly to the needs of healthcare professionals and the expectations of patients who are looking for a safe, effective, long-lasting treatment that offers consistency in results for frown lines and crow’s feet, which can have a significant impact on patients’ self-esteem and well-being,” said Galderma’s global head of research & development, Baldo Scassellati in a press release.
“We are looking forward to submitting the data to the US and global authorities as part of the next step in bringing this potential, new treatment to patients.”
The firm already received a positive decision for use in Europe last year.
References:
- Shridharani, S., et al. Treatment of moderate-to-severe glabellar lines with RelabotulinumtoxinA, a new liquid botulinum toxin: Clinical efficacy and safety results from the READY-1 Phase III trial. Poster presented at Vegas Cosmetic Surgery & Aesthetic Dermatology 2022, Las Vegas, NV, June 8-11, 2022
- Ibrahim, SF, et al. Treatment of lateral canthal lines with RelabotulinumtoxinA, a new liquid botulinum toxin: Clinical efficacy and safety results from the READY-2 Phase III trial. Poster presented at Vegas Cosmetic Surgery & Aesthetic Dermatology 2022, Las Vegas, NV, June 8-11, 2022.
- Liljegren Sundberg, Å and Ståhl, U. Relabotulinum toxin – a novel, high purity BoNT-A1 in liquid formulation. Poster presented at TOXINS, virtual online event, January 16-17, 2021.
Galderma has announced the results of two Phase III trials for its liquid formulation botulinum toxin A, priming the company to apply for approval in the US and other global markets.
Galderma’s RelabotulinumtoxinA is a novel formulation designed to be ‘ready-to-use’ and eliminate the traditional need to reconstitute the toxin from a powder.
This says the Swiss firm, will remove variability, errors and risks associated with reconstitution which should have a knock-on effect to improve the consistency of results.
The READY (RElabotulinumtoxin Aesthetic Development StudY) Phase III clinical program is composed of four Phase III clinical trials which enrolled more than 1,900 participants.
READY-1 assessed the liquid formulation on moderate to severe frown (glabellar) lines and randomised 300 participants to receive RelabotulinumtoxinA or placebo.
Results from the study showed that the formulation significantly reduced frown line severity and was well tolerated.
After one month, 82.9% of recipients of Galderma’s botulinum toxin had experienced improvement on an assessment of frown line severity, meeting the study’s primary endpoint. No such improvement was observed in the placebo cohort.
In the trial, RelabotulinumtoxinA had a rapid onset of effect - almost 40% of participants reported an effect on day one of receiving treatment.
The effects of the toxin were long-lasting, persisting for up to six months. The median time to return to baseline severity was more than 24 weeks, the duration of the trial.
97% of treated participants also reported being highly satisfied with how natural they looked after one month 88% after six months.
The second study, READY-2, randomised 303 participants with crow’s feet (canthal lines) to receive RelabotulinumtoxinA or placebo.
In this trial, 51.8% of participants in the treatment cohort met the response criteria versus 1.4% of those who received the placebo. Similarly to the READY-1 trial, participants reported responses within one or two days of receiving the formulation and it took 24 weeks on average to return to baseline severity.
Both studies met their primary endpoint, demonstrating a significant ≥2-grade composite improvement (as assessed by both subject and investigator) in glabellar line severity and lateral canthal line severity vs. placebo at month one, with rapid onset of action and up to a six-month duration of action. Additionally, both studies validated the treatment's safety and tolerability profile and there were no serious adverse events.
"We developed this innovative neuromodulator to respond directly to the needs of healthcare professionals and the expectations of patients who are looking for a safe, effective, long-lasting treatment that offers consistency in results for frown lines and crow’s feet, which can have a significant impact on patients’ self-esteem and well-being,” said Galderma’s global head of research & development, Baldo Scassellati in a press release.
“We are looking forward to submitting the data to the US and global authorities as part of the next step in bringing this potential, new treatment to patients.”
The firm already received a positive decision for use in Europe last year.
References:
- Shridharani, S., et al. Treatment of moderate-to-severe glabellar lines with RelabotulinumtoxinA, a new liquid botulinum toxin: Clinical efficacy and safety results from the READY-1 Phase III trial. Poster presented at Vegas Cosmetic Surgery & Aesthetic Dermatology 2022, Las Vegas, NV, June 8-11, 2022
- Ibrahim, SF, et al. Treatment of lateral canthal lines with RelabotulinumtoxinA, a new liquid botulinum toxin: Clinical efficacy and safety results from the READY-2 Phase III trial. Poster presented at Vegas Cosmetic Surgery & Aesthetic Dermatology 2022, Las Vegas, NV, June 8-11, 2022.
- Liljegren Sundberg, Å and Ståhl, U. Relabotulinum toxin – a novel, high purity BoNT-A1 in liquid formulation. Poster presented at TOXINS, virtual online event, January 16-17, 2021.