ASDS 2024: New Phase III READY-4 Data Demonstrate Long-Term Safety and Efficacy of Galderma?s RelabotulinumtoxinA

21.10.2024 - 08:01:09

Business Wire India

First results from the phase III READY-4 trial demonstrate the long-term safety of repeated injections of RelabotulinumtoxinA for both frown lines and crow’s feet, with efficacy and patient satisfaction maintained across multiple treatments¹
These results were presented alongside additional data from the phase III READY clinical trial program showing RelabotulinumtoxinA’s long duration of effect for six months for frown lines and crow’s feet^2,3
Data presented add to the body of evidence demonstrating the safety and efficacy of RelabotulinumtoxinA, including its onset of action as early as day one^4,5
Developed and manufactured by Galderma, RelabotulinumtoxinA is the first and only ready-to-use liquid neuromodulator developed using PEARL™ Technology that is optimized for simple volumetric dosing to increase ease-of-use^6-8
Further update on neuromodulators: the International Chamber of Commerce (ICC) reaffirmed the scope of Galderma’s exclusive distribution rights with respect to Azzalure® and Dysport® and Galderma’s rights to commercialize these products in additional countries in Eastern Europe and Central Asia, following the completion of arbitration proceedings in October 2024

The READY-4 study met its primary and secondary endpoints, with less than one in five participants experiencing treatment-related treatment-emergent adverse events (TEAEs), and all events deemed mild or moderate.¹ Efficacy and patient satisfaction were also maintained across multiple treatments.¹ The data were presented at the American Society for Dermatologic Surgery (ASDS) 2024 Annual Meeting, held in Florida from October 17-20.

Developed and manufactured by Galderma, RelabotulinumtoxinA is the first and only ready-to-use liquid neuromodulator created with PEARL^™ Technology that is designed to preserve molecule integrity to deliver a highly active, innovative, complex-free molecule.^6-8 Previously announced data from the READY clinical trial program have demonstrated that up to 39% of patients see effects from day one and up to 75% of patients maintain improvements for six months for frown lines and crow’s feet when treated with RelabotulinumtoxinA.^4,5,9

“As RelabotulinumtoxinAis the first neuromodulator to be developed and manufactured by Galderma, we’re proud to be able to share more data from our READY clinical program. These READY-4 data demonstrate RelabotulinumtoxinA’s consistent safety and efficacy profile with repeated injections over a year, supporting its potential to be a safe, effective, and durable treatment for both frown lines and crow's feet.”

BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D.

GLOBAL HEAD OF R&D

GALDERMA

READY-4 is a phase III, multicenter, open-label study, designed to evaluate the safety of RelabotulinumtoxinA for the long-term treatment of moderate-to-severe frown lines and crow’s feet in more than 900 participants. Injections were administered at a minimum of 12 weeks apart, in up to four cycles over 12 months.^1,10

Results demonstrate the long-term safety of repeated RelabotulinumtoxinA injections, consistent with the safety profile observed in the phase III READY-1, -2 and -3 clinical trials.^1,4,9,11TEAEs were all mild to moderate, reported by 18% of participants and with similar occurrence across cycles one to four (11%, 7%, 7%, and 10% in cycle one, two, three, and four, respectively).¹

Efficacy was also maintained, with most participants achieving none-or-mild wrinkle severity at one month, which was maintained across multiple treatments throughout 12 months. Participants also reported high treatment satisfaction at one month (?84%).¹

“These data add to the already extensive evidence base showcasing the potential benefits of RelabotulinumtoxinA. Having demonstrated long-term safety, as well as ease of use, sustained results, and an onset of action as early as day one, RelabotulinumtoxinA has the potential to influence the neuromodulator space by addressing and going beyond current treatment limitations, for both physicians and our patients.”

DR. KENNETH BEER, M.D.

READY-4 CLINICAL TRIAL INVESTIGATOR

Board Certified Dermatologist

Founder of Beer Dermatology & The Cosmetic Bootcamp

Additional data on RelabotulinumtoxinA were presented at ASDS, including:

Data from the phase III READY-3 study, previously presented at the TOXINS 2024 conference, demonstrated that RelabotulinumtoxinA significantly improves both frown lines and crow’s feet, when treated alone or simultaneously, with long duration of effect for six months, a favorable safety profile, and high patient satisfaction^2,11
Pooled data from a post-hoc analysis of the READY-1, -2 and -3 studies showed that there were similarly high rates of improvement for both frown lines and crow’s feet following treatment with RelabotulinumtoxinA in people with different skin types, ethnicity, and race, affirming its efficacy and safety across diverse populations³

More details on Galderma’s scientific presentations at ASDS can be found here.

