ICD 2025: New data demonstrate Nemluvio®'s (nemolizumab) favorable safety profile and sustained and clinically meaningful improvements in symptoms of prurigo nodularis up to two years
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An interim analysis of the OLYMPIA long-term extension study to be presented as a late-breaking abstract at the XIV International Congress of Dermatology (ICD) found that Nemluvio was well tolerated and associated with sustained and clinically meaningful improvements in the key signs and symptoms of prurigo nodularis, including both skin lesions and itch, up to two years 1
Results build on data from OLYMPIA – the largest completed pivotal clinical program in prurigo nodularis and the only one assessing long-term safety and efficacy in prurigo nodularis 1-3
This follows the presentation of data from the ARCADIA long-term extension study at the Revolutionizing Atopic Dermatitis (RAD) Conference earlier this month, which showed Nemluvio is well tolerated with sustained and increased improvements in efficacy outcomes in atopic dermatitis patients up to two years 4
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ZUG, Switzerland — Galderma (SIX: GALD) today announced data from a new interim analysis of a study investigating the long-term safety and efficacy of Nemluvio in moderate-to-severe prurigo nodularis. The new data show Nemluvio is well tolerated and associated with sustained and clinically meaningful improvements in symptoms including itch and skin lesions, during prolonged treatment up to two years. 1 These new data will be presented as a late-breaking session at ICD, on Saturday, June 21, 2025 at 08:30 AM CET.
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is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules, which have a substantial impact on patients' quality of life.
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5-7
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Nemluvio
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is the first approved monoclonal antibody that specifically targets the IL-31 receptor alpha, inhibiting the signaling of IL-31.
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8,9,10
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IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation, skin barrier dysfunction, and fibrosis in prurigo nodularis.
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8-11
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It is also the first and only biologic approved for prurigo nodularis as well as atopic dermatitis with four-week dosing intervals from the start of treatment.
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9,10
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The OLYMPIA long-term extension study was designed to assess the safety and efficacy of Nemluvio in patients with prurigo nodularis up to four years and includes 508 patients from the phase II trial or the phase III OLYMPIA 1 and 2 trials. 1 Results show that treatment with Nemluvio is associated with sustained and clinically meaningful improvements in symptoms of prurigo nodularis during prolonged treatment up to two years. 1 At Week 100 in evaluable patients, the interim analysis shows that:
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More than 90% and 70% achieved at least a four-point improvement in itch, and being itch free or nearly itch free respectively, as measured by the Peak-Pruritus Numerical Rating Scale 1
At least 80% achieved 76‑100% healed pruriginous lesions 1
Approximately 75% reached clearance or almost-clearance of skin nodules when assessed using the Investigator's Global Assessment score 1
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Nemluvio was well tolerated in the long-term treatment of prurigo nodularis and no new safety signals were identified in this study to date. 1
'These impressive results give us even more confidence in the value of nemolizumab – a much-needed innovative medicine that has the potential to deeply impact the prurigo nodularis treatment landscape. With this new treatment now approved in multiple markets including the EU and U.S., I'm thrilled to be able to see its meaningful impact in the real world.'
This follows presentation of results from the ARCADIA long-term extension study at the RAD Conference earlier this month, which showed that treatment with Nemluvio was well tolerated and associated with sustained and increased improvements in symptoms of atopic dermatitis during prolonged treatment up to two years. 4 Nemluvio was first approved in August 2024 by the United States Food and Drug Administration (U.S. FDA) for the treatment of adults with prurigo nodularis. 9 In December 2024, it was also approved by the U.S. FDA for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. 9 To date, Nemluvio is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including the European Commission. Additional reviews and submissions are ongoing.
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Galderma will also host a symposium at ICD, exploring the latest advances in addressing itch in both prurigo nodularis and atopic dermatitis. Separately, the company will share new data from across its Therapeutic Dermatology portfolio in acne, non-melanoma skin cancer, and rosacea.
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More details on Galderma's scientific presentations at ICD can be found here.
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Nemluvio
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was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. In Japan, nemolizumab is marketed as Mitchga
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®
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and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.
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12,13
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About prurigo nodularis
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Prurigo nodularis
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is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules covering large body areas.
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5-7
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It is an underrecognized and underdiagnosed skin condition, and there are limited studies investigating its prevalence.
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11,14,15
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About Galderma
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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:
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Ständer S, et a. Nemolizumab long-term efficacy and safety up to 100 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis: An interim analysis. Presented at International Congress of Dermatology; June 18-21, 2025; Rome, Italy.
