Upadacitinib hemihydrate

Five Investigational New Drug (IND) applications cleared across a range of therapeutic areas and FDA divisions for lead asset, IMVT-1402Proof of concept data from batoclimab trial in Graves’ disease (GD) demonstrate potential of deeper IgG reduction with potent FcRn inhibition to transform treatment for GD patients who are not well controlled on antithyroid drugs (ATDs); initiation of potentially registrational trial to evaluate IMVT-1402 in GD expected by year endIND cleared for IMVT-1402 in rheumatoid arthritis (RA), with potential best-in-class profile in difficult-to-treat (D2T) RA; initiation of potentially registrational trial to evaluate IMVT-1402 in D2T RA expected by March 31, 2025On track to initiate potentially registrational trials with IMVT-1402 in four to five indications, inclusive of GD and D2T RA, by March 31, 2025Batoclimab trials in myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP) fully enrolled to support data disclosures by March 31, 2025; data from batoclimab trials in thyroid eye disease (TED) now expected in the second half of calendar year 2025; all batoclimab data will inform future trials with IMVT-1402Immunovant to host development update call today, November 7, at 8 a.m. ET NEW YORK, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported development updates and financial results for its fiscal second quarter ended September 30, 2024. Immunovant continues to focus on moving rapidly to unlock the full potential of its lead asset, IMVT-1402, for the benefit of people with underserved autoantibody-driven diseases. With five IND applications now cleared, the company remains on course to initiate four to five potentially registrational clinical development programs by March 31, 2025. These INDs are expected to support evaluation of IMVT-1402 in a variety of indications and therapeutic areas. As previously announced, Immunovant anticipates initiating clinical trials evaluating IMVT-1402 in a total of ten indications by March 31, 2026. “Since announcing the Phase 1 data for IMVT-1402 a year ago, we have made tremendous progress in advancing IMVT-1402 towards multiple potentially registrational study initiations. We’re ahead of our goal to activate three INDs by calendar year end and we are very excited about all five cleared INDs – both those that have been announced and those that have not yet been announced. In terms of announced indications, we believe our first-in-class program with IMVT-1402 in GD has the potential to transform the treatment of GD patients who respond poorly to ATDs,” said Pete Salzmann, M.D., chief executive officer of Immunovant. “We are also excited to announce expansion of our IMVT-1402 development program into Rheumatology. Our first program in Rheumatology will be a potentially registrational study in patients with D2T RA where we believe that deeper IgG reduction has the potential to deliver better clinical outcomes in an important subset of patients with elevated RA-specific autoantibodies (ACPA). People living with D2T RA have already exhausted multiple therapeutic options yet continue to suffer from active disease, persistent disability and pain,” Salzmann continued. “We believe IMVT-1402 can deliver meaningful clinical benefit in ACPA-positive (ACPA+) D2T RA patients, with a potentially best-in-class profile driven by deeper IgG reduction.” FcRn inhibition represents an attractive mechanism as a potential treatment for the approximately 70,000 US patients with D2T, ACPA+ RA. Recently disclosed in-class data demonstrated that both higher baseline ACPA levels and deeper ACPA reduction correlated with better clinical improvement in ACPA+ RA patients treated with an FcRn inhibitor. Having received FDA clearance of the IND for IMVT-1402 in RA, Immunovant plans to initiate a potentially registrational trial in ACPA+ D2T RA by March 31, 2025. The trial builds on in-class learning in terms of its target population (enriched for above-normal ACPA levels) and trial design (open-label lead-in followed by randomized withdrawal). The trial will leverage IMVT-1402’s higher dose (600 mg) during the open-label induction phase of the clinical trial to maximize reduction in ACPA levels. Recent Highlights and Upcoming Milestones Endocrinology Program In September 2024, Immunovant provided a GD program update consisting of new epidemiologic data characterizing unmet need in GD patients who are relapsed, uncontrolled or intolerant of ATDs, additional results from the batoclimab GD study, and an overview of the IMVT-1402 development program in GD. In November 2024, additional data on the efficacy and safety of batoclimab in Graves’ thyroidal and extrathyroidal disease were presented in an oral presentation at the American Thyroid Association (ATA) 2024 Annual Meeting. These data showed that a 60% response rate (defined as T3 and T4 falling below