Psoriasis of scalp

- Data from multiple Phase 1b studies in inflammatory skin conditions demonstrate durable dose-dependent improvements in physician-assessed disease activity and patient-reported outcomes - - Biomarker analyses demonstrate plurality of Treg-mediated pathways with potential effect on tissue resident memory T cell populations resulting in sustained efficacy seen in the antigen challenged mouse model and in clinical trials - SAN FRANCISCO, Oct. 29, 2024 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR), today announced the publication of peer-reviewed data from two Phase 1b studies in Nature Communications highlighting the efficacy, safety, and tolerability of rezpegaldesleukin in patients with atopic dermatitis (AD) and psoriasis (PsO). Rezpegaldesleukin is a first-in-class interleukin-2 receptor (IL-2R) agonist that enhances the activity of regulatory T cells (Tregs) with promising dose-dependent clinical activity across multiple physician-assessed and patient-reported endpoints for AD and PsO. Results from the Phase 1b studies showed that rezpegaldesleukin safely and dose-dependently increased Tregs and rapidly improved measurable exploratory disease outcomes that are largely durable for at least 36 weeks after ceasing treatment. "These promising findings clinically validate, for the first time, the Treg hypothesis – that restoring Treg function through a central pathway of IL‑2R-driven Treg rescue can have disease remittive potential across a variety of chronic inflammatory skin diseases," said Jonathan Silverberg, M.D., Ph.D., Professor of Dermatology at George Washington University School of Medicine and lead study author. "Newer evidence suggests that diseases like atopic dermatitis are not exclusively Th2-mediated. These results show that rezpegaldesleukin can act on multiple disease-driving pathways and is uniquely poised to address a diversity of immunopathologies." "The exciting clinical cross-indication efficacy here is buttressed by serum biomarker analysis demonstrating that rezpegaldesleukin can modulate multiple immunoregulatory pathways to provide rapid onset and duration of efficacy" said Jonathan Zalevsky, Ph.D., Chief Research & Development Officer at Nektar. "These findings further validate our therapeutic approach of using a Treg stimulator to dampen inflammatory responses and simultaneously restore immune balance in patients with chronic inflammatory skin diseases. We look forward to reporting topline data next year from our two Phase 2b rezpegaldesleukin studies in atopic dermatitis and alopecia areata." Key findings are summarized below: Rezpegaldesleukin was evaluated in two randomized, double-blind, placebo-controlled Phase 1b trials in patients with moderate-to-severe atopic dermatitis (AD) (NCT04081350) or chronic plaque psoriasis (PsO) (NCT04119557) Rezpegaldesleukin is safe and well-tolerated and demonstrates consistent pharmacokinetics in participants receiving subcutaneous doses of 10 to 12 μg/kg or 24 μg/kg once every 2 weeks for 12 weeks, meeting the primary and secondary objectives of each study AD patients receiving high dose rezpegaldesleukin demonstrate an 83% improvement in EASI score after 12 weeks of treatment EASI improvement of ≥ 75% (EASI-75) and vIGA-AD responses are maintained for 36 weeks after treatment discontinuation in 71% and 80% of week 12 responders, respectively The clinical improvements are accompanied by sustained increases in CD25bright Tregs Serum proteomic biomarkers demonstrated rezpegaldesleukin's ability to engage multiple immunoregulatory mechanisms to facilitate immune homeostasis, which may indicate a potential mechanism of attenuating Th1, Th2, and Th17 responses by restoring the balance of Tregs. Results validate the role of IL-2-induced Treg proliferation and activation in the AD treatment paradigm, and support the advancement of rezpegaldesleukin in the Phase 2b study in AD. The delayed-type hypersensitivity (DTH) mouse model and the profound reduction in serum IL-15 levels in atopic dermatitis patients treated with rezpegaldesleukin provides mechanistic insight for the durable efficacy that persists for months following treatment The full citation of this article can be accessed at: . About Rezpegaldesleukin Autoimmune and inflammatory diseases cause the immune system to mistakenly attack and damage healthy cells in a person's body. A failure of the body's self-tolerance mechanisms enables the formation of the pathogenic T lymphocytes that conduct this attack. Rezpegaldesleukin is a potential first-in-class resolution therapeutic that may address this underlying immune system imbalance in people with many autoimmune and inflammatory conditions. It targets the interleukin-2 receptor complex in the body in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, rezpegaldesleukin