Stomatitis, Aphthous

PRINCETON, N.J.--( BUSINESS WIRE )--Award-winning actor Ted Danson, who lives with plaque psoriasis, teams up with Bristol Myers Squibb for the inspiring “ SO, Have You Found It? ” campaign. This initiative spotlights the resilience of around two million Americans with moderate to severe plaque psoriasis, aiming to amplify their voices, underscoring the strength of their inner vibe, the “it” factor that makes someone uniquely them. i The campaign signifies a shift in dialogue from the challenges associated with the condition to empowering individuals to confidently navigate their plaque psoriasis in partnership with their dermatologists. Expanding the “Found It” Conversation “Navigating plaque psoriasis is both deeply personal and often challenging for many patients,” acknowledged Carlos Dortrait, senior vice president and general manager of U.S. Immunology and Neuroscience at Bristol Myers Squibb. “‘SO, Have You Found It?’ builds on the empowering narrative of our ‘Found It’ consumer campaign. It aims to address not just the visible skin symptoms, but also the hidden burden of the condition. Our goal is to inspire patients to talk with their dermatologists to explore treatment options that work for them and to highlight their strength, their ‘it’ factor, as they navigate their condition." Psoriasis is a chronic, systemic, immune-mediated disease that most often manifests as plaque psoriasis. i Psoriasis doesn’t just affect the skin — it starts within and can touch many aspects of your life — from dating and work to travel and fashion. Many with plaque psoriasis find themselves altering their lifestyles, sometimes avoiding social situations and personal connections. Recognizing Every Individual’s Journey “Being part of ‘SO, Have You Found It?’ hits close to home for me,” shared Ted Danson, the renowned actor known for his humor and sincerity, and someone who lives with moderate to severe plaque psoriasis. “This isn't just another role; it's a part of my life. I've dealt with the ups and downs of plaque psoriasis for decades. This campaign gives so many of us living with the condition a platform to openly share our stories and feel empowered to self-advocate and honor our identity.” A new video featuring Ted Danson was released as part of the “SO, Have You Found It?” campaign. The video focuses on the lived experiences of those with moderate to severe plaque psoriasis, blending real stories of triumph, resilience and self-advocacy, complemented by Ted's signature subtle humor. Future episodes aim to deepen the connection with viewers, offering a mix of genuine perspectives and expert insights, and capturing the multifaceted journey of living with moderate to severe plaque psoriasis. Emily, who is living with the condition and was featured in the premiere video, is being treated with SOTYKTU™ (deucravacitinib), an FDA-approved, once-daily pill for adults with moderate to severe plaque psoriasis. She shared, “The road to managing my plaque psoriasis has been hard in many aspects of my life, like in certain social situations and spending time everyday covering up my plaques. It was because of the continuous conversations with my dermatologist and advocating for my health, that I have a newfound sense of self-acceptance and empowerment. Finding a treatment that worked for me was such an important point in my life.” Please see Important Safety Information for SOTYKTU below, including serious and most common side effects. About the “SO, Have You Found It?” Campaign “SO, Have You Found It?” honors the resilience and individuality of approximately two million Americans living with moderate to severe plaque psoriasis. In partnership with Ted Danson, Bristol Myers Squibb seeks to support and uplift the community by amplifying their voices, showcasing their “it” factor, that inner vibe that makes someone uniquely them. The initiative encourages those with moderate to severe plaque psoriasis to openly discuss their condition and treatment options with their dermatologist, including whether a systemic oral treatment, like SOTYKTU, may be right for them. Learn more at SoHaveYouFoundIt.com . About SOTYKTU ™ ( deucravacitinib) SOTYKTU™ (deucravacitinib) is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit from taking pills or injections (systemic therapy) or treatment using ultraviolet or UV light (phototherapy). It is not known if SOTYKTU is safe or effective in children under 18 years of age. As the only once-daily pill of its kind, SOTYKTU selectively targets and inhibits TYK2, a molecule which plays a key role in passing signals in plaque psoriasis. It is not currently known how blocking TYK2 signals works to reduce plaque psoriasis symptoms. Of the 1684 adults in the studies, 841 received SOTYKTU, 421 received placebo, and 422 received Otezla ® (apremilast). In one study, half of the participants receiving SOTYKTU achieved clear or almost clear skin with 16 weeks of treatment compared to 9% of those on placebo. Furthermore, more than half (53%) of SOTYKTU users experienced 75% clearer skin compared to 9% of those on placebo. In the same study, 32% of people taking SOTYKTU saw 90% clearer skin vs 20% taking the leading alternative pill, Otezla. SOTYKTU may cause serious side effects, including