[Translation] A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of DAPIROLIZUMAB PEGOL in subjects with moderately to severely active SLE

评价使用DZP作为标准治疗药物的辅助治疗是否能够长期改善中重度疾病活动度的临床相关症状评价使用DZP作为标准治疗药物的辅助治疗是否能够快速改善中重度疾病活动度的临床相关症状评价使用DZP作为标准治疗药物的辅助治疗是否能够长期控制疾病活动度评价使用DZP作为标准治疗药物的辅助治疗是否能够实现和维持治疗达标目的：使用低/可接受剂量的皮质类固醇即可长期保持低疾病活动度评价使用DZP作为标准治疗药物的辅助治疗是否能够改善疾病活动度（通过临床实践中常用的疾病状态数值评分量表进行判定）评价使用DZP作为标准治疗药物的辅助治疗是否能够达到复合主要终点各组成部分的评分改善评价使用DZP作为标准治疗药物的辅助治疗是否能够达到替代终点应答评价使用DZP作为标准治疗药物的辅助治疗是否能够达到对其他关键次要终点提供支持的终点评价使用DZP作为标准治疗药物的辅助治疗的安全性和耐受性

[Translation]

To evaluate whether DZP as adjunctive treatment to standard treatment can improve clinically relevant symptoms of moderate to severe disease activity in the long term To evaluate whether DZP as adjunctive treatment to standard treatment can quickly improve clinically relevant symptoms of moderate to severe disease activity To evaluate whether DZP as adjunctive treatment to standard treatment can control disease activity in the long term To evaluate whether DZP as adjunctive treatment to standard treatment can achieve and maintain treatment goals: low disease activity can be maintained for a long time using low/acceptable doses of corticosteroids To evaluate whether DZP as adjunctive treatment to standard treatment can improve disease activity (determined by a numerical disease status rating scale commonly used in clinical practice) To evaluate whether DZP as adjunctive treatment to standard treatment can achieve improvements in the scores of each component of the composite primary endpoint To evaluate whether DZP as adjunctive treatment to standard treatment can achieve surrogate endpoint responses To evaluate whether DZP as adjunctive treatment to standard treatment can achieve endpoints that support other key secondary endpoints To evaluate the safety and tolerability of DZP as adjunctive treatment to standard treatment

Start Date04 Dec 2024

Sponsor / Collaborator

UCB Trading (Shanghai) Co., Ltd.

NCT06617325 / RecruitingPhase 3

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.

Start Date21 Nov 2024

Sponsor / Collaborator

UCB Biopharma SRL

NCT04976322 / Enrolling by invitationPhase 3

A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus

The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.

Start Date27 Jul 2021

Sponsor / Collaborator

UCB Biopharma SRL

100 Clinical Results associated with Dapirolizumab pegol

100 Translational Medicine associated with Dapirolizumab pegol

100 Patents (Medical) associated with Dapirolizumab pegol

577

Literatures (Medical) associated with Dapirolizumab pegol

01 Mar 2025·BEHAVIOURAL BRAIN RESEARCH

Anxiogenic-like effects of coumarin, possibly through the GABAkine interaction pathway: Animal studies with in silico approaches

Article

Author: Coutinho, Henrique D M ; Emon, Md ; Bappi, Mehedi Hasan ; Ansari, Siddique Akber ; Ripu, Tawfik Rakaiyat ; Ahmmed, Md Shakil ; Islam, Muhammad Torequl ; Prottay, Abdullah Al Shamsh ; Sarwar, Md Nazim ; Emamuzzaman ; Rahman, Towfiqur

BACKGROUND:

Anxiety disorder is the most common mental illness and a major contributor to impairment. Thus, there is an urgent need to find novel lead compounds to mitigate anxiety. It is widely recognized that the neurobiology of anxiety-related behavior involves GABAergic systems.

OBJECTIVES:

This research aimed to examine the anxiogenic action of coumarin (CMN), a natural benzopyrone derived from plants, and determine its underlying mechanism through in vivo and in silico investigations.

METHODS:

This was accomplished by using a variety of behavioral procedures, including open field, swing, hole cross, and light-dark tests, on male and female Swiss albino mice that had been orally administered three experimental doses of CMN (1, 2, and 4mg/kg). The CMN group was also examined with the GABA_A receptor agonist diazepam (DZP-2 mg/kg) and flumazenil antagonist (FLU-0.1mg/kg). Furthermore, CMN and standards were subjected to a molecular docking analysis to determine their binding affinities for the GABA_A receptor subunits (α1, α4, β2, γ2, and δ). Several software programs were used to visualize the ligand-receptor interaction and analyze the pharmacokinetic profile.