the upper limit of normal (ULN) without increasing the ATD dose) was achieved by Week 2, demonstrating the rapidity of response to batoclimab 680mg dosed weekly. Meaningful improvements in proptosis and lid aperture were also observed at both Week 12 and Week 24. Pronounced improvements in multiple Thyroid-Related Patient-Reported Outcomes (ThyPRO-39) measurement scales were also observed, with ATD-Free Responders (defined as T3 and T4 falling below the ULN and ceasing all ATD medications) reporting greater improvements than other participants. The batoclimab data in Graves’ disease support the potential for deep IgG reduction to modify the underlying pathophysiology of the disease, which could enable a transformation of the treatment of Graves’ disease for patients not well controlled on ATDs. Immunovant remains on track to initiate the first potentially registrational trial of IMVT-1402 in GD by calendar year end. Competition for clinical trial participants with acute, active TED has increased over the course of the company’s Phase 3 program to evaluate batoclimab for the treatment of thyroid eye disease (TED). As a result, top-line results are now expected to be available in the second half of calendar year 2025, along with a decision on whether to advance batoclimab to registration in TED. Data from this trial will be leveraged to inform the overall program in GD for the Company’s lead asset, IMVT-1402. Neurology Program As previously reported, Immunovant completed enrollment of the batoclimab pivotal trial in MG, with top-line results expected to be reported by March 31, 2025. Results from this trial are expected to inform a decision regarding next steps for batoclimab in MG and the design of the MG program for IMVT-1402, which Immunovant expects to initiate by March 31, 2025. Enrollment of study participants has completed in the Phase 2b trial evaluating batoclimab in chronic inflammatory demyelinating polyneuropathy (CIDP) for those patients to be included in the period 1 data readout expected by March 31, 2025. A decision to enroll additional patients in the batoclimab CIDP study will be made following the readout of period 1 data. Those results, as well as observations drawn from public disclosures of other studies in CIDP, will be used to inform the trial design for a potentially registrational program for IMVT-1402 in CIDP. Corporate Update Immunovant also announced today that it appointed Melanie Gloria as Chief Operating Officer, effective November 18, 2024. Ms. Gloria brings over 20 years of experience in the biotechnology industry, including leadership roles at Acelyrin, Horizon Therapeutics and AbbVie. At AbbVie and Horizon she led teams to achieve global approvals of HUMIRA®, Viekera Pak®, Mavyret®, Skyrizi®, Rinvoq®, TEPEZZA®, and ORILISSA®. “I am thrilled to welcome Melanie to Immunovant where her success in driving late-stage drug development will be incredibly valuable,” said Salzmann. “Melanie’s proven drug development capabilities are a great fit for Immunovant’s portfolio.” Webcast Details Immunovant will host a webcast at 8:00 a.m. ET today to discuss these updates. Please click register here to register for the event. The live webcast will also be available under the News & Events section of Immunovant’s website. A replay of the event and presentation will be available immediately following the event. Financial Highlights for Fiscal Second Quarter Ended September 30, 2024: Cash Position: As of September 30, 2024, Immunovant’s cash and cash equivalents totaled approximately $472.9 million. R&D Expenses: Research and development expenses were $97.3 million for the three months ended September 30, 2024, compared to $48.0 million for the three months ended September 30, 2023. The increase was primarily due to activities in preparation for potential future clinical trials of IMVT-1402, including contract manufacturing costs for drug substance, higher overall clinical trial costs related to our batoclimab pivotal clinical trials, and elevated personnel-related expenses. The increase was partially offset by lower overall costs related to our IMVT-1402 Phase 1 trial and nonclinical studies. G&A Expenses: General and administrative expenses were $18.5 million for the three months ended September 30, 2024, compared to $13.8 million for the three months ended September 30, 2023. The increase was primarily due to higher personnel-related expenses, legal and other professional fees, and information technology costs. Net Loss: Net loss was $109.1 million ($0.74 per common share) for the three months ended September 30, 2024, compared to $58.7 million ($0.45 per common share) for the three months ended September 30, 2023. Net loss for the three months ended September 30, 2024 and September 30, 2023 included $12.7 million and $10.5 million, respectively, related to non-cash stock-based compensation