severe allergic reactions. Patients are advised to seek immediate medical help if they exhibit symptoms of a serious allergic reaction: feel faint; swelling of your face, eyelids, lips, mouth, tongue or throat; trouble breathing or throat tightness; chest tightness; skin rash, hives. The most common side effects of SOTYKTU include common cold, sore throat and sinus infection, cold sores, canker sores on inner lips, gums, tongue, or roof of the mouth, inflamed hair pores and acne. These are not all of the possible side effects of SOTYKTU. See additional Important Safety Information below. For complete safety information and detailed prescribing guidelines, the U.S. Full Prescribing Information and Medication Guide for SOTYKTU are available. About Ted Danson Ted Danson, acclaimed actor and comedian, known for his roles in Cheers and The Good Place , lends his voice to the “SO, Have You Found It?” campaign as an advocate for those living with plaque psoriasis. Through his involvement, Ted aims to inspire conversations between dermatologists and patients, and celebrate the unique journeys of individuals managing plaque psoriasis. Ted is not taking SOTYKTU. About Plaque Psoriasis Psoriasis is a widely prevalent, chronic, systemic immune-mediated disease that substantially impairs patients’ physical health, quality of life and work productivity. ii Psoriasis is a serious global problem, with at least 100 million people worldwide impacted by some form of the disease, iii including approximately 7.5 million people in the U.S. i Nearly one-quarter of people with psoriasis have cases that are considered moderate to severe. i Up to 90 percent of patients with psoriasis have psoriasis vulgaris, or plaque psoriasis, iv which is characterized by distinct round or oval plaques typically covered by silvery-white scales. v INDICATION AND IMPORTANT SAFETY INFORMATION INDICATION SOTYKTU ™ (deucravacitinib) is a prescription medicine used to treat adults with moderate-to-severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy). It is not known if SOTYKTU is safe and effective in children under 18 years of age. IMPORTANT SAFETY INFORMATION about SOTYKTU (deucravacitinib) SOTYKTU may cause serious side effects, including: Serious allergic reactions. Stop taking SOTYKTU and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction: feel faint swelling of your face, eyelids, lips, mouth, tongue, or throat trouble breathing or throat tightness chest tightness skin rash, hives Infections. SOTYKTU is a medicine that affects your immune system. SOTYKTU can lower the ability of your immune system to fight infections and can increase your risk of infections. Some people have had serious infections while taking SOTYKTU, such as infections of the lungs, including pneumonia and tuberculosis (TB), and COVID-19. Your healthcare provider should check you for infections and TB before starting treatment with SOTYKTU and watch you closely for signs and symptoms of TB during SOTYKTU treatment. You may be treated for TB before you begin SOTYKTU treatment if you have a history of TB or have active TB. If you get a serious infection, your healthcare provider may tell you to stop taking SOTYKTU until your infection is controlled. SOTYKTU should not be used in people with an active, serious infection, including localized infections. You should not start taking SOTYKTU if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). Before starting SOTYKTU, tell your healthcare provider if you: are being treated for an infection, or have had an infection that does not go away or keeps coming back have TB or have been in close contact with someone with TB have or have had hepatitis B or C think you have an infection or have symptoms of an infection such as: fever, sweats, or chills muscle aches weight loss cough shortness of breath blood in your phlegm (mucus) warm, red, or painful skin or sores on your body different from your psoriasis diarrhea or stomach pain burning when you urinate or urinating more often than normal feeling very tired After you start taking SOTYKTU, call your healthcare provider right away if you have an infection or have symptoms of an infection. SOTYKTU can make you more likely to get infections or make any infections you have worse. Cancer. Certain kinds of cancer including lymphoma have been reported in people taking SOTYKTU. Tell your healthcare provider if you have ever had any type of cancer. Muscle problems (rhabdomyolysis). SOTYKTU can cause muscle problems that can be severe. Treatment with SOTYKTU may increase the level of an enzyme in your blood called creatine phosphokinase (CPK) and can be a sign of muscle damage. Increased CPK is common in people taking SOTYKTU. Your healthcare provider may tell you to stop taking SOTYKTU if the amount of CPK in your blood gets too high or if you have signs and symptoms of severe muscle problems. Tell your healthcare provider right away if you have any of these signs or symptoms of severe muscle problems: unexplained muscle pain, tenderness, or weakness, feeling very tired, fever, or dark-colored urine. Do not take SOTYKTU if you are allergic to deucravacitinib or any of the ingredients in SOTYKTU. Before taking SOTYKTU, tell your healthcare provider about all of your medical conditions, including