ClinicalTrials.Gov. A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) (NCT04501679). Available online. Accessed May 2025
ClinicalTrials.Gov. Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) (NCT04501666). Available online. Accessed May 2025
Silverberg, JI, et al. Nemolizumab long-term safety and efficacy up to 104 weeks in the ARCADIA open-label extension study in adolescents and adults with moderate-to-severe atopic dermatitis. Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States.
Huang AH, et al. Prurigo nodularis: epidemiology and clinical features. J Am Acad Dermatol. 2020;83(6):1559-1565. doi: 10.1016/j.jaad.2020.04.183
Pereira MP, et al. European Academy of Dermatology and Venereology European prurigo project: expert consensus on the definition, classification and terminology of chronic prurigo. J Eur Acad Dermatol Venereol. 2018;32(7):1059-1065. doi: 10.1111/jdv.14570
Ständer S, et al. IFSI-guideline on chronic prurigo including prurigo nodularis. Itch. 2020;5(4):e42. doi: 10.1097/itx.0000000000000042
Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173-182. doi: 10.1016/j.jaci.2019.08.013
Nemluvio U.S. Prescribing Information. Available online. Accessed May 2025
Nemluvio European Medicines Agency. Summary of Product Characteristics. Available online. Accessed May 2025
Bewley A, et al. Prurigo Nodularis: A Review of IL-31RA Blockade and Other Potential Treatments. Dermatol Ther (Heidelb). 2022;12(9):2039–2048. doi: 10.1007/s13555-022-00782-2
Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed May 2025
Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed May 2025
Ständer S, et al. Prevalence of prurigo nodularis in the United States of America: a retrospective database analysis. JAAD Int. 2020;2:28-30. doi: 10.1016/j.jdin.2020.10.009
Huang AH, et al. 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
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Contacts
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For further information:
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Christian Marcoux, M.Sc.
Chief Communications Officer
christian.marcoux@galderma.com
+41 76 315 26 50
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Richard Harbinson
Corporate Communications Director
richard.harbinson@galderma.com
+41 76 210 60 62
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Céline Buguet
Franchises and R&D Communications Director
celine.buguet@galderma.com
+41 76 249 90 87
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Emil Ivanov
Head of Strategy, Investor Relations, and ESG
emil.ivanov@galderma.com
+41 21 642 78 12
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Article content Cybin continues to make significant progress on its journey to bring breakthrough therapies to patients by delivering on the following key milestones Article content – Received European and United Kingdom Medical and Healthcare Products Regulatory Agency ('MHRA') approval for EMBRACE, the Company's second pivotal study evaluating CYB003 for the adjunctive treatment of Major Depressive Disorder ('MDD') on schedule – Article content Article content – EMBRACE study to enroll 330 participants at approximately 60 clinical sites across Article content the United States, United Kingdom, Europe, and Australia 1 – Article content – Completion of patient enrollment in CYB004 Phase 2 study in General Anxiety Disorder expected in August 2025 1 – Article content – Recent financing agreement of US$50 million principal amount of convertible debentures will advance clinical pipeline programs – Article content – Cash totaled US$118.7 million as of June 30, 2025 – Article content This news release constitutes a 'designated news release' for the purposes of Cybin's prospectus supplement dated February 10, 2025, to its short form base shelf prospectus dated August 17, 2023, as amended December 22, 2023, April 8, 2024, and January 6, 2025. Article content TORONTO — Cybin Inc. (NYSE American:CYBN) (Cboe Canada CA:CYBN) (' Cybin ' or the ' Company '), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, today reported unaudited financial results for its first quarter ended June 30, 2025, and is pleased to provide an update on key business milestones. Article content 'With our recently announced funding agreement in place, we are well positioned to continue advancing our lead clinical programs, CYB003 and CYB004, through multiple inflection points,' said Doug Drysdale, Chief Executive Officer of Cybin. 'Gaining European CTA approval and MHRA approval to commence EMBRACE in the UK has enabled us to expand our multinational Phase 3 PARADIGM program evaluating CYB003 for the potential adjunctive treatment of major depressive disorder. PARADIGM is a significantly larger program than the completed Phase 2 study, with anticipated combined enrollment of approximately 550 participants. Our Phase 3 studies will evaluate the potential clinical benefits of CYB003 in patients living with moderate to severe MDD, and whose symptoms are uncontrolled with existing antidepressant treatment. Our Phase 2 study evaluating CYB004 in generalized anxiety disorder is expected to complete patient enrollment this month.' Article content 'Cybin is in a strong position to advance our programs and continue our work to deliver innovative therapies to address some of the most challenging mental health disorders we face today and is helping to build momentum across the sector – both from a clinical and regulatory perspective,' concluded Drysdale. Article content Recent Business and Pipeline Highlights: Article content Received European approval and MHRA approval for EMBRACE, the second Phase 3 study within the PARADIGM program evaluating CYB003 for the adjunctive treatment of MDD, on schedule. Article content The Company has received