RESULTS:

Compared to typical treatments, our results show that CMN (1mg/kg) significantly (p<0.05) increases the locomotor activity of animals. Furthermore, CMN exerted the highest binding affinity (-6.5kcal/mol) with the GABA-α1 receptor compared to conventional DZP. Along with FLU, CMN displayed several hydrophobic and hydrogen bonds with GABA_A receptor subunits. The pharmacokinetic and drug-like properties of CMN are also remarkable. In animal studies, CMN worked synergistically with FLU to provide anxiogenic-like effects.

CONCLUSION:

We conclude that, based on in vivo and in silico data, CMN, alone or in combination with FLU, may be employed in future neurological clinical studies. However, further research is needed to confirm this behavioral activity and elucidate the possible mechanism of action.

01 Feb 2025·BEHAVIOURAL BRAIN RESEARCH

Anxiolytic-like effects of Prolistarina: A bioinspired peptide from the venom of social wasps

Article

Author: Ferreira, Jéssica W ; Mortari, Márcia R ; Monferrari-Martins, Beatriz ; Maior, Rafael S ; Campos, Gabriel A A ; Avon, Ísis

Pathological anxiety is among the most common psychiatric disorders. Despite advancements, predominant pharmacological treatments can lead to physical, chemical, and psychological dependence. Venoms of arthropods are important sources of neuroactive peptides with potential therapeutic applications for the treatment of neurological disorders. In this context, the anxiolytic effects of Prolistarina (PLT), a bioinspired peptide extracted from the venom of the social wasp Synoeca surinama, were evaluated in mice at the Elevated Plus Maze and Open Field tests. Intracerebroventricular infusions of PLT (6 and 2 nmol) were compared to diazepam (DZP; 2 mg/kg, ip) and pentylenetetrazole (PTZ; 30 mg/kg, ip). Both doses of PLT induced an increase in time spent in the open arms, although 6 nmol was significantly lower than DZP. Locomotor activity was not affected by PLT compared to vehicle, but a significant difference between 2 and 6 nmol was observed. Radioligand binding assays with PLT revealed no affinity for diazepam, naloxone or GABA binding sites. These preliminary results indicate an anxiolytic profile of PLT, but furthers studies are warranted to determine the mechanisms thereof.

01 Feb 2025·SLEEP MEDICINE

Assessment of sedative activity of Chrysin: Behavioral approach with pharmacokinetics, toxicological profile and molecular docking

Article

Author: Kamli, Hossam ; Islam, Muhammad Torequl ; Al Hasan, Md Sakib ; Bhuia, Md Shimul ; Saim, Md Abu ; Ahammed, Nowreen Tabassum ; Sheikh, Salehin ; Ansari, Siddique Akber ; Bithi, Sumaya Akter

The purpose of this study was to investigate the sedative effects of Chrysin (CHR) along with modulatory effects on diazepam (DZP) and flumazenil (FLU) in an animal sleep model produced by thiopental sodium (TS). Additionally, we explored the pharmacokinetics and potential GABA_A receptor interactions of CHR through computational studies. Swiss albino mice were treated with intraperitoneal administration of CHR (5 and 10 mg/kg), DZP (2 mg/kg), and FLU (0.1 mg/kg) either alone or in combination. Sleeping onset and duration were measured following TS administration. Molecular docking was performed to investigate CHR's binding affinity with GABA_A (PDB: 6X3X) receptors. Results found that CHR significantly (p < 0.05) reduced sleep latency and increased sleep duration in a dose-dependent manner compared to the control group. The highest dose (CHR-10) exhibited the most potent significant sedative effect with onset (11.57 ± 1.74 min) and duration (172.86 ± 7.37 min). Combination therapy of CHR-10 with DZP resulted in synergistic effects, further enhancing sleep duration. In molecular docking, CHR demonstrated a higher binding affinity (-8.9 kcal/mol) for GABA_A receptors compared to DZP (-8.7 kcal/mol) and FLU (-6.6 kcal/mol). CHR also showed favorable pharmacokinetic properties with high intestinal absorption and low toxicity. CHR exhibits promising sedative activity, with the potential to enhance the effects of traditional sedatives like DZP. However, further research, including clinical trials and detailed mechanistic studies, is warranted to explore its full therapeutic potential.

