AstraZeneca, along with its global biologics research and development arm, MedImmune, will present positive data today from the Phase II trial of anifrolumab for the treatment of moderate-to-severe systemic lupus erythematosus (SLE or lupus) at the American College of Rheumatology (ACR) 2015 Annual Scientific Meeting in San Francisco.
The trial randomised 305 adults with seropositive moderate-to-severe systemic lupus erythematosus (SLE), who were taking standard of care medication, to receive one of two doses of intravenous anifrolumab or placebo every four weeks for 48 weeks. Results showed that the study met its main goal 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 oral corticosteroid (OCS) use between day 85 and day 169. AstraZeneca noted that responses occurred for 34.4 percent of patients receiving the lower dose of anifrolumab and for 28.8 percent given the higher dose, versus 17.6 percent for placebo.
The company said that the trial also met both secondary efficacy endpoints measuring responses at day 365. According to AstraZeneca, 51.5 percent of patients receiving the lower dose of anifrolumab and 38.5 percent administered the higher dose of the therapy achieved SRI4 response at day 365 with sustained reduction of OCS, compared with 25.5 percent of those given placebo. In addition, the study met its other secondary endpoint of a reduction of OCS use to at the most 7.5 mg/day by day 365 in those patients taking at least 10 mg/day of OCS at baseline.
Principal investigator Richard A. Furie remarked "we have been eagerly awaiting clinical data of this magnitude for many years." Anifrolumab, formerly known as MEDI-546, is a fully human monoclonal antibody that binds to subunit 1 of the type I interferon receptor. "These results provide very compelling evidence that blocking the type 1 interferon system with an inhibitor of the type I interferon receptor is a promising strategy for the treatment of SLE and support the progression of anifrolumab into Phase III," Furie added.
AstraZeneca added "greater efficacy" was seen in a pre-defined subgroup of patients with elevated interferon gene signature at baseline. The company indicated that anifrolumab is being developed with an interferon gene signature test designed to identify patients who may be more likely to benefit from treatment.
According to AstraZeneca, adverse events were similar across the treatment groups, with serious adverse events reported in 18.8 percent of patients receiving placebo and 16.7 percent of those in the pooled anifrolumab groups. However, the drugmaker added that a dosage-dependent increase in Herpes zoster cases and a greater number of influenza infections were observed for patients receiving anifrolumab. Bing Yao, senior vice president of R&D for respiratory, inflammation and autoimmunity at AstraZeneca's MedImmune unit, said the conditions were readily treated with antivirals.
A Phase III programme for anifrolumab, which AstraZeneca has suggested could garner peak annual sales of around $1 billion, was initiated in July. More recently, the FDA granted the therapy fast track status.
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