expense. Common Stock: As of September 30, 2024, there were 146,565,049 shares of common stock issued and outstanding. Financial Highlights for Fiscal Six Months Ended September 30, 2024: R&D Expenses: Research and development expenses were $172.7 million for the six months ended September 30, 2024, compared to $98.5 million for the six months ended September 30, 2023. The increase was primarily due to activities in preparation for potential future clinical trials of IMVT-1402, including contract manufacturing costs for drug substance, higher overall clinical trial costs related to our batoclimab pivotal clinical trials, and elevated personnel-related expenses. The increase was partially offset by lower overall costs related to our IMVT-1402 Phase 1 trial and nonclinical studies. IPR&D Expenses: There were no acquired in-process research and development expenses for the six months ended September 30, 2024. During the six months ended September 30, 2023, acquired in-process research and development expenses were $12.5 million related to the achievement of development and regulatory milestones for batoclimab under the terms of the HanAll in-license agreement. G&A Expenses: General and administrative expenses were $37.3 million for the six months ended September 30, 2024, compared to $29.2 million for the six months ended September 30, 2023. The increase was primarily due to higher personnel-related expenses, legal and other professional fees, and information technology costs. Net Loss: Net loss was $196.3 million ($1.34 per common share) for the six months ended September 30, 2024, compared to $132.6 million ($1.01 per common share) for the six months ended September 30, 2023. Net loss for the six months ended September 30, 2024 and September 30, 2023 included $26.1 million and $21.2 million, respectively, related to non-cash stock-based compensation expense. About Immunovant, Inc. Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit immunovant.com. Forward-Looking Statements This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “can,” “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” “design,” “plan,” “anticipate,” “intend,” and other similar expressions are intended to identify forward-looking statements. Such forward looking statements include statements regarding Immunovant’s expectations regarding the timing, design, and results of clinical trials of IMVT-1402 and batoclimab, including the number and timing of (a) FDA clearance with respect to IND applications, (b) potential registrational programs and clinical trials of IMVT-1402, (c) expected data readouts from batoclimab trials in MG and CIDP, and (d) estimates of the target populations for IMVT-1402, including in RA; Immunovant’s plan to develop IMVT-1402 and batoclimab across a broad range of indications; and potential benefits of IMVT-1402’s unique product attributes and potential best-in-class profile. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: Immunovant may not be able to protect or enforce its intellectual property rights; initial results or other preliminary analyses or results of early clinical trials may not be predictive of final trial results or of the results of later clinical trials; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant’s product candidates, including the number and timing of the commencement of additional clinical trials; Immunovant’s scientific approach, clinical trial design, indication selection, and general development progress; future clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this press release; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant’s product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the potential impact of macroeconomic and geopolitical factors on Immunovant’s business operations and supply chain, including its clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval, and commercialization of IMVT-1402 and/or batoclimab; Immunovant is at various stages of clinical development for IMVT-1402 and batoclimab; and Immunovant will require additional capital to fund its operations and advance IMVT-1402 and batoclimab through clinical development. These and other risks and uncertainties are more fully described in Immunovant’s periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled “Risk Factors” in Immunovant’s Form 10-Q to be filed with the SEC on November 7, 2024, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. IMMUNOVANT, INC.Consolidated Statements of Operations(Unaudited, in thousands, except share and per share data) Three Months EndedSeptember 30, Six Months EndedSeptember 30, 2024 2023 2024 2023 Operating expenses: Research and development$97,272 $47,959 $172,745 $98,534 Acquired in-process research and development — — — 12,500 General and administrative 18,471 13,841 37,279 29,243 Total operating expenses 115,743 61,800 210,024 140,277 Interest