News (Medical) associated with Dapirolizumab pegol

19 Nov 2024

·www.prnewswire.com

Systemic Lupus Erythematosus Clinical Trial Pipeline Gains Momentum as 120+ Key Companies at the Forefront | DelveInsight

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease characterized by inflammation and tissue damage across multiple organ systems, such as the skin, joints, kidneys, heart, and brain. The incidence of autoimmune diseases, including SLE, has been increasing globally, with a significant impact on demand for targeted and effective therapies. LAS VEGAS, Nov. 19, 2024 /PRNewswire/ -- DelveInsight's ' Systemic Lupus Erythematosus Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline systemic lupus erythematosus therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the systemic lupus erythematosus pipeline domain. Key Takeaways from the Systemic Lupus Erythematosus Pipeline Report DelveInsight's systemic lupus erythematosus pipeline report depicts a robust space with 120+ active players working to develop 140+ pipeline therapies for systemic lupus erythematosus treatment. Key systemic lupus erythematosus companies such as Roche, ImmuPharma, UCB, Idorsia Pharmaceuticals, Biogen, AbbVie, Bristol-Myers Squibb, Vera Therapeutics, Beijing Mabworks Biotech Co., Ltd., BeiGene, Jiangsu Renocell Biotech Company, AstraZeneca, Pfizer, Red de Terapia Celular, Kira Pharmacenticals (US), LLC., Jemincare, Galapagos NV, Alumis, argenx, Gilead Sciences, Novartis, Zenas Biopharma, Horizon Therapeutics, Provention Bio, Janssen Research & Development, Eli Lilly and Company, Medsenic, Sanofi, Merck KGaA, Resolve Therapeutics, ILTOO, Janssen, Alpine Immune Sciences, Kezar Life Sciences, Neovacs, Kangpu Biopharmaceuticals, Cartesian Therapeutics, Apellis Pharmaceuticals, Inc., Alexion Pharmaceuticals, Inc., Q32 Bio Inc., Conduit Pharmaceuticals, Miltenyi Biomedicine GmbH, Kyverna Therapeutics, ImmPACT Bio, Genrix (Shanghai) Biopharmaceutical Co., Ltd., Gracell Biotechnologies (Shanghai) Co., Ltd., Cabaletta Bio, Tenet Medicines, Ascentage Pharma Group Inc., InnoCare, Eisai, Sorrento Therapeutics, Carna Bioscience, Yake Biotechnology, Equillium, Daiichi Sankyo Company, SinoMab Bioscience Ltd, Citryll BV, Sareum, Shanghai Junshi Biosciences, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Millennium Pharmaceuticals, Inc., Takeda, Synthekine, Hangzhou Sumgen Biotech Co., Ltd., Sana Biotechnology, Hoffmann-La Roche, Guangdong Ruishun Biotech Co., Ltd, Shanghai Ming Ju Biotechnology Co., Ltd., Autolus Limited, Nkarta, Inc., Luminary Therapeutics, Kyowa Kirin Co., Ltd., Shanghai Ming Ju Biotechnology, IGM Biosciences, Inc., GlaxoSmithKline, Fate Therapeutics, Cugene Inc., Century Therapeutics, Inc., Cullinan Therapeutics Inc., Juno Therapeutics, Inc., EdiGene Inc., Atara Biotherapeutics, Annexon, Inc., Adicet Therapeutics, Bioray Laboratories, PersonGen BioTherapeutics (Suzhou) Co., Ltd., Juventas Cell Therapy Ltd., Nanjing Bioheng Biotech Co., Ltd., Pregene ShenZhen Biotechnology, Artiva Bio, KeyMed Biosciences, IASO, JW Therapeutics, ROME Therapeutics, Ventus Therapeutics, Allosite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, LongBio Pharma, Amytrx Therapeutics, Corestem, Eliem Therapeutics, SinoMab Bioscience Ltd., and others are evaluating new systemic lupus erythematosus drugs to improve the treatment landscape. Promising systemic lupus erythematosus pipeline therapies such as Obinutuzumab, Lupuzor (IPP-201101), Dapirolizumab pegol, Cenerimod, BIIB059, Upadacitinib, Deucravacitinib, Atacicept, MIL62, Zanubrutinib, RY_SW01 cell injection|Basic treatment, Ravulizumab, Rapcabtagene