CTA approval from the Irish Medicines Board for the EMBRACE study in Ireland, Poland, and Greece, as well as approval from the MHRA. Article content Article content EMBRACE is a 12-week, randomized, double-blind, placebo-controlled study in 330 participants with moderate to severe MDD (MADRS≥24) who are on a stable dose of antidepressant medication but with inadequate response. EMBRACE will evaluate two doses of CYB003 (8 mg, 16 mg) three weeks apart, compared to an inactive placebo. The primary endpoint is change in depressive symptoms as measured by the change in MADRS from baseline six weeks after the first dose. Article content Making strong progress on CYB003 development through the APPROACH and EXTEND studies. Article content Dosing is currently ongoing in the first pivotal study, APPROACH, which is expected to enroll 220 patients across 45 U.S. clinical sites. We are pleased to report that patient rollovers continue into EXTEND, the long-term extension study. Article content Clinical Program Summary Article content CYB003 program accomplishments: Article content Received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the adjunctive treatment of MDD. A completed Phase 2 study of CYB003 in MDD demonstrated durability of effect at 12 months: 100% of participants receiving two doses of 16 mg were responders. 71% of participants receiving two doses of 16 mg were in remission. Mean change from baseline in MADRS was approximately -23 points after two 16 mg doses. Article content CYB004: Deuterated dimethyltryptamine program Article content The Phase 2 CYB004 study is a randomized, double-blind study evaluating the safety and efficacy of CYB004 in participants with generalized anxiety disorder, with concomitant antidepressant/anxiolytic treatment and co-morbid depression allowed. Patient enrollment is expected to be completed this month 1. Article content Change in Presentation Currency Article content Effective April 1, 2025, the Company changed its presentation currency from the Canadian dollar to the United States dollar (' USD '). The change in presentation currency was made to better reflect the Company's operations, align with the currency in which the majority of cash-based expenses are denominated, and improve comparability of its financial results with other publicly traded businesses in the industry. As a result, all amounts presented in this press release are in USD unless otherwise stated. Article content First-Quarter Financial Highlights Article content Cash totaled $118.7 million as of June 30, 2025. Net loss was $24.6 million for the quarter ended June 30, 2025, compared to a net loss of $10.8 million in the same period last year. Cash-based operating expenses consisting of research, general, and administrative costs totaled $23.9 million for the quarter ended June 30, 2025, compared to $11.9 million, in the same period last year. Cash flows used in operating activities were $29.5 million for the quarter ended June 30, 2025, compared to $19.9 million in the same period last year. Article content About Cybin Article content Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions. Article content With promising proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin analog, in Phase 3 studies for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a Phase 2 study for generalized anxiety disorder. The Company also has a research pipeline of investigational, 5-HT-receptor focused compounds. Article content Founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For Company updates and to learn more about Cybin, visit or follow the team on X, LinkedIn, YouTube and Instagram. Note: Article content Cautionary Notes and Forward-Looking Statements Article content Certain statements in this news release relating to the Company are forward-looking statements or forward-looking information within the meaning of applicable securities laws (collectively, 'forward-looking statements') and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as 'may', 'should', 'could', 'potential', 'possible', 'intend', 'estimate', 'plan', 'anticipate', 'expect', 'believe' or 'continue', or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the EMBRACE study to enroll 330 participants at approximately 60 clinical sites across the United States, United Kingdom, Europe, and Australia; the Company's expectation to enroll 220 participants at approximately 45 clinical sites across the United States for the APPROACH study; the Company's expectation to complete enrollment in CYB004 Phase 2 study in August 2025; the Company's expectation to receive topline data from APPROACH in 2026; and the Company's plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions. Article content These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; implications of disease outbreaks on the Company's operations; and the risk factors set out in each of the Company's management's discussion and analysis for the three months ended June 30, 2025, and the Company's annual information form for the year ended March 31, 2025, which are available under the Company's profile on SEDAR+ at and with the U.S. Securities and Exchange Commission on EDGAR at Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law. Article content Cybin makes no medical, treatment or health benefit claims about Cybin's proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin's performance and operations. Article content Article content Article content Article content Article content Contacts Article content Investor & Media Contact: Article content Article content Gabriel Fahel Article content Article content Chief Legal Officer Article content Article content Cybin Inc. Article content Article content 1-866-292-4601 Article content Article content Article content Article content