may act to bring the immune system back into balance. Rezpegaldesleukin is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases. It is wholly-owned by Nektar Therapeutics. About Nektar Therapeutics Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments that address the underlying immunological dysfunction in autoimmune and chronic inflammatory diseases. Nektar's lead product candidate, rezpegaldesleukin (REZPEG, or NKTR-358), is a novel, first-in-class regulatory T cell stimulator being evaluated in two Phase 2b clinical trials, one in atopic dermatitis and one in alopecia areata. Our pipeline also includes a preclinical candidate NKTR-0165, which is a bivalent tumor necrosis factor receptor type II agonist antibody. Nektar, together with various partners, is also evaluating NKTR-255, an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer, in several ongoing clinical trials. Nektar is headquartered in San Francisco, California. For further information, visit and follow us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements which can be identified by words such as: "will," "can," "expect," "develop," "potential," "advance," "anticipate," and similar references to future periods. Examples of forward-looking statements include, among others, statements regarding the therapeutic potential of, and future development plans for rezpegaldesleukin. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the therapeutic potential of rezpegaldesleukin are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) rezpegaldesleukin is an investigational agent and continued research and development for this drug candidate is subject to substantial risks, including negative safety and efficacy findings in future clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) rezpegaldesleukin is in clinical development and the risk of failure is high and can unexpectedly occur at any stage prior to regulatory approval; (iv) the timing of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to challenges caused by regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (v) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vi) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 9, 2024. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Contact: For Investors: Vivian Wu of Nektar Therapeutics 628-895-0661 SOURCE Nektar Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Bristol Myers Squibb (BMS) has announced positive results from a phase 3b/4 study of its oral TYK2 inhibitor Sotyktu (deucravacitinib) in moderate-to-severe scalp psoriasis. Data from the ongoing PSORIATYK SCALP trial, which included patients with less extensive overall psoriasis, were presented at this year’s European Academy of Dermatology and Venereology Congress. The primary endpoint was met, with more than three times as many patients achieving a scalp-specific Physician’s Global Assessment response of zero or one (clear/almost clear) at week 16 compared to those on placebo, at 48.5% versus 13.7%, respectively. Key secondary endpoints were also met at week 16, with a significantly higher percentage of patients achieving at least a 90% improvement in Psoriasis Scalp Severity Index response and a change from baseline in scalp-specific itch with Sotyktu treatment compared with placebo. At least 100 million people worldwide are affected by psoriasis, an immune-mediated disease that causes inflammation in the body. Scalp psoriasis occurs in approximately 80% of patients with plaque psoriasis, the most common form of the condition, and is associated with itching, flaking, pain and bleeding. Sotyktu is already approved in major markets to treat certain patients with moderate-to-severe plaque psoriasis after being shown in late-stage trials to improve skin clearance, symptom burden and quality of life. Alongside data from PSORIATYK SCALP, BMS also presented positive data from its Registry of Psoriasis Health Outcomes: A Longitudinal Real-World Collaboration Study (RePhlect) of 118 patients, 108 of whom had moderate-to-severe plaque psoriasis. The analysis found that the effectiveness of continuous Sotyktu treatment after six months in real-world registry patients was consistent with efficacy outcomes observed in the POETYK PSO clinical studies in patients with moderate-to-severe plaque psoriasis. Commenting on the latest results, Daniel Quirk, senior vice president, worldwide immunology and neuroscience medical affairs, BMS, said: “This data further demonstrates the safety and efficacy of Sotyktu for the treatment of psoriasis in high-impact areas, such as the scalp… We believe Sotyktu has the potential to be the systemic therapy that healthcare providers turn to when treating adult patients with moderate-to-severe psoriasis, especially those with scalp involvement.”