autoleucel, PF-06823859, Mesenchymal stem cells (MSC), KP104, JMKX000189, Iptacopan, GLPG3667, ESK-001, Elsubrutinib, Efgartigimod alfa, Edecesertib, Ianalumab, Obexelimab (XmAb5871), Daxdilimab (VIB7734), PRV-3279, Nipocalimab, ABBV 599, NKTR-358 (LY3471851), Arscimed, SAR441344, Enpatoran, RSLV-132, Aldesleukin, Daratumumab, Branebrutinib, BMS-986256, ALPN-101, KZR-616, IFNα kinoid, KPG 818, Descartes-08, CFZ533, APL-2, ALXN2050, ADX-097, AZD1656, MB-CART19.1, KYV-101, IMPT-514, GR1603, GC012F Injection, CABA-201, Budoprutug, APG-2575, ICP-022, E6742, ALPN-303, AC0058, Mosunetuzumab, AS-0871, CD19/BCMA CAR T-cells, PF-06835375, EQ001 (Itolizumab), DS-7011a, SM03, CIT-013, SDC-1801, UBP1213, TQB3702, TAK-079, TAK-007, SYNCAR-001, SG301, SC291, RO7507062, RJMty19 (CD19-CAR-DNT cells), Relma-cel, PIT565, Obecabtagene autoleucel (obe-cel), NKX019, LMY-920, KK4277, JWCAR201, Imvotamab, GSK4527363, GSK4347859, FT819, CUG252, CNTY-101, CLN-978, CC-97540, Belantamab, ATHENA CAR-T ATA3219, ANX009, ADI-001, BRL-301, T-cell injection targeting CD19 chimeric antigen receptor, CNCT19, RD06-04, PRG-2311, PRG-1801, AlloNK, CM313, CT103A, JWCAR 029, Research program: endogenous reverse transcriptase inhibitors, VENT 03, ONT01, BCMA-CD19 cCAR T cells, CB-010, LP-005, AMTX 100, CE211AT15, TN-119, SN1011, QX002N, RSLV-145, Recombinant human plasma gelsolin, LN-008, TST 008, IBL 100s, and others are under different phases of systemic lupus erythematosus clinical trials. In October 2024, the FDA approved the investigational new drug (IND) application for Cullinan Therapeutics' CLN-978 to treat systemic lupus erythematosus (SLE). In September 2024, Cartesian Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of juvenile dermatomyositis (JDM). In September 2024, Caribou Biosciences announced that the U.S. Food and Drug Administration (FDA) had granted fast-track designation to CAR T-cell therapy CB-010 for systemic lupus erythematosus (SLE). In September 2024, UCB and Biogen reported successful results from their Phase III clinical trial of the PHOENYCS GO study, which tested dapirolizumab pegol as a treatment for moderate-to-severe systemic lupus erythematosus. In August 2024, Conduit Pharmaceuticals announced they will be conducting a Phase IIa clinical trial to evaluate AZD1656 for the treatment of multiple autoimmune diseases, including systemic lupus erythematosus (SLE). In July 2024, the first individual received the therapy Descartes-08 to treat systemic lupus erythematosus. This therapy has been previously administered to patients with myasthenia gravis, a long-term autoimmune disorder characterized by muscle weakness. In February 2024, Idorsia Pharmaceuticals formed a major global research and development partnership with Viatris to advance and commercialize two Phase III assets, selatogrel and cenerimod, on a global scale. Request a sample and discover the recent advances in systemic lupus erythematosus treatment drugs @ Systemic Lupus Erythematosus Pipeline Report The systemic lupus erythematosus pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage systemic lupus erythematosus drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the systemic lupus erythematosus clinical trial landscape. Systemic Lupus Erythematosus Overview Systemic lupus erythematosus (SLE) is a chronic autoimmune disease in which the immune system mistakenly attacks healthy tissues in various parts of the body. The exact cause of SLE is unknown, but it is believed to result from a combination of genetic, environmental, and hormonal factors. Common triggers include infections, sunlight exposure, and