MEDI-6469

Rocatinlimab Met Co-Primary Endpoints of vIGA-ADTM 0/1 with a ≥ 2-Point Reduction from Baseline, EASI-75, and All Key Secondary Endpoints HORIZON is the First of Eight Phase 3 Trials in the ROCKET Program TOKYO, Sept. 25, 2024 /PRNewswire/ -- Kyowa Kirin Co., Ltd. (Kyowa Kirin) (TSE:4151) (President and CEO: Masashi Miyamoto) announced top-line results of the Phase 3 ROCKET HORIZON trial of rocatinlimab, an investigational therapy targeting the OX40 receptor. HORIZON met its co-primary endpoints: achievement of a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-ADTM) score of 0 (clear) or 1 (almost clear) with a ≥ 2-point reduction from baseline [19.3% rocatinlimab vs. 6.6% placebo (12.8% difference, p<0.001)] and achievement of ≥ 75% reduction from baseline in Eczema Area and Severity Index score (EASI-75) [32.8% rocatinlimab vs. 13.7% placebo (19.1% difference, p<0.001)], both at week 24. The trial also met the revised Investigator Global Assessment (rIGA 0/1) *[1], a more stringent measure of efficacy than vIGA 0/1 based on a narrower definition of 1 (almost clear), at week 24 [16.4% rocatinlimab vs. 4.9% placebo (11.5% difference, p<0.001)]. HORIZON is a Phase 3, 24-week, randomized, placebo-controlled, double-blind study to assess the efficacy, safety and tolerability of rocatinlimab monotherapy in adults with moderate to severe atopic dermatitis (eczema). HORIZON is one of eight studies in the global ROCKET Phase 3 clinical trial program. The study also reached statistically significant differences from placebo for all key secondary endpoints, which include measurements of skin clearance (vIGA 0/1 and EASI-75 at week 16 and EASI-90 at week 24), the Pruritus Numeric Rating Scale, Atopic Dermatitis Skin Pain Scale, Dermatology Quality of Life Index, and severity scores of hand atopic dermatitis and facial atopic dermatitis. Overall safety findings in ROCKET HORIZON were comparable to those seen in the Phase 2b study. 1 "We are very pleased to have achieved statistically significant efficacy results over placebo which are consistent for co-primary endpoints and all key secondary endpoints. We look forward to further demonstrating that rocatinlimab, a potential T-cell rebalancing therapy, may help patients with moderate to severe atopic dermatitis as a new therapeutic option. We anticipate getting additional data from the ROCKET program and fully understanding the value rocatinlimab can deliver to patients." said Takeyoshi Yamashita, Ph.D., senior managing executive officer and chief medical officer at Kyowa Kirin. Detailed results of HORIZON will be provided at a future medical congress. Amgen and Kyowa Kirin plan to review HORIZON and forthcoming results from the other seven studies in the ROCKET program as part of ongoing discussions with global regulatory authorities. The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies. ROCKET HORIZON and the ROCKET Phase 3 Program ROCKET HORIZON is a Phase 3, randomized, placebo-controlled, double-blind trial assessing the efficacy, safety and tolerability of rocatinlimab monotherapy in adults with moderate to severe atopic dermatitis. The trial includes 726 adult patients who were randomized to receive rocatinlimab or placebo administered through a subcutaneous injection every four weeks for 24 weeks with a loading dose at week two.2 Key endpoints were assessed at week 16 and week 24. Co-primary endpoints for the trial are achievement of a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-ADTM) score of 0 (clear) or 1 (almost clear) with a ≥ 2-point reduction from baseline at week 24 and achievement of ≥ 75% reduction from baseline in Eczema Area and Severity Index score (EASI-75) at week 24. (In the US, revised Investigator Global Assessment (rIGA) replaces vIGA as co-primary endpoint). Key secondary endpoints assess the impact of rocatinlimab on itch, sleep, and quality of life as well as safety and tolerability. ROCKET is a comprehensive, global Phase 3 clinical trial program comprised of eight studies intended to establish the safety and efficacy profile of rocatinlimab in adults and adolescents with moderate to severe atopic dermatitis (AD) as well as multiple dosing regimens. About Moderate to Severe Atopic Dermatitis Atopic dermatitis, the most common form of eczema, is a chronic inflammatory disease that causes excessively dry, itchy skin that can be painful.3,4 People with moderate to severe atopic dermatitis experience chronic symptoms, intensified by unpredictable flare-ups that can be painful and disruptive to everyday life.4 Almost half of these patients report severe itching, leading to repeated scratching which can cause the skin to thicken and become vulnerable to infection.5,6,7 Atopic dermatitis (all severities) affects 15-20% of children and up to 10% of adults.8 T-cell imbalance is a root cause of atopic dermatitis, contributing to clinical manifestations including the disease's recurring, unpredictable symptoms.9 About Rocatinlimab Rocatinlimab is an anti-OX40 human monoclonal antibody being investigated for the treatment of moderate to severe