if you: have liver problems or kidney problems, have high levels of fat in your blood (triglycerides), or have recently received or are scheduled to receive an immunization (vaccine), as you should avoid receiving live vaccines during treatment with SOTYKTU. Tell your healthcare provider if you are pregnant, plan to become pregnant, or if you are breastfeeding or plan to breastfeed. It is not known if SOTYKTU can harm your unborn baby or if SOTYKTU passes into your breast milk. Report pregnancies to the Bristol Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072. Tell your healthcare provider about all the medicines you take , including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Take SOTYKTU exactly as your healthcare provider tells you to take it. Take SOTYKTU 1 time every day, with or without food. Do not crush, cut, or chew the SOTYKTU tablets. SOTYKTU may cause serious side effects, including : Changes in certain laboratory test results. Changes in laboratory tests have happened in some people taking SOTYKTU. Your healthcare provider may do blood tests before you start taking SOTYKTU and during treatment with SOTYKTU to check for the following: Increased triglycerides. Too much fat in your blood can cause problems with your heart. Increased liver enzymes. If your liver enzymes increase too much, your healthcare provider may need to do additional tests on your liver and may tell you to stop taking SOTYKTU if they think that SOTYKTU is harming your liver. Potential risks from Janus kinase (JAK) inhibition. SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor. TYK2 is in the JAK family. It is not known whether taking SOTYKTU has the same risks as taking JAK inhibitors. Increased risk of death (all causes) has happened in people who were 50 years of age and older with at least 1 heart disease (cardiovascular) risk factor who were taking a JAK inhibitor used to treat rheumatoid arthritis (RA) compared to people taking another medicine in a class of medicines called TNF blockers. SOTYKTU is not for use in people with RA . The most common side effects of SOTYKTU include: common cold, sore throat and sinus infection (upper respiratory infections), cold sores (herpes simplex), sores on inner lips, gums, tongue, or roof of the mouth (canker sores), inflamed hair pores (folliculitis) and acne. These are not all of the possible side effects of SOTYKTU. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please see the U.S. Full Prescribing Information and Medication Guide for SOTYKTU. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , Twitter , YouTube , Facebook and Instagram. corporatefinancial-news i Armstrong AW, Mehta MD, Schupp CW, et al. Psoriasis prevalence in adults in the United States. JAMA Dermatol. Published online June 30, 2021. doi:10.1001/jamadermatol.2021.2007. ii Armstrong AW, Schupp C, Wu J, Bebo B. Quality of life and work productivity impairment among psoriasis patients: findings from the National Psoriasis Foundation survey data 2003–2011. PloS One. 2012;7(12):e52935. iiI World Health Organization. Global report on psoriasis. 2016. Accessed May 12, 2022. https://apps.who.int/iris/bitstream/handle/10665/204417/9789241565189_eng.pdf.psoriasis?sequence=1 iv Menter A, Gottlieb A, Feldman SR, Van Voorhees AS et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008 May;58(5):826-50. v Nair PA, Badri T. Psoriasis. [Updated 2023 Apr 3]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK448194/

PRINCETON, N.J., March 15, 2024 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the year ended December 31, 2023. "Our primary focus in 2024 continues to be advancing our multiple clinical programs in our rare disease pipeline," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Our collaborative discussions continue with the U.S. Food and Drug Administration (FDA) regarding the design of a second, confirmatory Phase 3 pivotal study evaluating HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL), where we successfully demonstrated statistically significant results in the first Phase 3 clinical trial. We also continue to engage in discussions with the European Medicines Agency to explore potential marketing approval and partnership in Europe. Recently, we shared successful preliminary top-line results of our ongoing Phase 2a clinical trial of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis. Following the clearance of the Investigational New Drug (IND) application for a Phase 2a clinical trial with SGX945 (dusquetide) in Behçet's Disease and the recent receipt of "Fast Track" designation from the FDA, we anticipate initiating this study in the second half of 2024. Under our Public Health Solutions business segment, we recently announced publication of the preclinical efficacy of a novel, single-vial, bivalent vaccine providing 100% protection against both Sudan ebolavirus (SUDV) and Marburg marburgvirus (MARV) infections. The published paper describes the potency of the bivalent formulation against both lethal viruses, demonstrating 100% protection in the most rigorous non-human primate (NHP) challenge models." Dr. Schaber continued, "With approximately $8.4 million in cash at December 31, 2023, not including our non-dilutive government funding, we are managing cash