certain medications. Women, particularly of childbearing age, are more commonly affected. Symptoms of SLE vary widely and can affect many organ systems, leading to a wide range of clinical presentations. Common symptoms include fatigue, joint pain, skin rashes, photosensitivity, and fever. More severe cases can affect the kidneys, heart, lungs, and central nervous system, potentially leading to life-threatening complications. Diagnosis of SLE is based on a combination of clinical features and laboratory tests. The antinuclear antibody (ANA) test is a common initial screening tool, but additional tests like anti-double stranded DNA (anti-dsDNA) and anti-Smith antibodies, as well as assessments of kidney and liver function, are often necessary. Diagnosis can be challenging because SLE symptoms often mimic those of other diseases. Treatment for SLE focuses on managing symptoms and preventing flares. Mild cases may be treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and antimalarial drugs like hydroxychloroquine. More severe cases may require corticosteroids, immunosuppressive drugs such as azathioprine, methotrexate, or newer biologics like belimumab. Lifestyle modifications, such as avoiding excessive sun exposure and managing stress, are also essential in controlling the disease. Find out more about systemic lupus erythematosus treatment drugs @ Drugs for Systemic Lupus Erythematosus Treatment A snapshot of the Systemic Lupus Erythematosus Pipeline Drugs mentioned in the report: Learn more about the emerging systemic lupus erythematosus pipeline therapies @ Systemic Lupus Erythematosus Clinical Trials Systemic Lupus Erythematosus Therapeutics Assessment The systemic lupus erythematosus pipeline report proffers an integral view of the systemic lupus erythematosus emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Systemic Lupus Erythematosus Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Antibody-dependent cell cytotoxicity, Cell death inhibitors, Cell death stimulants, Immunomodulators, CD40 ligand inhibitors, Sphingosine 1 phosphate receptor modulators, Calcineurin inhibitors, Immunosuppressants, Janus kinase 1 inhibitors, TYK2 kinase inhibitors, B cell activating factor inhibitors, Tumour necrosis factor ligand superfamily member 13 inhibitors Key Systemic Lupus Erythematosus Companies: Roche, ImmuPharma, UCB, Idorsia Pharmaceuticals, Biogen, AbbVie, Bristol-Myers Squibb, Vera Therapeutics, Beijing Mabworks Biotech Co., Ltd., BeiGene, Jiangsu Renocell Biotech Company, AstraZeneca, Pfizer, Red de Terapia Celular, Kira Pharmacenticals (US), LLC., Jemincare, Galapagos NV, Alumis, argenx, Gilead Sciences, Novartis, Zenas Biopharma, Horizon Therapeutics, Provention Bio, Janssen Research & Development, Eli Lilly and Company, Medsenic, Sanofi, Merck KGaA, Resolve Therapeutics, ILTOO, Janssen, Alpine Immune Sciences, Kezar Life Sciences, Neovacs, Kangpu Biopharmaceuticals, Cartesian Therapeutics, Apellis Pharmaceuticals, Inc., Alexion Pharmaceuticals, Inc., Q32 Bio Inc., Conduit Pharmaceuticals, Miltenyi Biomedicine GmbH, Kyverna Therapeutics, ImmPACT Bio, Genrix (Shanghai) Biopharmaceutical Co., Ltd., Gracell Biotechnologies (Shanghai) Co., Ltd., Cabaletta Bio, Tenet Medicines, Ascentage Pharma Group Inc., InnoCare, Eisai, Sorrento Therapeutics, Carna Bioscience, Yake Biotechnology, Equillium, Daiichi Sankyo Company, SinoMab Bioscience Ltd, Citryll BV, Sareum, Shanghai Junshi Biosciences, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Millennium Pharmaceuticals, Inc., Takeda, Synthekine, Hangzhou Sumgen Biotech Co., Ltd., Sana Biotechnology, Hoffmann-La