Arthritis and Rheumatology publishes positive Phase II data on anifrolumab in lupus

14 November 2016

Gaithersburg, Md, 14 November 2016 - AstraZeneca and its global biologics research and development arm, MedImmune, today announced that Arthritis and Rheumatology has published positive results from the Phase II trial of anifrolumab, an investigational monoclonal antibody that blocks all type 1 interferons, for the treatment of moderate to severe systemic lupus erythematosus (SLE or lupus).

The study met its primary and secondary endpoints, with anifrolumab treatment resulting in significantly greater rates of improvement across a broad range of composite and organ-specific disease activity measures, as well as a reduction in oral corticosteroid use (in the 300 mg group), compared with placebo.  Detailed results and safety information from the Phase II trial as published in Arthritis and Rheumatology can be viewed here.

Bing Yao, Senior Vice President, Research and Development for Respiratory, Inflammation and Autoimmunity, MedImmune, said: “Publication of these data in Arthritis and Rheumatology underscores the importance of anifrolumab as a potential new treatment for people with lupus, a serious and debilitating disease with clear unmet need. Our Phase II trial has provided a strong foundation from which our Phase III trials were designed. We are actively enrolling in those Phase III trials now, and we look forward to further exploring the role of type I interferons in the treatment of lupus and building on these promising results.”

Principal Investigator Richard A. Furie, MD, Chief, Division of Rheumatology, Northwell Health, said: “Although there have been many recent treatment advances for autoimmune conditions, innovations in lupus therapies have lagged behind, leaving a significant need as most current options have limited efficacy or undesired side effects. These positive data from the anifrolumab Phase II trial provide compelling evidence that blocking type 1 interferons is a promising strategy for the treatment of SLE and could provide hope for the lupus community.”

In the Phase II trial, serious adverse events reported were similar across the three treatment groups. A dosage-dependent increase in Herpes zoster cases (Placebo: 2.0%; 300mg: 5.1%; 1000mg: 9.5%) which responded promptly to antiviral therapy, and a greater number of events reported as influenza (placebo: 2.0%; 300mg: 6.1%; 1,000 mg: 7.6%) were observed for patients receiving anifrolumab.

AstraZeneca and MedImmune previously announced the Phase II data at the American College of Rheumatology 2015 Annual Scientific Meeting.

NOTES TO EDITORS

About Anifrolumab

Anifrolumab is an investigational, fully human monoclonal antibody that binds to subunit 1 of the Type I interferon (IFN) receptor, inhibiting the activity of all type I IFNs, which play a central role in lupus, including IFN-α, IFN-β and IFN-ω. Anifrolumab is the only anti-type-I IFN receptor approach currently in development for SLE. Anifrolumab is currently in Phase III development for SLE. The US Food and Drug Administration has granted anifrolumab Fast- Track designation for SLE, which expedites the review process to facilitate the development of medicine candidates that treat serious conditions and fill an unmet medical need. A Phase II trial in lupus nephritis and a Phase I trial in a subcutaneous route of administration are also ongoing. Anifrolumab is being developed with a type I IFN gene signature test designed to identify patients who may be more likely to benefit from treatment.

About the Phase II Anifrolumab Trial

The efficacy and safety of anifrolumab was evaluated in a Phase II, randomized, double-blind, placebo-controlled trial, known as MUSE, in which 305 adults with seropositive moderate to severe SLE receiving standard-of-care medication were randomized to receive intravenous (IV) anifrolumab 300 mg or 1,000 mg every four weeks or placebo (PBO) every four weeks for 48 weeks. Patients were stratified by SLE Disease Activity Index (SLEDAI) score, oral corticosteroid (OCS) dosage, and IFN gene signature (IFN high vs. IFN low) based on a 4-gene expression assay. The trial met its primary endpoint of difference in the percentage of patients who achieved response as measured by the SLE Responder Index 4 (SRI4) at Day 169, along with a sustained reduction of OCS use between Day 85 and day 169. The trial also met both secondary efficacy endpoints measuring responses at Day 365.

The SRI4 is recognised by health authorities and combines criteria from three internationally validated disease activity measures, representing a clinically significant improvement in lupus disease activity. To achieve SRI4 response, an individual with lupus must have at least a 4-point improvement on the SLE Disease Activity-2K (SLEDAI-2K) score and have no worsening on the Physician Global Assessment of disease activity and the BILAG (British Isles Lupus Assessment Group) disease activity index. Disease activity was also assessed by Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), BILAG-Based Composite Lupus Assessment (BICLA), and 28-joint count.

About the Phase III TULIP Programme

The TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway) programme includes two Phase III clinical trials that will evaluate the efficacy and safety of anifrolumab versus placebo in patients with moderately to severely active, autoantibody-positive SLE, who are receiving standard of care treatment. The Phase III trials will assess the effect of anifrolumab in reducing disease activity (as measured by the SRI4), decreasing use of OCS, improving skin manifestations (as measured by CLASI) and reducing flares. For more information (in the US only), visit www.whatistulip.com

About Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosus (SLE), or lupus, is an autoimmune disease in which the immune system produces antibodies that, instead of targeting viruses or other foreign invaders, attack healthy tissue in the body, including skin, joints, the brain and blood vessels. SLE can cause a range of symptoms, including pain, rashes, fatigue, swelling in joints, and fevers. It is associated with a greater risk of death from causes such as infection and cardiovascular disease.

About MedImmune
MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Respiratory & Autoimmunity, Cardiovascular & Metabolic Diseases, Oncology, and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centres, with additional sites in Cambridge, UK and Mountain View, CA. For more information, please visit www.medimmune.com.

MEDIA CONTACT:

Rebecca Einhorn, MedImmune
einhornr@medimmune.com
(301) 398-1802

Susannah Buddington, AstraZeneca
susannah.budington@astrazeneca.com
(301) 980-7482