burn very carefully in order to achieve our near-term milestones. We recently received $0.6 million, net of transaction costs, from the state of New Jersey's (NJ) Technology Business Tax Certificate Transfer Program. This is our fourteenth year participating in the program, over that time we have received approximately $9.4 million in non-dilutive capital. We continue to evaluate a number of strategic options, including but not limited to, partnership and merger and acquisition opportunities." Soligenix Recent Accomplishments On February 8, 2024, the Company announced the formation of a Medical Advisory Board to provide medical/clinical strategic guidance to the Company as it advances the clinical development of SGX945 (dusquetide) for the treatment of Behçet's Disease. To view this press release, please click here. On January 8, 2024, the Company announced its SGX945 development program for the treatment of oral lesions of Behçet's Disease has received "Fast Track" designation from the FDA. To view this press release, please click here. On January 4, 2024, the Company announced positive preliminary top-line results of its ongoing Phase 2a trial of SGX302 for the treatment of mild-to-moderate psoriasis. To view this press release, please click here. On January 2, 2024, the Company announced publication describing the preclinical efficacy of a novel, single-vial, bivalent vaccine providing 100% protection against both SUDV and MARV infections in NHP models. This vaccine candidate had been previously demonstrated to be stable to high temperature storage for at least 2 years at 40 degrees Celsius (104 degrees Fahrenheit). To view this press release, please click here. On December 1, 2023, the Company announced publication of an article describing the potential use of HyBryte™ in the treatment of CTCL in Frontiers in Drug Discovery. To view this press release, please click here. On November 30, 2023, the Company announced the FDA had cleared the IND application for a Phase 2a clinical trial entitled, "Pilot Study of SGX945 (Dusquetide) in the Treatment of Aphthous Ulcers in Behçet's Disease." To view this press release, please click here. Financial Results – Year Ended December 31, 2023 Soligenix's revenues for the year ended December 31, 2023 was $0.8 million as compared to $0.9 million for the year ended December 31, 2022. Revenues primarily relate to government contracts and grants awarded in support of HyBryte™, our therapeutic candidate for early-stage CTCL; SGX943, our therapeutic candidate for treatment of emerging and/or antibiotic-resistant infectious diseases; and CiVax™, our vaccine candidate for the prevention of COVID-19. Soligenix's net loss was $6.1 million, or ($0.79) per share, for the year ended December 31, 2023, as compared to $13.8 million, or ($4.81) per share, for the year ended December 31, 2022. The decrease in net loss was primarily due to decreases in operating expenses and interest expense and an increase in other income. Research and development expenses were $3.3 million as compared to $7.9 million for the years ended December 31, 2023 and 2022, respectively. The decrease was primarily due to the decrease in manufacturing and regulatory costs associated with the HyBryte™ new drug application filing. General and administrative expenses were $4.5 million and $6.7 million for the years ended December 31, 2023 and 2022, respectively. This decrease in general and administrative expenses is primarily attributable to a reduction in legal and consulting expenses. As of December 31, 2023, the Company's cash position was approximately $8.4 million. About Soligenix, Inc. Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, and our first-in-class innate defense regulator (IDR) technology, dusquetide for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer (SGX942) and in Behçet's Disease (SGX945). Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg, Sudan and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA). For further information regarding Soligenix, Inc., please visit the Company's website at and follow us on LinkedIn and Twitter at @Soligenix_Inc. This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, and include the expected amount and use of proceeds from the offering and the expected closing date of the offering. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of any of its clinical/preclinical trials. Despite the statistically significant result achieved in the HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful. Notwithstanding the result in the HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma and the Phase 2a clinical trial of SGX302 for the treatment of psoriasis, there can be no assurance as to the timing or success of the clinical trials of SGX302 for the treatment of psoriasis. Despite the positive efficacy results demonstrated in the Phase 2 and 3 clinical studies of SGX942 for the treatment of oral mucositis due to chemoradiation therapy for head and neck cancer, there can be no assurance as to the timing or success of the clinical trials of SGX945 for the treatment of Behçet's Disease. Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission (the "SEC"), including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events. SOURCE SOLIGENIX, INC.