Roche, Guangdong Ruishun Biotech Co., Ltd, Shanghai Ming Ju Biotechnology Co., Ltd., Autolus Limited, Nkarta, Inc., Luminary Therapeutics, Kyowa Kirin Co., Ltd., Shanghai Ming Ju Biotechnology, IGM Biosciences, Inc., GlaxoSmithKline, Fate Therapeutics, Cugene Inc., Century Therapeutics, Inc., Cullinan Therapeutics Inc., Juno Therapeutics, Inc., EdiGene Inc., Atara Biotherapeutics, Annexon, Inc., Adicet Therapeutics, Bioray Laboratories, PersonGen BioTherapeutics (Suzhou) Co., Ltd., Juventas Cell Therapy Ltd., Nanjing Bioheng Biotech Co., Ltd., Pregene ShenZhen Biotechnology, Artiva Bio, KeyMed Biosciences, IASO, JW Therapeutics, ROME Therapeutics, Ventus Therapeutics, Allosite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, LongBio Pharma, Amytrx Therapeutics, Corestem, Eliem Therapeutics, SinoMab Bioscience Ltd., and others. Key Systemic Lupus Erythematosus Pipeline Therapies: Obinutuzumab, Lupuzor (IPP-201101), Dapirolizumab pegol, Cenerimod, BIIB059, Upadacitinib, Deucravacitinib, Atacicept, MIL62, Zanubrutinib, RY_SW01 cell injection|Basic treatment, Ravulizumab, Rapcabtagene autoleucel, PF-06823859, Mesenchymal stem cells (MSC), KP104, JMKX000189, Iptacopan, GLPG3667|Placebo, ESK-001, Elsubrutinib, Efgartigimod alfa, Edecesertib, Ianalumab, Obexelimab (XmAb5871), Daxdilimab (VIB7734), PRV-3279, Nipocalimab, ABBV 599, NKTR-358 (LY3471851), Arscimed, SAR441344, Enpatoran, RSLV-132, Aldesleukin, Daratumumab, Branebrutinib, BMS-986256, ALPN-101, KZR-616, IFNα kinoid, KPG 818, Descartes-08, CFZ533, APL-2, ALXN2050, ADX-097, AZD1656, MB-CART19.1, KYV-101, IMPT-514, GR1603, GC012F Injection, CABA-201, Budoprutug, APG-2575, ICP-022, E6742, ALPN-303, AC0058, Mosunetuzumab, AS-0871, CD19/BCMA CAR T-cells, PF-06835375, EQ001 (Itolizumab), DS-7011a, SM03, CIT-013, SDC-1801, UBP1213, TQB3702, TAK-079, TAK-007, SYNCAR-001, SG301, SC291, RO7507062, RJMty19 (CD19-CAR-DNT cells), Relma-cel, PIT565, Obecabtagene autoleucel (obe-cel), NKX019, LMY-920, KK4277, JWCAR201, Imvotamab, GSK4527363, GSK4347859, FT819, CUG252, CNTY-101, CLN-978, CC-97540, Belantamab, ATHENA CAR-T ATA3219, ANX009, ADI-001, BRL-301, T-cell injection targeting CD19 chimeric antigen receptor, CNCT19, RD06-04, PRG-2311, PRG-1801, AlloNK, CM313, CT103A, JWCAR 029, Research program: endogenous reverse transcriptase inhibitors, VENT 03, ONT01, BCMA-CD19 cCAR T cells, CB-010, LP-005, AMTX 100, CE211AT15, TN-119, SN1011, QX002N, RSLV-145, Recombinant human plasma gelsolin, LN-008, TST 008, IBL 100s, and others. Dive deep into rich insights for new drugs for systemic lupus erythematosus treatment, visit @ Systemic Lupus Erythematosus Drugs Table of Contents For further information on the systemic lupus erythematosus pipeline therapeutics, reach out @ Systemic Lupus Erythematosus Treatment Drugs Related Reports Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key SLE companies including Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie, among others. Systemic Lupus Erythematosus Epidemiology Systemic Lupus Erythematosus Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted SLE epidemiology in the 7MM. Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key lupus nephritis companies, including NOVARTIS, MORPHOSYS, ASTRAZENECA, ROCHE, KEZAR LIFE SCIENCES, ALEXION PHARMACEUTICALS, NOVARTIS, CABALETTA BIO, among others. Lupus Nephritis Pipeline Lupus Nephritis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including Inflection Biosciences, Equillium, Roche, Horizon Therapeutics, BeiGene, Janssen Research & Development, ImmPACT Bio, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Phase 2Fast TrackCell Therapy

