Recently, Immunomedics Inc. (IMMU) and its Belgian partner UCB presented encouraging data from a mid-stage study of their lupus drug candidate epratuzumab at the European League Against Rheumatism (EULAR) meeting in Rome. The data revealed a significant reduction in disease activity in patients suffering from moderate to severe active systemic lupus erythematosus (SLE).
The 12-week study (n=74), known as EMBLEM, evaluated the safety and efficacy of epratuzumab, and also aimed to define a dose and regimen in SLE patients. The primary goal of the multicenter, randomized, placebo-controlled study was to measure the candidate's combined response index endpoint, including several indices of disease activity. The findings revealed statistical significance compared to placebo.
The responder rates were twice compared to placebo in both the 600 mg weekly group as well as the combined group of all the enrolled patients who were treated with a cumulative dose of 2,400 mg. Superiority was observed after 8 weeks of treatment with further improvement after 12 weeks.
Epratuzumab has been licensed to UCB for the SLE indication by the New-Jersey based, Immunomedics. UCB possesses the rights and is responsible for the development and commercialization of the candidate for all autoimmune disorders. The candidate, which is being evaluated for the treatment of non-Hodgkin’s lymphoma and autoimmune diseases including SLE and Sjögren’s Syndrome, has received fast track status for SLE treatment by the US Food and Drug Administration (FDA).
SLE, commonly known as lupus, is characterized by periods of flares or exacerbations, interspersed with periods of remission. According to data from the Lupus Foundation of America, approximately 1.5–2 million Americans are affected by lupus. Women form 90% of the affected population.
The market for SLE has a huge unmet need with Human Genome’s (HGSI) Benlysta being the most eagerly awaited candidate in the space. Human Genome and partner GlaxoSmithKline plc (GSK) recently filed for both European as well as FDA approval of the drug. Benlysta, if approved, would be the first new lupus drug to be approved in 50 years.
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