As previously communicated, Galderma completed its European decentralized procedure for RelabotulinumtoxinA in July 2024, resulting in a positive decision, and national approvals are now under finalization. RelabotulinumtoxinA also received a marketing authorization in Australia earlier this year. Regulatory applications for RelabotulinumtoxinA for the treatment of frown lines and crow’s feet will continue to be submitted and assessed by additional authorities globally. The development of RelabotulinumtoxinA is a key outcome of our exciting and compelling innovation pipeline and Galderma is working to launch it in the markets in which it is approved in the first half of 2025.

Update on International Chamber of Commerce (ICC) arbitration

The arbitration proceeding initiated by Galderma against Ipsen at the ICC related to the territorial scope of the Azzalure^® and Dysport^® (abobotulinumtoxinA) commercial partnership under the 2007 European development and distribution agreement has now been completed. The Tribunal of the ICC issued a final award in October 2024, reaffirming the scope of Galderma’s exclusive distribution rights with respect to Azzalure^® and Dysport^®. The award confirmed Galderma’s rights to commercialize Azzalure^® and Dysport^® in certain additional countries, including in Eastern Europe and Central Asia, that had been in dispute between the parties but dismissed Galderma’s claim for monetary compensation related to the timing of the transfer of such rights. Galderma and Ipsen continue to work in close partnership to grow Azzalure^® and Dysport^® sales in the territories of their commercial alliance.

About RelabotulinumtoxinA

Pioneered by Galderma, RelabotulinumtoxinA is the first and only ready-to-use liquid neuromodulator created with PEARL^™ Technology that is designed to preserve molecule integrity.^6,7 PEARL^™ Technology is designed to deliver a highly active, innovative, complex-free molecule, with up to 39% of patients seeing effects from day one and up to 75% of patients maintaining improvements for six months.^4-7,9RelabotulinumtoxinA is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time.^6,7 It was entirely developed and manufactured by Galderma to expand its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market.

About the READY-4 clinical trial (NCT04225260)^1,10

READY-4 is part of Galderma’s phase III READY (RElabotulinumtoxin Aesthetic Development StudY) clinical trial program, composed of four phase III clinical trials which enrolled more than 1,900 participants, and investigated the safety, efficacy, rapidity of onset, and/or durability of RelabotulinumtoxinA for six months on:^1,4,5,10,12

Frown lines (READY-1)⁴
Crow’s feet (READY-2)⁵
Frown lines and crow’s feet when treated alone or simultaneously (READY-3)¹²

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References:

Beer K, et al. READY-4: Long-term safety with repeated injections using RelabotulinumtoxinA, a novel liquid formulation botulinum toxin, in the treatment of glabellar and lateral canthal lines. E-poster presented at: ASDS 2024; October 17-20, 2024; Orlando, FL
Prather HB, et al. Efficacy and safety of a novel formulation liquid botulinum toxin, RelabotulinumtoxinA, when used for combination treatment of glabellar and lateral canthal lines. E-poster presented at: ASDS 2024; October 17-20, 2024; Orlando, FL
Ibrahim SF, et al. RelaBoNT-A treatment of glabellar lines and lateral canthal lines across different ethnicity and race: Pooled data from three phase III studies. E-poster presented at: ASDS 2024; October 17-20, 2024; Orlando, FL
Shridharani SM, et al. Efficacy and Safety of RelabotulinumtoxinA, a New Ready-to-Use Liquid Formulation Botulinum Toxin: Results From the READY-1 Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial in Glabellar Lines. ASJ. 2024; sjae131
Galderma. Data on file. Clinical Study Report for Protocol 43QM1901: READY-2. Galderma Laboratories; 2021
Sundberg AL and Stahl U. Relabotulinum toxin - a novel, high purity BoNT-A1 in liquid formulation. Presented at: TOXINS 2021; Jan 16-17, 2021; virtual meeting
Do M, et al. Purification process of a complex-free highly purified botulinum neurotoxin type A1 (BoNT-A1) - relabotulinumtoxinA. Presented at: TOXINS 2022; July 27-30, 2022; New Orleans, LA
Persson C, et al. Patient and Investigator Treatment Experience with Ready-to-Use AbobotulinumtoxinA Solution Versus Powder BotulinumtoxinA for Treatment of Glabellar Lines. Abstract presented at TOXINS 2024; Jan 17-20, 2024, Berlin
Ablon G, et al. Treatment of Lateral Canthal Lines with RelabotulinumtoxinA, an Investigational Liquid Botulinum Toxin: Clinical Efficacy and Safety Results from the READY-2 Phase III Trial. Abstract presented at TOXINS 2024; Jan 17-20, 2024, Berlin
Galderma. Data on file. Clinical Study Report for Protocol 43QM1903: READY-4. Galderma Laboratories; 2021
Bertucci V, et al. Efficacy and Safety of a Novel Formulation Liquid Botulinum Toxin, RelabotulinumtoxinA, when used for Combination Treatment of Glabellar and Lateral Canthal Lines. Abstract presented at TOXINS 2024; Jan 17-20, 2024, Berlin
Galderma. Data on file. Clinical Study Report for Protocol 43QM1902: READY-3. Galderma Laboratories; 2021