19 Nov 2024

·pipelinereview.com

Dapirolizumab Pegol Phase 3 Data Presented at the American College of Rheumatology Shows Significant Reduction in Systemic Lupus Erythematosus Disease Activity

BRUSSELS, Belgium and CAMBRIDGE, MA, USA I November 19, 2024 I UCB (Euronext Brussels: UCB) and Biogen Inc. (NASDAQ: BIIB) today presented detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate, demonstrating significant clinical improvement in disease activity in people living with moderate-to-severe systemic lupus erythematosus (SLE). The results were shared during an oral, late-breaker presentation at ACR Convergence 2024, the American College of Rheumatology’s annual meeting, in Washington, DC. “There remains a significant unmet need for additional treatment options for people living with systemic lupus erythematosus and the results we observed in PHOENYCS GO suggest dapirolizumab pegol has the potential to be impactful for this chronic and debilitating autoimmune disease. Across clinical endpoints we observed a positive effect and a favorable safety profile,” said Megan E.B. Clowse, M.D., principal investigator of the study and Associate Professor of Medicine, Chief of the Division of Rheumatology and Immunology at Duke University School of Medicine. “Participants receiving dapirolizumab pegol experienced reduced lupus activity while also tapering steroids, changes important to people living with the disease.” In the PHOENYCS GO study (n=321), dapirolizumab pegol (DZP) was administered intravenously every four weeks. On the primary endpoint measuring improvement of moderate-to-severe disease activity as assessed by achievement of British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) after 48 weeks, study participants receiving DZP plus SOC had a statistically significant 14.6% (95% confidence interval [CI]: 3.3, 25.8; p=0.0110) higher response rate (49.5%) than those receiving SOC alone (34.6%). A higher BICLA response rate reflects a treatment response across all affected organs at baseline and is associated with meaningful clinical benefit. On the first secondary endpoint of BICLA response at Week 24, study participants receiving DZP plus SOC had a 7.9% higher response rate (46.6%) than those receiving SOC alone (38.3%). However, the difference did not reach statistical significance (95% CI: -3.6, 19.4; p=0.1776). Given statistical significance was not achieved for the first key secondary endpoint in the hierarchical testing, analyses for all the subsequent secondary endpoints are descriptive and nominal p-values are included. Subsequent analyses of additional secondary endpoints showed clinical improvements in the DZP group, including SLE Responder Index (SRI)-4 response, corticosteroid tapering, SLE Disease Activity Index-2K (SLEDAI-2K), achievement of Lupus Low Disease Activity State (LLDAS) and prevention of severe BILAG flares: “Due to the varied symptoms and severity by patient, progress in the treatment of lupus has historically been challenging. With dapirolizumab pegol, we believe that our differentiated approach that targets the CD40L pathway results in clinically meaningful improvements across multiple disease domains and could substantially impact the burden of this disease in particular for women, who are disproportionately affected by lupus,” said Fiona du Monceau, Head of Patient Evidence at UCB. “We are highly encouraged by the results we have seen in PHOENYCS GO and are excited to continue the clinical development of dapirolizumab pegol in the second Phase 3 study, PHOENYCS FLY.” The safety profile of dapirolizumab pegol was generally favorable. The safety results were consistent with previous DZP studies and with that in study participants with SLE receiving an immunomodulator. In the PHOENYCS GO study, a higher proportion of patients receiving DZP plus SOC had treatment-emergent adverse events (TEAEs) compared to SOC alone (82.6% vs. 75.0%). The proportion of participants with serious TEAEs was 9.9% in those participants receiving DZP plus SOC compared to 14.8% in those receiving SOC alone. Opportunistic infections were reported in 2.8% of participants receiving DZP plus SOC compared to 0.9% of those receiving SOC alone. Discontinuation of treatment or study participation due to TEAEs occurred in 4.7% (10) of participants receiving DZP plus SOC and 3.7% (4) of participants receiving SOC alone. “At Biogen, we understand that lupus affects everyone differently and are committed to developing treatments as diverse as the patients we serve,” said Diana Gallagher, MD, Head of AD, MS and Immunology Development Units at Biogen. “These results reinforce our belief that dapirolizumab pegol has the potential to change the approach to care of SLE and we are dedicated to advancing this program with our partner UCB.” Participants from the PHOENYCS GO study will continue to be followed in a long-term open-label study. In 2024, UCB and Biogen will initiate a second Phase 3 trial of dapirolizumab pegol, PHOENYCS FLY ( NCT06617325 ). The safety and efficacy of dapirolizumab pegol in systemic lupus erythematosus have not been established, and it is not approved for use in systemic lupus erythematosus by any regulatory authority worldwide. About Systemic Lupus Erythematosus (SLE) SLE is a chronic, multifactorial autoimmune disease that is caused by the activation of autoreactive T, B and antigen-presenting cells, resulting in manifestations across multiple organ systems with periods of illness or flares alternating with periods of inactivity. 1 SLE can present itself in several ways including rash, arthritis, anemia, thrombocytopenia, serositis, nephritis, seizures or psychosis. 2 SLE is associated with a greater risk of death from causes such as infection and cardiovascular disease. An estimated 90% of people living with lupus are women; most begin to see symptoms between the ages of 15-55. 3,4,5 Individuals from populations of African, Hispanic, Asian and Native American descent are at a greater risk of earlier onset and more aggressive disease. 6,7 Pregnancy in women with SLE is high risk, with higher maternal and fetal mortality and morbidity than the general population. 8,9 About Dapirolizumab Pegol Dapirolizumab pegol is a novel investigational humanized Fc-free polyethylene glycol (PEG)-conjugated antigen-binding (Fab’) fragment. Dapirolizumab pegol inhibits CD40L signaling which has been shown to reduce B cell activation and autoantibody production, mitigate type 1 interferon (IFN) secretion, and attenuate T cell and antigen-presenting cell (APC) activation. 10 Dapirolizumab pegol is presently in Phase 3 clinical development for the treatment of systemic lupus erythematosus (SLE) under a collaboration between UCB and Biogen. 11 About UCB UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. UCB is listed on Euronext Brussels (symbol: UCB). About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. The company routinely posts information that may be important to investors on its website at www.biogen.com . Follow us on social media – Facebook , LinkedIn , X , YouTube . References: SOURCE: UCB