PRINCETON, N.J. and TOKYO, March 8, 2024 /PRNewswire/ -- Kyowa Kirin Co., Ltd. (TSE: 4151) today announced that post-hoc analysis data from the Phase 2b study of rocatinlimab (AMG 451/KHK4083), an investigational product in patients with moderate-to-severe atopic dermatitis (msAD), will be presented at the American Academy of Dermatology (AAD) 2024 Annual Meeting to be held in San Diego from March 8-12, 2024. Atopic Dermatitis (AD), a chronic, heterogeneous, inflammatory disease characterized by skin redness, pruritus, and pain, is driven by skin barrier disruption and T cell–dependent inflammatory pathways; the relative contribution of different inflammatory pathways in driving disease can vary across populations and within individuals over time. Patients with msAD continue to need additional treatment options due to ongoing symptoms like pruritis. Thus, there remains a need for therapeutic options that can deliver benefits across a heterogeneous AD patient population. e-poster: Rocatinlimab Significantly Improves Clinical Responses in Patients with Moderate-to-Severe Atopic Dermatitis by Week 2 in a Randomized Double-Blind Placebo-Controlled Phase 2b Study, will be available starting Friday, March 8. Author: Emma Guttman- Yassky, MD, PhD et al A multicenter, randomized, double-blind, placebo-controlled Phase 2b trial (NCT03703102) evaluated rocatinlimab for msAD. Primary endpoint achievement (Week 16 Eczema Area and Severity Index [EASI]) has been presented. Randomized patients (1:1:1:1:1) received subcutaneous rocatinlimab 150mg/600mg every 4 weeks (Q4W) or 300mg/600mg every 2 weeks (Q2W) for 36 weeks, or placebo (Weeks 0–18) followed by rocatinlimab (600mg Q2W Weeks 18–36). All cohorts had 20-week off-treatment follow-up. The current post-hoc analysis (267 patients; rocatinlimab: n=210, placebo: n=57) of the phase 2b study evaluated EASI and pNRS between baseline and week 16 to investigate early clinical response. Difference in least squares mean of percent change from baseline between rocatinlimab cohorts and placebo were assessed. The post hoc analysis showed statistically significant improvement in pNRS scores for patients in the treatment arms compared to placebo. Pruritis improved with rocatinlimab by Week 2 in all cohorts (−18.40% to −21.96%; p≤0.018) except 600mg Q4W (−9.66%; p=0.208), and in all cohorts by Week 4 (−15.70% to −27.19%; p≤0.045); EASI improvements vs. placebo were significant in all rocatinlimab cohorts by Week 6 (−20.50% to −32.13%; p≤0.001), and the 300mg & 600mg Q2W cohorts by Week 2 (−13.27% and −13.66%; p≤0.028). Further improvements vs. placebo continued to Week 16; improvements vs. baseline continued in all active cohorts to Week 36 and were maintained for 20 weeks off-treatment. Adverse events reported were generally similar between rocatinlimab groups. Common adverse events during the double-blind period included fever, chills, headache, aphthous ulcers and nausea. An Amgen & Kyowa Kirin co-sponsored symposium: From Heterogeneity Comes New Insights: Exploring the role of T Cells and OX40 in Atopic Dermatitis Presenters: Chih-ho Hong, MD, Clinical Assistant Professor at the University of British Columbia Raj Chovatiya, MD, PhD, Assistant Professor of Dermatology at the Northwestern University Feinberg School of Medicine in Chicago, Illinois Date: Saturday, March 9th, 11:15 am Location: Exhibit Hall, Theater 2 About rocatinlimab Rocatinlimab (AMG 451/KHK4083), an investigational product, is a potential first-in-class anti-OX40 monoclonal antibody that is being studied for its ability to inhibit and reduce the number of OX40+ pathogenic T cells responsible for driving systemic and local AD inflammatory responses. 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. The initial antibody was discovered in collaboration between Kyowa Kirin US Research and La Jolla Institute for Immunology. 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: . SOURCE Kyowa Kirin