Business Wire

AAD 2023: Late-Breaking Phase III Results Demonstrate nemolizumab’s Significant Impact on Prurigo Nodularis

Share

Galderma, the leading company solely dedicated to advancing the future of dermatology, today premiered the positive phase III results from the OLYMPIA 2 trial evaluating the efficacy, safety, pharmacokinetics and immunogenicity of nemolizumab compared with placebo in adult patients with prurigo nodularis. The results were presented as a late-breaking presentation at the 2023 American Academy of Dermatology (AAD) Annual Meeting by Dr. Shawn Kwatra, Associate Professor of Dermatology at the Johns Hopkins University School of Medicine. Galderma has an extensive presence at the meeting with further updates from its broad portfolio across Therapeutic Dermatology, Dermatological Skincare and Injectable Aesthetics.

The phase III OLYMPIA 2 trial met all primary endpoints, showing nemolizumab monotherapy significantly improved pruritus (itch) and skin lesions compared with placebo in adult patients with moderate to severe prurigo nodularis. Results showed that:

  • 56 percent of nemolizumab-treated patients achieved a response in itch intensity, as defined by an at least 4-point improvement in peak-pruritus numerical rating scale (PP-NRS) score, compared to 21 percent in the placebo group (p<0.0001)
  • 38 percent of nemolizumab-treated patients reached treatment success in skin lesions, as defined by an investigator’s global assessment (IGA) score of 0 or 1, compared to 11 percent in the placebo group (p<0.0001)

Key secondary endpoints showed rapid onset of action and significant improvements in itch and sleep disturbance (p<0.0001) as early as week 4:

  • Over five times as many patients in the nemolizumab group vs placebo achieved significant and clinically meaningful improvement in itch intensity, as defined by a 4-point improvement in PP-NRS - (41.0% for nemolizumab vs 7.7% for placebo p<0.0001)
  • Nearly four times as many patients in the nemolizumab group versus placebo achieved significant and clinically meaningful improvement in sleep disturbance as measured by a 4-point improvement in sleep disturbance numerical rating scale (SD-NRS) - (37.2% for nemolizumab vs 9.9% for placebo p<0.0001)
  • The safety profile was consistent with the phase II trial results

“OLYMPIA 2 is a key piece of the largest phase III clinical development program ever undertaken in prurigo nodularis to date. On behalf of my co-investigators worldwide, I am honored and proud to present the study results to the scientific community in a late-breaking presentation. The results confirm the potential of this every four weeks injectable monoclonal antibody targeting the IL-31 receptor alpha, with rapidly acting effects on itch and sleep disturbance, and subsequent improvement of skin lesions.”

SHAWN KWATRA, M.D.
ASSOCIATE PROFESSOR OF DERMATOLOGY
JOHN HOPKINS UNIVERSITY

Further commitment to diversity in dermatology announced
Also at the congress, Galderma shared an exciting update on the sponsorship of the Atlas initiative, in a highly anticipated booth session focused on Diversity and Inclusion in Dermatology. The unique educational session explored how to diagnose dermatologic conditions in an array of skin tones, leveraging the renowned book and online gallery ‘Full Spectrum of Dermatology: A Diverse and Inclusive Atlas’, from the George Washington University School of Medicine. The event took place on Friday, March 17 and was hosted by editors of the Atlas, Dr. Adam Friedman and Dr. Misty Eleryan. As part of the Galderma sponsorship, copies of the Atlas book are being distributed throughout the AAD congress. Galderma is also proud to be providing an additional financial grant to pilot a pathway for other healthcare professionals to contribute to the online gallery.

“We are so pleased that we’re able to bring so much powerful new data to this year’s AAD congress. The data premiere from OLYMPIA 2 confirms the potential that nemolizumab is expected to improve outcomes for people with prurigo nodularis, which can have such a profound impact on the lives of those affected. Beyond this, our continued involvement and investment in the Atlas program demonstrates our commitment to address every skin need, with diversity and inclusion at the very heart of that promise.”

BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D.
GLOBAL HEAD OF R&D
GALDERMA

Extensive updates from Galderma’s broad and innovative portfolio through posters and presentation sessions
Galderma is the only pure-play dermatology category leader, with more than 40 years of heritage in dermatology. Its continued commitment to delivering science and innovation across a highly differentiated portfolio is reflected in its extensive presence at AAD. More details on Galderma’s scientific poster presentations can be found here.