Campaign Encourages Open Dialogue With Doctor About Unmanaged Symptoms to Find the Right Treatment Option THOUSAND OAKS, Calif. , Oct. 1, 2024 /PRNewswire/ -- Amgen (NASDAQ: AMGN) has partnered with multi-talented actress, producer and entrepreneur La La Anthony to share her personal journey living with plaque psoriasis, and to inspire people to be open with their doctors about how the disease affects their daily lives. As one of the more than 6 million people in the United States living with plaque psoriasis, La La understands the frustrations of living with this disease. Symptoms can distract from everyday moments, big and small, even influencing clothing or makeup choices. 1,2 Experience the full interactive Multichannel News Release here: https://www2.multivu.com/amgen/9292951-en-la-la-anthony-amgen-partner-to-encourage-open-dialogue-about-plaque-psoriasis In a new interactive video , La La offers an intimate, behind-the-scenes look at how plaque psoriasis has affected her personal and professional life – and her realization of how important it is to advocate for treatment options that work well for her, and to help others do the same. "I have spent so much time and energy trying different methods to manage my plaque psoriasis that were often messy or inconvenient to apply, like a prescription shampoo for my scalp psoriasis. It required daily hair washing, which is not practical for my hair," said La La. "I was hesitant to tell my doctor that some treatments didn't work with my lifestyle, but I realized that doctors can only help if they know the full picture. I want to encourage people living with plaque psoriasis to be vocal about how the disease and treatments are impacting their daily lives." Although common, plaque psoriasis is a frequently misunderstood disease. Many people think it is a skin condition, but it is an autoimmune disease that starts as inflammation inside the body. 1 The inflammation presents as itchy, flaky patches that may cover large portions of the skin or only a few areas. 1 Research shows that people with plaque psoriasis and their doctors aren't always on the same page about how severe their condition is – with patients believing their symptoms to be more severe than their doctor's assessment. 3 Many people are prescribed topical treatments for plaque psoriasis patches, like creams or ointments. While these topical medications may provide relief, they are only treating the symptoms of the disease – not a root cause of inflammation – and are often viewed by patients as messy to apply. 4-7 "Plaque psoriasis is a chronic inflammatory condition and each patient's experience is unique," said board-certified dermatologist Meagen McCusker M.D ., M.S., FAAD. "The good news is advances in the field have given us a multitude of treatment options. For many patients who struggle with topical therapies, or who feel like their symptoms are not well managed by their current routine, I suggest talking to your doctor about a treatment option that helps reduce the underlying inflammation. Disease severity and lifestyle are key factors that influence a patient's choice for treatment – there is no one-size-fits all approach." To interact with La La in her new video, access resources to help facilitate an open conversation about plaque psoriasis treatment with your doctor and learn about Otezla ® (apremilast), an oral treatment option, visit MomentsWithLaLa.com . La La is not currently on treatment or taking Otezla. Amgen is committed to supporting plaque psoriasis patients to ensure that appropriate patients have affordable access to Otezla. For more information, please visit Otezla.com . About Psoriasis Psoriasis is a chronic disease where skin cells build up quickly, typically causing red or discolored, scaly, and itchy patches on the skin. 1 Approximately 125 million people worldwide have psoriasis, including more than 8 million people in the United States . 8,9 About 80% of those patients have plaque psoriasis. 2 About Otezla ® (apremilast) Otezla ® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined. Since its initial FDA approval in 2014, Otezla has been prescribed to more than 1 million patients worldwide. INDICATIONS Otezla ® (apremilast) is indicated for the treatment of: IMPORTANT SAFETY INFORMATION Contraindications Warnings and Precautions Adverse Reactions Use in Specific Populations Please click here for the full Prescribing Information for Otezla. About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions . Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average ® , and it is also part of the Nasdaq-100 Index ® , which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. For more information, visit Amgen.com and follow Amgen on X , LinkedIn , Instagram , TikTok , YouTube and Threads . Amgen Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. 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CONTACT: Amgen , Thousand Oaks Elissa Snook , 609-251-1407 (media) Breen Weir , 415-535-9814 (media) Justin Claeys , 805-313-9775 (investors) References ### View original content: https://www.prnewswire.com/news-releases/la-la-anthony-partners-with-amgen-to-share-candid-behind-the-scenes-look-at-how-plaque-psoriasis-affects-her-life-302263339.html SOURCE Amgen