Autoantibody

Vera Therapeutics Completes Patient Enrollment in Phase 2b ORIGIN Clinical Trial of Atacicept for the Treatment of IgA Nephropathy

Retrieved on: 
Wednesday, July 6, 2022

This builds on the already compelling disease-modifying dose-dependent activity and well-tolerated safety profile for atacicept.

Key Points: 
  • This builds on the already compelling disease-modifying dose-dependent activity and well-tolerated safety profile for atacicept.
  • We look forward to the results of the ORIGIN trial which will be a first for the field.
  • Subjects were randomized 2:2:1:2 to atacicept 150 mg, atacicept 75 mg, atacicept 25 mg, or matching placebo.
  • Atacicept showed a dose-dependent effect on key biomarkers and clinical markers in a Phase 2a clinical study.

Exagen Releases Largest Comparative Utility Study in Lupus Diagnostics Confirming AVISE® Lupus Delivers Unparalleled Utility

Retrieved on: 
Tuesday, July 5, 2022

The Complement Activation Products vs. Standard ANA Testing: Treatment Outcomes, Diagnosis, and Economic Impact in Systemic Lupus Erythematosus (CAPSTONE) study is the largest comparative utility study in lupus diagnosis and was published in the Journal of Managed Care & Specialty Pharmacy.

Key Points: 
  • The Complement Activation Products vs. Standard ANA Testing: Treatment Outcomes, Diagnosis, and Economic Impact in Systemic Lupus Erythematosus (CAPSTONE) study is the largest comparative utility study in lupus diagnosis and was published in the Journal of Managed Care & Specialty Pharmacy.
  • For either a positive or negative test result, patients receive the most clinically effective information from the AVISE Lupus test.
  • The study clearly establishes the superiority of the AVISE Lupus test for patients, providers and payors.
  • Exagen cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements.

New Analysis Finds UPLIZNA® (inebilizumab) Effective Among European Populations with Neuromyelitis Optica Spectrum Disorder (NMOSD)

Retrieved on: 
Friday, June 24, 2022

These data are being presented during the 8th Congress of the European Academy of Neurology (EAN), June 25-28 in Vienna.

Key Points: 
  • These data are being presented during the 8th Congress of the European Academy of Neurology (EAN), June 25-28 in Vienna.
  • Fewer NMOSD-related hospitalisations were reported among those receiving UPLIZNA compared to those treated with placebo (mean, EU: 1.0 vs 2.0; non-EU: 1.0 vs 1.33).
  • NMOSD is a unifying term for neuromyelitis optica (NMO) and related syndromes.
  • Baranello RJ, Avasarala, JR. Neuromyelitis optica spectrum disorders with and without aquaporin 4 antibody: Characterization, differential diagnosis, and recent advances.

Lupus Research Alliance Awards 2022 Lupus Insight Prize to Immunologist Dr. Akiko Iwasaki

Retrieved on: 
Thursday, June 23, 2022

SAN FRANCISCO, June 23, 2022 /PRNewswire/ -- The Lupus Research Alliance (LRA) awarded its 2022 Lupus Insight Prize (LIP) to Akiko Iwasaki, PhD, for her discovery of the link between endogenous retroviruses and systemic lupus erythematosus (SLE). The award was presented to Dr. Iwasaki at the 22nd Annual Meeting of the Federation of Clinical Immunology Societies (FOCIS 2022) by Judith James, MD, PhD, LRA Scientific Advisory Board member and Lou Kerr Chair in Biomedical Research and Chair of the Arthritis and Clinical Immunology Program at the Oklahoma Medical Research Foundation. The $100,000 award recognizes and honors an outstanding investigator who has, within the past five years, published a novel and important research insight into lupus that advances our understanding of this disease and could open new avenues for lupus diagnosis and treatment.

Key Points: 
  • SAN FRANCISCO, June 23, 2022 /PRNewswire/ -- The Lupus Research Alliance (LRA) awarded its 2022 Lupus Insight Prize (LIP) to Akiko Iwasaki, PhD, for her discovery of the link between endogenous retroviruses and systemic lupus erythematosus (SLE).
  • "I am honored to receive this prestigious award, and I sincerely thank the Lupus Research Alliance for recognizing our research.
  • The Lupus Research Alliance, the largest nongovernmental, nonprofit research organization dedicated to lupus research worldwide, aims to transform treatment while advancing toward a cure by funding the most innovative lupus research in the world.
  • Because the Lupus Research Alliance's Board of Directors funds all administrative and fundraising costs, 100 percent of all donations goes to support lupus research programs.

FDA Clears Thermo Scientific EliA RNA Pol III and EliA Rib-P Tests for Use in U.S.

Retrieved on: 
Thursday, June 9, 2022

Thermo Scientific EliA RNA Pol III and EliA Rib-P tests have been cleared by the U.S. Food & Drug Administration (FDA) for aiding in the diagnosis of Systemic Sclerosis (SSc; scleroderma) and Systemic Lupus Erythematosus (SLE).