atopic dermatitis. Rocatinlimab has the potential to be the first and only T-cell rebalancing therapy that inhibits and reduces pathogenic T cells by targeting the OX40 receptor. OX40 is a co-stimulatory receptor responsible for driving systemic and local inflammatory responses in atopic dermatitis and other conditions.9 It has been reported that effector T cells expressing OX40 are present in the lesions of patients with atopic dermatitis and are critical in the disease pathophysiology.10,11 Rocatinlimab is also being studied for moderate to severe uncontrolled asthma, prurigo nodularis and potentially other conditions where T-cell imbalance is a root cause of inflammation. The initial antibody was discovered in collaboration between Kyowa Kirin and La Jolla Institute for Immunology. Rocatinlimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by the U.S. FDA or any other regulatory authority. Amgen and Kyowa Kirin Collaboration On June 1, 2021, Kyowa Kirin and Amgen entered into an agreement to jointly develop and commercialize rocatinlimab. Under the terms of the agreement, Amgen will lead the development, manufacturing, and commercialization for KHK4083/AMG 451 for all markets globally, except Japan, where Kyowa Kirin will retain all rights. If approved, the companies will co-promote the asset in the United States and Kyowa Kirin has opt-in rights to co-promote in certain other markets including Europe and Asia. About Kyowa Kirin Kyowa Kirin aims to discover and deliver novel medicines and treatments with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients with high unmet medical needs, such as bone & mineral, intractable hematological diseases/hemato oncology, and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites us across the globe. You can learn more about the business of Kyowa Kirin at: . References Guttman-Yassky, E., Simpson, E. L., Reich, K., Kabashima, K., Igawa, K., Suzuki, T., Mano, H., Matsui, T., Esfandiari, E., Furue, M. (2023). An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: a multicentre, double-blind, placebo-controlled phase 2b study. The Lancet, 401(10372), 204–214. doi: 10.1016/S0140-6736(22)02037-2. PMID: 36509097 Amgen. A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET HORIZON). ClinicalTrials.gov identifier: NCT05651711. Updated June 4, 2024. Accessed June 27, 2024. . Wang X, et al. Medicine (Baltimore). 2017;96:e6317 Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70(2):338-351. "Eczema Stats." National Eczema Association, 5 Sept. 2023, nationaleczema.org/research/eczema-facts/. "Can Anything Relieve Severe Atopic Dermatitis?" American Academy of Dermatology, . Accessed 23 Sept. 2024. "What Is Moderate to Severe Eczema?" Allergy & Asthma Network, 16 May 2024, allergyasthmanetwork.org/what-is-eczema/moderate-to-severe-eczema/. Accessed 23 Sept. 2024. Ständer, M.D. Atopic Dermatitis. The New England Journal of Medicine. 2021. Agrawal R, Wisniewski JA, Woodfolk JA. The role of regulatory T cells in atopic dermatitis. Curr Probl Dermatol. 2011;41:112-124. doi: 10.1159/000323305. Epub 2011 May 12. PMID: 21576952; PMCID: PMC4547455. Croft M, Esfandiari E, Chong C, Hsu H, Kabashima K, Kricorian G, Warren RB, Wollenberg A, Guttman-Yassky E. OX40 in the Pathogenesis of Atopic Dermatitis-A New Therapeutic Target. Am J Clin Dermatol. 2024 May;25(3):447-461. doi: 10.1007/s40257-023-00838-9. Epub 2024 Jan 18. Erratum in: Am J Clin Dermatol. 2024 May;25(3):463. doi: 10.1007/s40257-024-00850-7. PMID: 38236520; PMCID: PMC11070399. Furue M, Furue M. OX40L-OX40 Signaling in Atopic Dermatitis. J Clin Med. 2021 Jun 11;10(12):2578. doi: 10.3390/jcm10122578. PMID: 34208041; PMCID: PMC8230615. SOURCE Kyowa Kirin WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Share EADV: New data reinforce Sanofi’s innovative approach and leadership across immune-mediated skin diseases 24 abstracts for Dupixent, including 4 oral presentations, highlight impact of targeting interleukin-4 (IL4) and interleukin-13 (IL13) across atopic dermatitis (AD), prurigo nodularis (PN) and chronic spontaneous urticaria (CSU) New data show impact of Dupixent on potential for clinical remission in children as young as six years of age with moderate-to-severe AD 15 abstracts for immunology pipeline molecules, including phase 2 presentations in AD for amlitelimab, an OX40-ligand monoclonal antibody Paris, September 25, 2024. Sanofi will present 39 abstracts across approved and pipeline medicines at the 2024 European Academy of Dermatology and Venereology (EADV) medical meeting from September 25-28 in Amsterdam, the Netherlands. Presentations will include 21 abstracts for Dupixent (dupilumab) in partnership with Regeneron, highlighting the impact of targeting IL4 and IL13 across three chronic skin conditions, including disease remission data and long-term data in children with moderate-to-severe atopic dermatitis (AD), and rapid results in adults with prurigo nodularis (PN). In addition, data presentations from Sanofi’s extensive immunology pipeline include oral and poster presentations for amlitelimab, an OX40-ligand monoclonal