About the OLYMPIA 2 trial
OLYMPIA 2 was a randomized, double-blind, placebo-controlled phase III clinical trial, to assess the efficacy and safety of nemolizumab monotherapy compared with placebo in patients at least 18 years of age with prurigo nodularis after a 16-week treatment period. The trial also assessed pharmacokinetics and immunogenicity of nemolizumab compared to placebo. OLYMPIA 2 included 274 patients with moderate-to-severe prurigo nodularis.

About prurigo nodularis
Prurigo nodularis is a debilitating, chronic skin condition with thick skin nodules covering large body areas and associated intense itch.1,2,3 Prurigo nodularis affects an estimated 72 per 100,000 adults aged 18-64 years in the United States, primarily middle-aged women and disproportionately people of African descent.1,4

About nemolizumab
Nemolizumab is an investigational drug and Galderma has not received approval for any indication in any country. Nemolizumab is a first-in-class investigational monoclonal antibody directed against the IL-31 receptor alpha that blocks signaling from IL-31. IL-31 is a neuroimmune cytokine that is recognized as driving multiple disease mechanisms in both prurigo nodularis and atopic dermatitis. With its unique role in directly stimulating sensory neurons related to itch and contributing to inflammation and barrier dysfunction, IL-31 is the bridge between the immune and nervous systems while also directly acting on structural cells in the skin. Nemolizumab was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in December 2019 for the treatment of pruritus associated with prurigo nodularis, a status reconfirmed in February 2023.

About Galderma
Galderma 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’re in shapes our lives, we are advancing dermatology for every skin story. Galderma’s portfolio of flagship brands includes Restylane®, Dysport®, Azzalure®, Alluzience® and Sculptra® in Injectable Aesthetics; Soolantra®, Epiduo®, Differin®, Aklief®, Epsolay®, Twyneo®, Oracea®, Metvix®, Benzac® and Loceryl® in Therapeutic Dermatology; and Cetaphil® and Alastin® in Dermo-cosmetics. For more information, visit www.galderma.com.

References:

1 Williams KA, Roh YS, Brown I, et al. Pathophysiology, diagnosis, and pharmacological treatment of prurigo nodularis. Expert Rev Clin Pharmacol. 2021;14(1):67-77. doi:10.1080/17512433.2021.1852080
2 Elmariah S, Kim B, Berger T, et al. Practical approaches for diagnosis and management of prurigo nodularis: United States expert panel consensus. J Am Acad Dermatol. 2021;84(3):747-760. doi:10.1016/j.jaad.2020.07.025
3 Whang KA, Mahadevan V, Bakhshi PR, et al. Prevalence of prurigo nodularis in the United States. J Allergy Clin Immunol Pract. 2020;8(9):3240-3241. doi:10.1016/j.jaip.2020.05.051
4 Huang AH, Canner JK, Khanna R, Kang S, Kwatra SG. Real-world prevalence of prurigo nodularis and burden of associated diseases. J Invest Dermatol. 2020;140(2):480-483.e4. doi:10.1016/j.jid.2019.07.697

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

For further information:

Christian Marcoux, M.Sc.
Chief Communications Officer
christian.marcoux@galderma.com
+41 76 315 26 50

Rachel Mooney
Global Franchise Communications
rachel.mooney@galderma.com
+41 76 261 64 41

Zach Randles-Friedman
Head of U.S. Communications
Zach.Randles-Friedman@galderma.com
+1 305 299 5700

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

DC Secretary Announces Annual Determinations Committees Outcome28.3.2024 23:14:00 EET | Press release

DC Administration Services, Inc. has today announced the composition of five regional Determinations Committees (DCs), effective from April 27, 2024. Voting Dealers (for all regions): Voting Non-Dealers (for all regions): Bank of America N.A. Citadel LLC Barclays Bank plc Elliott Management Corporation BNP Paribas Pacific Investment Management Company LLC Citibank, N.A. Deutsche Bank AG Goldman Sachs International JPMorgan Chase Bank, N.A. Voting Dealer for the Americas, EMEA, AEJ, and Japan Determination Committees: Mizuho Securities Co., Ltd. The process for selecting DC members is specified in the DC rules. The DC rules, along with more information about the Determinations Committees and what they do can be found at the Determinations Committees website: https://www.cdsdeterminationscommittees.org/. View source version on businesswire.com: https://www.businesswire.com/news/home/20240328441002/en/ Contact information Press Inquiries: Orlando Figueroa orlando.figueroa@citadelspv.com