income (6,073) (3,572) (13,254) (7,637)Other income, net (629) (20) (657) (484)Loss before provision for income taxes (109,041) (58,208) (196,113) (132,156)Provision for income taxes 78 454 156 443 Net loss$(109,119) $(58,662) $(196,269) $(132,599)Net loss per common share – basic and diluted$(0.74) $(0.45) $(1.34) $(1.01)Weighted-average common shares outstanding – basic and diluted 146,468,991 131,155,642 146,313,696 130,872,717 IMMUNOVANT, INC.Consolidated Balance Sheets(Unaudited, in thousands, except share and per share data) September 30, 2024 March 31, 2024Assets Current assets: Cash and cash equivalents$472,941 $635,365 Accounts receivable 1,876 5,337 Prepaid expenses and other current assets 32,555 25,068 Total current assets 507,372 665,770 Operating lease right-of-use assets 45 133 Other assets 7,619 — Property and equipment, net 671 462 Total assets$515,707 $666,365 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable$20,727 $7,155 Accrued expenses 45,879 41,315 Current portion of operating lease liabilities 47 138 Total current liabilities 66,653 48,608 Total liabilities 66,653 48,608 Commitments and contingencies Stockholders’ equity: Series A preferred stock, par value $0.0001 per share, 10,000 shares authorized, issued and outstanding at September 30, 2024 and March 31, 2024 — — Preferred stock, par value $0.0001 per share, 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2024 and March 31, 2024 — — Common stock, par value $0.0001 per share, 500,000,000 shares authorized, 146,565,049 shares issued and outstanding at September 30, 2024 and 500,000,000 shares authorized, 145,582,999 shares issued and outstanding at March 31, 2024 14 14 Additional paid-in capital 1,469,082 1,441,518 Accumulated other comprehensive income 1,910 1,908 Accumulated deficit (1,021,952) (825,683)Total stockholders’ equity 449,054 617,757 Total liabilities and stockholders’ equity$515,707 $666,365 Contact:Renee Barnett, MBAChief Financial OfficerImmunovant, Inc.info@immunovant.com

Sixteen presentations of preclinical studies funded by the Lupus Research Alliance (LRA) to advance understanding of lupus and potential treatment pathways, including four oral presentations Two reports by Lupus Therapeutics, the clinical affiliate of the LRA, and the Lupus Clinical Investigators Network (LuCIN) on promoting equity in lupus clinical trials, and identifying trial barriers and solutions Fifteen industry-sponsored clinical research studies supported by Lupus Therapeutics and LuCIN, including positive results from the late-breaking Phase 3 dapirolizumab pegol trial NEW YORK, Nov. 4, 2024 /PRNewswire/ -- The Lupus Research Alliance (LRA), the largest private funder of lupus research worldwide, today announced that a total of 33 studies, funded by the organization or supported by its clinical research affiliate Lupus Therapeutics, will be presented at ACR Convergence 2024. The annual meeting of the American College of Rheumatology takes place November 14-19, at the Walter E. Washington Convention Center in Washington, D.C. The LRA, which seeks to accelerate the discovery and development of patient-centered treatments and diagnostics, pursues strategies to spur advancements from "bench to bedside." LRA-supported studies presented at ACR Convergence 2024 represent the full continuum of lupus research, from foundational research exploring new avenues of knowledge, to clinical trials evaluating potential new treatments. "ACR Convergence 2024 is met with pride and excitement by the Lupus Research Alliance and Lupus Therapeutics – pride in seeing the fruits of our funding and other initiatives to accelerate drug discovery and development, and excitement as we stand on the precipice of some important advancements," said LRA President and CEO Albert T. Roy. "There are more trials in mid-to-late-stage development than ever before, including dapirolizumab pegol in Phase 3 from UCB/Biogen, a Lupus Therapeutics partner. And we are gratified to witness the volume of CAR T cell therapy approaches in clinical development, having invested in 2014 in early research suggesting this approach as a promising intervention to explore for treating lupus," Roy added. Foundational Research Funded by the LRA Sixteen studies of LRA-funded research (four oral presentations and 12 posters) will be presented. Several focus on Childhood-Onset Systemic Lupus Erythematosus (cSLE), including: a detailed characterization of the disease; the effects of fatigue on pediatric patients' mental and physical health; and the discovery of Anti-Mitochondrial Antibodies (AMA), which are linked to higher disease activity. Other studies include: the development of a precision immunotherapy to target harmful B cells in Antiphospholipid Syndrome (APS) patients; the discovery of innate signaling pathways crucial in causing inflammation in lupus patients; and the epidemiology