antibody, demonstrating safety and efficacy results in moderate-to-severe AD, as well as in poster presentations for rilzabrutinib, a novel oral BTK inhibitor, showing its impact on symptoms of AD and moderate-to-severe chronic spontaneous urticaria (CSU). Dietmar Berger, M.D., Ph.D. Chief Medical Officer, Global Head of Development at Sanofi “Our data at EADV highlight the breadth of our diverse and novel approach across inflammatory dermatologic conditions, including AD, PN and CSU. Dupixent data demonstrates the potential benefit of important treatment goals such as clinical remission and the speed and durability of efficacy. We continue to evaluate Dupixent’s real-world safety profile and consistency of patient impact and satisfaction in children, adolescents, and adults with atopic dermatitis across the globe. Additionally, we are excited to share new data from our pipeline, including results for amlitelimab showing the potential to provide durable efficacy that may enable a quarterly dosing interval, with favorable safety profile.” Notable presentations include: Dupixent New results and analyses for Dupixent in children and adults with moderate-to-severe AD and adults with prurigo nodularis. Atopic dermatitis multiple poster presentations will show results in children with moderate-to-severe AD, including those from an open-label extension study on clinical remission in children aged six to 17 years of age, including after stopping treatment with Dupixent, as well as long-term efficacy and safety data for up to two years on children aged six months to five years. Additionally, real-world data in children six months to 11 years of age will show patient-reported disease severity and health-related quality of life outcomes throughout one year. an oral presentation will show real-world safety data from around the world for Dupixent in adults and adolescents with moderate-to-severe AD. Prurigo nodularis PRIME and PRIME2: an oral presentation will show new analyses on disease activity, itch, and skin clearance as early as two weeks from two pivotal clinical studies. The safety results of these studies were generally consistent with the known safety profile of Dupixent in its approved dermatological indications. Dermatology pipeline Data include new results and analyses for amlitelimab, an OX40-ligand monoclonal antibody, in AD, and rilzabrutinib, a novel oral BTK inhibitor, in AD and CSU. Atopic dermatitis amlitelimab: six presentations will share data for amlitelimab in moderate-to-severe AD, including an oral presentation of 68-week safety results. Additional presentations highlight a PK model that support the potential use of a quarterly dosing regimen, a post-hoc analysis showing the impact of amlitelimab on AD of the head and neck, and results from an in vitro analysis demonstrating that the anti-OX40L mechanism of amlitelimab does not deplete T cells. rilzabrutinib: a poster presentation will show the impact of rilzabrutinib on itch in adults with moderate-to-severe AD. Chronic spontaneous urticaria rilzabrutinib: three poster presentations will show the impact of rilzabrutinib on itch, hives and urticaria in adults with moderate-to-severe CSU. Hidradenitis suppurativa three poster presentations will show the impact of disease symptoms on patients with hidradenitis suppurativa and highlight the need for increased disease awareness and effective treatment options. Alopecia areata a poster presentation will show conceptual model and clinical outcome measures in alopecia areata based on the patient experience. Amlitelimab and rilzabrutinib are investigational medicines for which safety and efficacy have not been evaluated by any regulatory authority. Complete list of EADV 2024 presentations: About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Sanofi Media RelationsSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.comEvan Berland | + 1 215 432 0234 | evan.berland@sanofi.comVictor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.comTimothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com Sanofi Investor RelationsThomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.comAlizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.comArnaud Delépine | + 33 6 73 69 36 93 |arnaud.delepine@sanofi.comFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.comKeita Browne | + 1 781 249 1766 | keita.browne@sanofi.comNathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.comTarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.comThibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com Sanofi Forward-Looking StatementsThis media update contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi group. Attachment Media Update Share By clicking “Accept All”, you agree to the storing of cookies on your device to enhance site navigation, measure site performance and show you personalized advertising. Please note your consent may be valid for other websites. You can personalize or withdraw your consent at any moment by clicking on the link "Cookies Settings". 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