• Results from the pivotal phase III ARCADIA 1 and 2 and OLYMPIA 1 studies evaluating the safety and efficacy of nemolizumab in moderate to severe atopic dermatitis and prurigo nodularis will be presented for the first time as late-breaking abstracts.^1,2
• New data on trifarotene from the phase IV START study showing positive outcomes, patient satisfaction and patient compliance for risk of atrophic acne scarring will be presented. Data from the phase IV LEAP study in post-inflammatory hyperpigmentation (PIH) will also be shared.^3,4
• In total, Galderma will sponsor two symposia and present 15 abstracts with data on sensitive skin, healthy skin ageing and diversity and inclusion in dermatology.

Galderma, the emerging pure-play dermatology category leader, announced today it will be showcasing updates from across its broad and innovative dermatology portfolio at the 32^nd European Academy of Dermatology and Venereology (EADV) congress in Berlin, October 11-14, 2023. For more than 40 years, Galderma has focused exclusively on delivering advances in dermatology, and its extensive presence at this year’s congress underlines the true impact of its industry-leading expertise and ongoing commitment to cutting-edge science, brands and services.

Highly-anticipated presentations include data from the pivotal phase III ARCADIA 1 and ARCADIA 2 clinical studies, which will be presented for the first time. These data, showing the safety and efficacy of nemolizumab in treating skin lesions, itch and sleep disturbance at 16 weeks in adult and adolescent patients with moderate to severe atopic dermatitis, will be shared as a late-breaking abstract on Wednesday, October 11, 2:45-3:00 PM CEST (Hall B).¹

New data from the pivotal phase III OLYMPIA 1 study will also be presented for the first time as a late-breaking abstract on Wednesday, October 11, 3:00-3:15 PM CEST (Hall B), providing confirmation of results from the phase III OLYMPIA 2 study that reinforce nemolizumab’s rapid response in patients with prurigo nodularis.²

Data examining the burden of atopic dermatitis and prurigo nodularis on patients, including additional analyses from OLYMPIA 2 demonstrating improvements in patient-reported pain, disease status and satisfaction will be presented, including during a dedicated symposium on Thursday, October 12, 1:00-2:00 PM CEST (Room 6).^5,6,7

Galderma will also present compelling new data on trifarotene as a treatment for acne and its sequelae. Results from the phase IV START study reinforce Galderma’s confidence in the efficacy and safety of trifarotene vs. vehicle treatment at reducing atrophic acne scarring. The study met its primary endpoint, with a significantly greater reduction in the mean absolute change from baseline in the total atrophic scar count in the trifarotene- vs. vehicle-treated area (−5.9 vs. −2.7; p<0.0001) at week 24. A significant reduction was observed as early as week 2 (−1.5 vs. −0.7; p=0.0072). Results also showed a statistically significant reduction in both total (70% vs. 45%) and inflammatory (76% vs. 48%) lesion count at week 24.³

Additional data include results from the phase IV LEAP study evaluating the safety and efficacy of trifarotene for reducing risk of acne-induced post-inflammatory hyperpigmentation (PIH), which show a rapid and significant improvement in PIH with trifarotene vs. vehicle treatment at week 12. At week 24, both trifarotene and vehicle treatment groups showed improvements from baseline, and the absolute change was comparable.⁴ Visually apparent improvements in hyperpigmentation and reduction in total acne lesion count through to week 24 across all skin types were observed. A separate analysis shows improvements in patient-reported satisfaction and compliance with trifarotene in combination with a tailored skincare routine vs. vehicle treatment with a tailored skincare routine using Cetaphil^® for patients with moderate acne and PIH.⁸ A Galderma-sponsored symposium will further explore recent developments in the topical management of acne and acne sequelae on Wednesday, October 11, 1:00-2:00 PM CEST (Room 6).

Updates from Galderma’s expanding research program of studies examining skin sensitivity will also be shared. Presentations include findings from the largest worldwide survey profiling individuals impacted by sensitive skin syndrome, delivered in collaboration with The George Washington University.⁹ A new approach of management of skin ageing in sensitive skin will also be shared, including in vitro and clinical investigations of a novel face serum designed to target changes in sensitive skin known to trigger skin ageing.^10,11 Results of a meta-analysis of clinical studies, which demonstrated the added value of tailor-made dermocosmetics in the management of itch in sensitive skin sufferers, will also be shared.¹²

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

About Galderma

Galderma is the emerging 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 though 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:

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¹ Silverberg J, et al. Late-breaking abstract presented at EADV 2023

² Stander S, et al. Late-breaking abstract presented at EADV 2023

³ Schleicher S. et al. Phase IV START study results. E-poster presented at EADV 2023

⁴ Andrew A, et al. Phase IV LEAP study results. E-poster presented at EADV 2023

⁵ Reich A, et al. E-poster presented at EADV 2023

⁶ Choi U, et al. E-poster presented at EADV 2023

⁷ Joel MZ, et al. E-poster presented at EADV 2023

⁸ Piccardi N, et al. E-poster presented at EADV 2023

⁹ Berlin I, et al. E-poster presented at EADV 2023

¹⁰ Joly-Tonetti N, et al. E-poster presented at EADV 2023

¹¹ Pellacani G, et al. E-poster presented at EADV 2023

¹² Grivet M, et al. E-Poster presented at EADV 2023

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