Phase 3Clinical Result

19 Nov 2024

·www.prnewswire.com

Lupus Therapeutics Statement on Phase 3 PHOENYCS GO Positive Data in Moderate-To-Severe Systemic Lupus

WASHINGTON, Nov. 19, 2024 /PRNewswire/ -- Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance (LRA), is encouraged by the positive Phase 3 PHOENYCS GO data reported by UCB and Biogen during ACR Convergence 2024. Study sponsors provided a detailed analysis of the pivotal trial to evaluate the efficacy and safety of dapirolizumab pegol (DZP) in patients with moderate-to-severe systemic lupus erythematosus (SLE). Per the study sponsors: "DZP met its primary endpoint, demonstrating statistically and clinically significant improvement across all organ systems as measured by BICLA, an endpoint measuring disease activity. A greater response was observed across multiple clinical endpoints among participants treated with DZP, including 50% less severe disease flares compared to participants on standard of care alone." Following is a statement by Lupus Therapeutics Executive Vice President Stacie Bell, PhD: The Phase 3 PHOENYCS GO trial demonstrated significant improvement in SLE disease activity, making dapirolizumab pegol a promising candidate for treating moderate-to-severe SLE. By inhibiting the CD40 ligand, which plays a crucial role in the immune system response, dapirolizumab pegol offers a novel way to address multiple aspects of the underlying mechanisms of lupus and distinguishes the approach from currently available treatments. Lupus Therapeutics is proud to have partnered with UCB and Biogen on this study, leveraging the organizational clinical expertise and LuCIN clinical site support. Most of all, Lupus Therapeutics is pleased that these promising outcomes may lead to another treatment option for those living with SLE. Based on this trial, UCB and Biogen is initiating a second Phase 3 trial of dapirolizumab pegol, PHOENYCS FLY, in 2024. For more information, read the UCB-Biogen press release. 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

Phase 3Clinical Result

100 Deals associated with Dapirolizumab pegol

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Systemic Lupus Erythematosus	Phase 3	US	UCB Biopharma SRL	12 Aug 2020
Systemic Lupus Erythematosus	Phase 3	AR	UCB Biopharma SRL	12 Aug 2020
Systemic Lupus Erythematosus	Phase 3	AU	UCB Biopharma SRL	12 Aug 2020
Systemic Lupus Erythematosus	Phase 3	AT	UCB Biopharma SRL	12 Aug 2020
Systemic Lupus Erythematosus	Phase 3	BE	UCB Biopharma SRL	12 Aug 2020
Systemic Lupus Erythematosus	Phase 3	BG	UCB Biopharma SRL	12 Aug 2020
Systemic Lupus Erythematosus	Phase 3	CA	UCB Biopharma SRL	12 Aug 2020
Systemic Lupus Erythematosus	Phase 3	CL	UCB Biopharma SRL	12 Aug 2020
Systemic Lupus Erythematosus	Phase 3	CO	UCB Biopharma SRL	12 Aug 2020
Systemic Lupus Erythematosus	Phase 3	CZ	UCB Biopharma SRL	12 Aug 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02804763 (Pubmed) Manual	Phase 2	Systemic Lupus Erythematosus	-	PBO+SOC	huvrozvsrs(nddizctocp) = akvytthmki utxmiwfcry (wmfmlrksbd ) Not Met View more	Negative	03 Nov 2021
				dapirolizumab pegol 6 mg/kg+SOC	huvrozvsrs(nddizctocp) = twxiunhxhk utxmiwfcry (wmfmlrksbd ) Not Met View more
NCT01764594 (Pubmed \| Arthritis Rheumatol) Manual	Phase 1	Systemic Lupus Erythematosus	24	dapirolizumab pegol	ktclrramak(yttapekfwl) = hvnoywobke gfntweitrw (hdtixvslza ) View more	Positive	01 Nov 2017
				Placebo	ktclrramak(pjsgvwopdd) = raommtlccp ztrzghbsox (mrpsuuidut ) View more
NCT01093911 (Pubmed) Manual	Phase 1	Systemic Lupus Erythematosus	28	CDP7657 (healthy individuals)	pxuxdkmbai(cbgdcwzuyn) = iurqfomfpc wfjzugjfna (itgteqvrzr )	Positive	16 Mar 2015
				Placebo (healthy individuals)	-

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