AstraZeneca to present new data from its growing inflammation and autoimmunity pipeline at American College of Rheumatology 2014 annual meeting

tisdag, 11 november 2014

AstraZeneca, with its global biologics research and development arm, MedImmune, will present new data from the company’s growing inflammation and autoimmunity portfolio at the American College of Rheumatology (ACR) 2014 Annual Meeting in Boston, Massachusetts, 14-19 November 2014.

More than 15 abstracts will be featured at the ACR meeting, providing evidence of the depth and continued progress of AstraZeneca’s inflammation and autoimmunity pipeline. Positive Phase III data will be presented on lesinurad in gout, as well as earlier stage data around a number of innovative investigational medicines including sifalimumab and anifrolumab in systemic lupus erythematosus (SLE, or lupus), mavrilimumab in rheumatoid arthritis, and brodalumab in psoriatic arthritis.

Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer, AstraZeneca, said: “The breadth of research we will present at ACR reinforces our commitment to delivering medicines that could help to improve the lives of millions of patients suffering from inflammation and autoimmune diseases. This is an excellent demonstration of our pipeline delivering promising molecules with the potential to address difficult to treat diseases including gout, lupus, rheumatoid arthritis and psoriatic arthritis.

Bahija Jallal, Executive Vice President, MedImmune said: “We are pioneering innovative research and exploring new pathways in both lupus and rheumatoid arthritis. We continue to push scientific boundaries, advancing our understanding of the drivers and mechanisms of these diseases for the benefit of patients.”

Highlights of data being presented include:

  • Lesinurad: Positive top-line results from CLEAR1 and CLEAR2, the pivotal Phase III clinical trials investigating the potential of lesinurad, a selective uric acid re-absorption inhibitor (SURI), as a combination therapy with xanthine oxidase (XO) inhibitor, allopurinol for the treatment of patients with symptomatic gout. The development of lesinurad is potentially important for the 40-70% of gout patients who are not reaching target levels of serum uric acid (sUA) with the current standard of care.
  • Sifalimumab and anifrolumab: MedImmune is currently investigating two different anti-type 1 interferon (IFN) approaches in the clinic as potential treatments for lupus: sifalimumab, which targets IFN-α, and anifrolumab, which targets the type 1 IFN receptor. Positive results from the Phase IIb study evaluating the safety and efficacy of sifalimumab in patients with moderate-to-severe lupus will be presented in a late-breaking oral presentation. In addition, pharmacokinetic and pharmacodynamic data will be presented on both sifalimumab and anifrolumab from two trials of adult Japanese patients with lupus.
  • Mavrilimumab: Positive results from the Phase IIb EARTH EXPLORER I study evaluating the efficacy and safety of mavrilimumab in patients with moderate-to-severe adult-onset rheumatoid arthritis will be presented in four abstracts, including an oral presentation. Mavrilimumab, currently in development by MedImmune, is a novel human monoclonal antibody targeting the GM-CSF receptor, a key pathway driving the rheumatoid arthritis disease process.
  • Brodalumab: Data will be presented from an open-label extension of a Phase II study on the long-term efficacy and safety of brodalumab, a human anti-IL-17 receptor A monoclonal antibody for patients with psoriatic arthritis. Additionally, an analysis to evaluate the reliability and construct validity of the Psoriasis Symptom Inventory in subjects with psoriatic arthritis will also be presented. Brodalumab is being co-developed by Amgen and AstraZeneca.

Key AstraZeneca abstracts to be featured at ACR:

Gout (lesinurad) Abstracts

  • #105 Morlock R, et al. Resource Use and Health Related Quality of Life Burden of Gout Exacerbated By Common Comorbidities: Results from the 2012-2013 National Health and Wellness Survey. General poster session, 8:30 AM – 4:00 PM ET Sunday, 16 November 2014.
  • #180 Paraskos J, et al. Analytical Comparison Between Point of Care Uric Acid Testing Meters. General poster session 8:30 AM – 4:00 PM ET Sunday, 16 November 2014.
  • #901 Morlock R, et al. Rate of Serum Uric Acid (SUA) Assessment in Gout Patients Treated with Urate-Lowering Therapy: Treating to Target? Oral presentation, 4:30 PM – 6:00 PM ET Sunday,16 November 2014.
  • #1165 Morlock R, et al. Evaluation of Symptom Control Among Treated Gout Patients in the United States, United Kingdom, and Germany. General poster session 8:30 AM – 4:00 PM ET Monday, 17 November 2014.
  • #L10 Saag, K, et al. Lesinurad, a Novel Selective Uric Acid Reabsorption Inhibitor, in Two Phase III Clinical Trials: Combination Study of Lesinurad in Allopurinol Standard of Care Inadequate Responders (CLEAR 1 and 2). ACR late-breaking abstract poster display, 9:00 AM – 11:00 AM ET Sunday, 16 November - Tuesday, 18 November. ACR late-breaking abstract poster presentations, 9:00 AM – 11:00 AM ET Tuesday, 18 November 2014.
  • #2963 Tan P, et al. The URAT1 Uric Acid Transporter Is Important in Uric Acid Homeostasis and Its Activity May be Altered in Gout Patients and in Drug-Induced Hyperuricaemia. Oral presentation, 9:00 AM – 10:30 AM ET Wednesday, 19 November 2014.

Lupus (sifalimumab and anifrolumab) Abstracts

  • #719 Morehouse C, et al. Target Modulation of a Type I Interferon (IFN) Gene Signature with Sifalimumab or Anifrolumab in Systemic Lupus Erythematosus (SLE) Patients in Two Open Label Phase 2 Japanese Trials. General poster session, 8:30 AM–4:00 PM ET, Sunday, 16 November 2014.
  • #1619 Drubin D, et al. Interferon Dysregulation in an Academic SLE Cohort Is Associated with Distinct Signaling Differences in Blood Neutrophils Versus PBMCs. General poster session 8:30 AM – 4:00 PM ET Monday, 17 November 2014.
  • # L4 Khamashta, M et al. Safety and Efficacy of Sifalimumab, an Anti IFN-Alpha Monoclonal Antibody, in a Phase 2b Study of Moderate to Severe Systemic Lupus Erythematosus (SLE). Late-breaking abstracts session, 3:45 PM ‒4:00 PM ET, Tuesday, 18 November 2014.

Rheumatoid Arthritis (mavrilimumab) Abstracts

  • #1143 Kern D, et al. Preferences of Biologic Treatment Characteristics Among Rheumatoid Arthritis Patients Who Are Current Biologic Therapy Users. General poster session, 8:30 AM– 4:00 PM ET, Monday, 17 November, 2014.
  • #1485 Kremer J, et al. Analysis of Patient-Reported Outcomes during Treatment with Mavrilimumab, a Human Monoclonal Antibody Targeting GM-CSFRα, in the Randomized Phase 2b Earth Explorer 1 Study. General poster session 8:30 AM–4:00 PM ET Monday, 17 November, 2014.
  • #1486 McInnes I, et al. Rapid Onset of Clinical Benefit Is Associated with a Reduction in Validated Biomarkers of Disease in Patients with Rheumatoid Arthritis Treated with Mavrilimumab, a Human Monoclonal Antibody Targeting GM-CSFRα. General poster session, 8:30 AM – 4:00 PM ET Monday, 17 November 2014.
  • #1496 Wu C, et al. Exposure-Response Analysis for Mavrilimumab Phase IIb Study in RA Patients with Informative Dropout. General poster session, 8:30 AM – 4:00 PM ET Monday, 17 November 2014.
  • #2821 Burmester G, et al. Efficacy and Safety/Tolerability of Mavrilimumab, a Human GM‒CSFRα Monoclonal Antibody in Patients with Rheumatoid Arthritis. Oral presentation, 2:30PM – 4:00 PM ET Tuesday, 18 November 2014.

Psoriatic Arthritis (brodalumab) Abstracts

  • #549 Mease P, et al. Reliability and Construct Validity of the Psoriasis Symptom Inventory in Subjects with Psoriatic Arthritis. General poster session 8:30 AM – 4:00 PM ET Sunday, 16 November 2014.
  • #1557 Genovese M, et al. Clinical Response in Subjects with Psoriatic Arthritis Following One Year of Treatment with Brodalumab, an Anti-Interleukin-17 Receptor Antibody. General poster session 8:30 AM – 4:00 PM ET Monday, 17 November 2014.