Faster Recoveries, Improved Security: HTEC and G2 Risk Solutions Join Forces to Advance Bankruptcy Management28.3.2024 19:02:00 EET | Press release

HTEC, a global digital consulting, software engineering, and product development company, is announcing a strategic collaboration with G2 Risk Solutions (G2RS), the preeminent provider of end-to-end bankruptcy technology solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240328622816/en/ HTEC & G2 Risk Solutions Partnership (Photo: Business Wire) Under the agreement, G2RS will engage HTEC to incorporate its leading-edge technology into G2RS’ premier bankruptcy management platform. As the creators of the most comprehensive national bankruptcy database and the first bankruptcy management portal, G2RS is an industry pioneer. By adding HTEC’s premium engineering to the G2RS technology stack, G2RS will offer new and innovative functionalities to help clients expedite financial recoveries, increase data protection, and reduce operational inefficiencies in the bankruptcy management life cycle. “We are thrilled to be a part o

LambdaTest Launches The Phoenix Project, an Employee Resource Group for Women28.3.2024 18:00:00 EET | Press release

LambdaTest, a leading cloud-based unified testing platform, announced the launch of The Phoenix Project, an Employee Resource Group (ERG) dedicated to supporting and promoting the success of its female employees. “LambdaTest is committed to fostering a diverse, inclusive, and equitable workplace where all employees feel valued and empowered to reach their full potential,” said Chandini Chopra, VP of People and Culture at LambdaTest. “The Phoenix Project is a critical step towards achieving this goal by providing a platform for professional development, networking, and mentorship, especially for our women employees.” The Phoenix Project Aims To: Offer professional development workshops, networking opportunities, and dedicated time off for women to participate in ERG initiatives. Provide mentorship programs connecting senior female employees with mentees. Promote leadership development among women within the company. Create a sense of community for women in the workplace. Leadership and

The reopening of the Yokohama Museum of Art adds another innovative and distinctive venue for events in Yokohama28.3.2024 18:00:00 EET | Press release

After extensive renovations, the iconic Yokohama Museum of Art has reopened its doors to visitors from all over the world. The museum’s reopening paves the way to new and closer collaboration with international events in Yokohama. This extraordinary venue is the ideal setting for a one-of-a-kind gathering, in part, supported by the Yokohama Convention & Visitors Bureau (hereinafter YCVB). The Yokohama Museum of Art Founded in 1989, the Yokohama Museum of Art collects over 14,000 works of art that reflect the many facets of life in Yokohama—past, present, and future. The reopening of the museum coincides with the Yokohama Triennale, an international exhibition featuring contemporary artists whose decentralized exhibits turn the entire metropolis into an art museum. The 8th Yokohama Triennale is being held from March 15 to June 9, 2024, with the Yokohama Museum of Art being a pivotal venue for the exhibition. With the museum firmly back on the map as Yokohama’s leading artistic venue, YC

Eight new sustainability-themed experiences—exclusive to Yokohama—for convention participants28.3.2024 18:00:00 EET | Press release

In a survey conducted by Yokohama Convention & Visitors Bureau (hereinafter YCVB), many convention attendees expressed particular interest in Yokohama’s culture, sightseeing spots, and local cuisine. In response, YCVB has developed eight new Yokohama Tours for event attendees to enjoy during their free time in Yokohama, keeping in line with our ethos of sustainability. Noge Area Bar-Hopping Tour, complete with guide Known affectionately by locals as Yokohama’s kitchen, Noge is a bustling nightlife spot that is home to over 600 izakaya (Japanese-style pubs). A knowledgeable local guide will lead participants to all the hidden gems in Noge, where they can indulge in distinctive, delicious pub-style food and drink. With easy on-foot accessibility, participants can rest assured this fun night out won’t impact their carbon footprint. Soto Zen Tour of Sojiji, head temple of the Soto Zen school As a prominent Zen sect in Japan, Soto Zen provides one of the best Zen wellness experiences. Durin

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
HiddenA line styled icon from Orion Icon Library.Eye