Key Points: 
  • Thermo Scientific EliA RNA Pol III and EliA Rib-P tests have been cleared by the U.S. Food & Drug Administration (FDA) for aiding in the diagnosis of Systemic Sclerosis (SSc; scleroderma) and Systemic Lupus Erythematosus (SLE).
  • [2] The EliA RNA Pol III test completes a criteria based EliA SSc panel and is the first fully automated RNA Polymerase test available in the U.S.
    A subset of SLE patients present with monospecific Ribosomal P antibodies.
  • The new EliA RNA Pol III and EliA Rib-P tests have been designed to improve the differentiation of SSc and SLE from other connective tissue diseases.
  • For more information on the Thermo Scientific EliA RNA Pol III and EliA Rib-P tests, please visit https://www.thermofisher.com/phadia .

Vera Therapeutics Reports Positive Interim Phase 2 Data Showing MAU868 Has Significant BK Antiviral Activity in Kidney Transplant Patients

Retrieved on: 
Saturday, June 4, 2022

BK Virus (BKV) is a polyoma virus that can be reactivated in settings of immunosuppression, such as in kidney transplant.

Key Points: 
  • BK Virus (BKV) is a polyoma virus that can be reactivated in settings of immunosuppression, such as in kidney transplant.
  • It is a leading cause of kidney transplant loss and transplant-associated morbidity; there are currently no approved treatments for BKV.
  • MAU868 is currently undergoing a randomized, double-blind, placebo-controlled Phase 2 clinical trial to assess the safety, pharmacokinetics, and efficacy for the treatment of BKV in kidney transplant patients.
  • Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant.

Vera Therapeutics to Participate in the 2022 Jefferies Healthcare Conference

Retrieved on: 
Thursday, June 2, 2022

Vera Therapeutics is a late-stage biotechnology company focused on developing treatments for serious immunological diseases.

Key Points: 
  • Vera Therapeutics is a late-stage biotechnology company focused on developing treatments for serious immunological diseases.
  • Veras mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients.
  • In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful.
  • Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant.

Horizon Therapeutics plc to Highlight Data and Education on Thyroid Eye Disease (TED) at the Endocrine Society (ENDO) 2022 Annual Conference

Retrieved on: 
Thursday, June 2, 2022

ET in ENDOExpo Theater 1, titled Evolution of Thyroid Eye Disease (TED) Treatment With Teprotumumab: Translating Bench to Bedside with Terry J. Smith, M.D., Michigan Medicine Eye Plastic, Facial Cosmetic & Orbital Surgery, Kellogg Eye Center, University of Michigan Medical School.

Key Points: 
  • ET in ENDOExpo Theater 1, titled Evolution of Thyroid Eye Disease (TED) Treatment With Teprotumumab: Translating Bench to Bedside with Terry J. Smith, M.D., Michigan Medicine Eye Plastic, Facial Cosmetic & Orbital Surgery, Kellogg Eye Center, University of Michigan Medical School.
  • The event, Achieving Gold in the Co-Management of Thyroid Eye Disease (TED), will be held in The Career and Communications Center in the Exhibit Hall on Saturday, June 11 at 11 a.m.
  • Gail will also be sharing her story between 11 a.m. and 4 p.m.
  • After a harrowing two-and-a-half-year quest for answers, she was diagnosed with Graves disease in 1990, just two years before winning her first Olympic gold medal.

argenx Announces the UK MHRA has Granted Early Access to Efgartigimod for Generalized Myasthenia Gravis

Retrieved on: 
Tuesday, May 31, 2022

The EAMS program offers early access to innovative medicines for patients who are experiencing a significant unmet medical need, before the MHRA approves a formal marketing authorization application (MAA) and prior to reimbursement.

Key Points: 
  • The EAMS program offers early access to innovative medicines for patients who are experiencing a significant unmet medical need, before the MHRA approves a formal marketing authorization application (MAA) and prior to reimbursement.
  • Despite currently available treatments, gMG patients in the UK face a significant disease burden and many struggle to manage the debilitating symptoms of this rare autoimmune disease.
  • We look forward to continued collaboration with the agency to make this innovative therapy available to UK patients as soon as possible.
  • Efgartigimod was previously granted a PIM designation by the MHRA in November 2021.

Antibody Testing Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Products, Indication, End User - ResearchAndMarkets.com

Retrieved on: 
Thursday, May 26, 2022

The "Antibody Testing Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Products, Indication , End User" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Antibody Testing Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Products, Indication , End User" report has been added to ResearchAndMarkets.com's offering.
  • However, the antibody testing market is likely to get impacted by the limitations of antibody screening tests during the forecast period.
  • Additionally, growing government support is fueling the growth of antibody testing, which influences the development of the global antibody testing market.
  • In long run antibody testing market would have significant growth prospects as many market players have received emergency use authorization for their newly developed antibody tests.