of strokes in children and adults with lupus. ORAL PRESENTATIONS Saturday, Nov. 16 Abstract #0837: Bispecific Autoantigen-T Cell Engagers (BaiTE) to Selectively Target Autoreactive B Cells in Antiphospholipid Syndrome 3:00-3:15 PM, Room 103AB Sunday, Nov. 17 Abstract #1702: Placental Developmental Defects in a Humanized-TLR8 Mouse Model of Spontaneous Anti-Phospholipid Antibody Induced Pregnancy Loss 3:15-3:30 PM , Room 103AB Monday, Nov. 18 Xist and XChromosome Inactivation in Female Biased Autoimmunity 9:00-9:30 AM, Room 145AB Abstract #2625: Brain Injury Markers Correlate with Impaired Executive Function and Disease Activity in Children with Systemic Lupus Erythematosus 3:30-3:45 PM, Room 202AB POSTERS Saturday, Nov. 16 Poster Session A, 10:30 AM-12:30 PM, Poster Hall: Abstract #0091: Targeting Endothelial Dysfunction in Lupus Nephritis: Effect of Sepiapterin, a Drug That Restores Endothelial Nitric Oxide Synthase Function, in a Murine Model of Lupus Nephritis Abstract #0098: Anti-HSP90α as a Protective Natural Antibody Against Secondary Antiphospholipid Syndrome in Systemic Lupus Erythematosus Sunday, Nov. 17 Poster Session B, 10:30 AM-12:30 PM , Poster Hall: Abstract #1266: Anti-Mitochondrial Antibodies Associate with Disease Activity and IFNα Expression in Childhood-onset Systemic Lupus Erythematosus Abstract #1273: An Investigation of Traumatic Events and Mental Health in cSLE Abstract #1274: Comparing Performance-Based Measures and Self-Reported Questionnaires for Assessment of Executive Function for Youth with Childhood-Onset Systemic Lupus Erythematosus Abstract #1278: The Effects of Fatigue on Self-Reported Mental and Physical Health in Childhood-Onset Systemic Lupus Erythematosus: A Cross-Sectional Study Abstract #1279: Cerebrovascular Accidents in Pediatric and Adult Systemic Lupus Erythematosus: A Comparison of Epidemiology and Outcomes Abstract #1280: Abnormal Cortical Gyrification Patterns in Adolescents with Childhood-onset SLE: Early Associations with Perceived Fatigue Abstract #1504: Novel Analytes Associated with Cognitive Impairment in Patients with Systemic Lupus Erythematosus: Serum S100A8/A9, MMP-9 and IL-6 Abstract #1506: Cognitive Impairment Prevalence and Most Affected Domains in Patients with SLE by the ACR Comprehensive Neuropsychological Battery Monday, Nov. 18 Poster Session C, 10:30 AM-12:30 PM, Poster Hall: Abstract #1788: Memory B Cell Activation and Dysregulation in Systemic Lupus Erythematosus Abstract #2380: Characterizing SLE Patients into Type 1 and Type 2 Disease States: Insights from a Single Lupus Cohort Research Conducted by Lupus Therapeutics and the Lupus Clinical Investigators Network (LuCIN) Lupus Therapeutics, the clinical affiliate of the Lupus Research Alliance, oversees the Lupus Clinical Investigators Network (LuCIN), consisting of 50+ premier, leading medical research institutions in North America, comprised of 200+ providers with expertise in lupus care and clinical trials. The following studies are based on annual surveys of LuCIN investigators and research teams on promoting equity in lupus clinical trials and identifying trial barriers and solutions. POSTERS Saturday, Nov. 16 Abstract 0180: Collaborative Solutions to Lupus Trial Challenges for Underrepresented Participant Recruitment & Engagement: Perspectives from the Lupus Clinical Investigators Network (LuCIN) Poster Session A, 10:30 AM-12:30 PM, Poster Hall Sunday, Nov. 17 Abstract #1039: Through the LuCIN Lens: Defining Barriers and Forging Solutions for Lupus Clinical Trials in North America Poster Session B, 10:30 AM-12:30 PM, Poster Hall Clinical Research Supported by Lupus Therapeutics and LuCIN The primary goal of Lupus Therapeutics and LuCIN is to accelerate and enhance the quality of lupus clinical trials through clinical expertise, advisory services, patient engagement and partnership/collaboration with biopharmaceutical companies and research partners. Lupus Therapeutics and LuCIN are involved in nearly 25% of active lupus clinical trials. Fifteen Lupus Therapeutics/LuCIN-supported programs and collaborations are being presented at ACR Convergence 2024: ORAL PRESENTATIONS Sunday, Nov. 17 Abstract #1773: Safety and Efficacy of CABA-201, a Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Patients with Immune-Mediated Necrotizing Myopathy and Systemic Lupus Erythematosus from the RESET-MyositisTM and RESET-SLETM Clinical Trials 3:30-3:45 PM, Room 145AB Monday, Nov. 18 Abstract #2577: Efficacy and Safety of ABBV-599 (Elsubrutinib and Upadacitinib Combination) and Upadacitinib Monotherapy for the Treatment of Systemic Lupus Erythematosus: Results Through 104 Weeks in a Long-Term Extension Study 1:30-1:45 PM, Room 146AB Abstract #2580: Safety and Efficacy of Subcutaneous Ianalumab (VAY736) for up to 68 Weeks in Patients with Systemic Lupus Erythematosus: Results from Phase 2 Study 2:15-2:30 PM Room 