AstraZeneca’s new medicine anifrolumab has achieved primary endpoint in the phase III Tulip 2 trial of systemic lupus erythematosus (SLE).
Anifrolumab has demonstrated a statistically-significant and clinically-meaningful reduction in disease activity compared to placebo in the trial. Both arms received standard of care in the study.
Anifrolumab is a fully human monoclonal antibody, which binds to subunit 1 of the type I interferon receptor, enabling to block the activity of all type I interferons including IFN-alpha, IFN-beta and IFN-omega. Type I interferons are cytokines engaged in the inflammatory pathways.
British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) has been used for the measurement of reduction at week 52.
According to the company, the BICLA needs improvement in all organs with disease activity at baseline with no new flares and the safety profile of anifrolumab was consistent with previous trials.
Tulip 2 was the second phase III trial designed to evaluate the safety and efficacy of anifrolumab as a treatment for adults with moderate-to-severe SLE.
The positive BICLA response in Tulip 2 was in line with a pre-specified analysis of the earlier phase III Tulip 1 trial, which failed to reach its primary endpoint of SLE Responder Index 4 (SRI4).
The pivotal Tulip (treatment of uncontrolled lupus via the interferon pathway) programme is comprised of two phase III clinical trials, including Tulip1 and Tulip 2, which assessed the efficacy and safety of anifrolumab versus placebo in patients with moderately-to-severely active autoantibody-positive SLE who were receiving standard of care treatment.
AstraZeneca bioPharmaceuticals R&D executive vice president Mene Pangalos said: “Systemic lupus erythematosus is a debilitating autoimmune disease, but only one new treatment has been approved in the last 60 years.
“These are important results and we will now review the full data set and explore pathways to bring this potential new treatment to patients.”