146AB Tuesday, Nov. 19 ***LATE-BREAKING ABSTRACT*** Abstract #L16: Dapirolizumab Pegol Demonstrated Significant Improvement in Systemic Lupus Erythematosus Disease Activity: Efficacy and Safety Results of a Phase 3 Trial 8:00-9:30 AM, 146AB POSTERS Saturday, Nov. 16 Poster Session A, 10:30 AM-12:30 PM, Poster Hall: Abstract #0087: SYNCAR: An Engineered IL-2/IL-2R-system That Selectively Enhances CD19 CAR T Cells to Deplete B Cells and Provide Therapeutic Benefit in SLE and RA Mouse Models Without Lymphodepletion Abstract #0324: Correlative Studies of CABA-201, a Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Patients with Immune-Mediated Necrotizing Myopathy and Systemic Lupus Erythematosus from the RESET-MyositisTM and RESET-SLETM Clinical Trials Abstract #0620: Clinical Efficacy and Patient-Reported Outcomes in Anti-Ro/Sjögren's Syndrome–Related Antigen a Antibody–Positive Patients with Active SLE Treated With Deucravacitinib in the Phase 2 PAISLEY Trial Abstract #0659: Obinutuzumab Benefits Patients with Active Lupus Nephritis Irrespective of Baseline Proteinuria Severity: A Post Hoc Analysis of a Phase II Trial Abstract #0662: Deucravacitinib, a First-in-Class, Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in SLE: Efficacy by Baseline Demographics and Disease Characteristics in the Phase 2 PAISLEY Trial Abstract #0671: Effect of Litifilimab on Cutaneous Lupus Disease Area and Severity Index–Activity (CLASI-A) Subcomponents and Physician Global Assessment–Skin (PGA–Skin) in Patients with Cutaneous Lupus Erythematosus (CLE) in a Phase 2 Study Sunday, Nov. 17 Poster Session B, 10:30 AM-12:30 PM, Poster Hall: Abstract #1496: Dysregulated Serum Cytokines in Association with Clinical Manifestations in Patients with Systemic Lupus Erythematosus Abstract #1552: Kinetics of Mucocutaneous and Musculoskeletal Responses to Deucravacitinib in Patients with Active SLE in the Phase 2 PAISLEY Trial Abstract #1553: Safety, Pharmacokinetics, Clinical Efficacy and Exploratory Biomarker Results from a Randomized, Double-Blind, Placebo-Controlled Phase 1b Study of Enpatoran in Active Systemic and Cutaneous Lupus Erythematosus (SLE/CLE) Monday, Nov. 18 Poster Session C, 10:30 AM-12:30 PM, Poster Hall: Abstract #2425: Ianalumab Induced Durable Depletion of Circulating B Cell Subsets and Associated Changes in B Cell and Neutrophil Transcriptomic and Proteomic Profiles in Patients with Systemic Lupus Erythematosus: 52-Week Treatment Results from a Phase 2 Trial Abstract #2430: Dapirolizumab Pegol Impacts Important Immunologic Pathways in Systemic Lupus Erythematosus: Pharmacodynamic Analysis of T Cell and Antigen Presenting Cell Pathways from a Phase 2b Trial About Lupus Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. In lupus, the immune system, meant to defend against infections, produces autoantibodies that mistake the body's own cells as foreign, causing other immune cells to attack organs such as the kidneys, brain, heart, lungs and skin, as well as blood and joints. Ninety percent of people with lupus are women, most often diagnosed between the ages of 15-45. Black, Latinx, Indigenous, Asian and Pacific Islander people are disproportionately affected by lupus and more likely to experience severe lupus symptoms. About the Lupus Research Alliance The Lupus Research Alliance is the largest non-governmental, non-profit funder of lupus research worldwide. The organization aims to transform treatment by funding the most innovative lupus research, fostering diverse scientific talent, and driving discovery toward better diagnostics, improved treatments and ultimately a cure for lupus. Because the Lupus Research Alliance's Board of Directors funds all administrative and fundraising costs, 100% of all donations goes to support lupus research programs. For more information, please visit the LRA at LupusResearch.org and on social media at: X, Facebook, LinkedIn, and Instagram. About Lupus Therapeutics Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance, aims to accelerate the development of curative treatments for all patients living with lupus. Lupus Therapeutics collaborates with premier research institutions, biopharmaceutical partners, and those living with lupus through the unprecedented Lupus Clinical Investigators Network (LuCIN) to drive rapid and meaningful progress in treatment development. The organization elevates the patient voice, engages community stakeholders, and strives for representation of the diverse lupus community in the clinical research process with the most innovative and renowned experts throughout North America. Visit LupusTherapeutics.org for more information. This information is brought to you by the Lupus Research Alliance and is not sponsored by, nor a part of, the American College of Rheumatology. SOURCE Lupus Research Alliance WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED