Biogen (BIIB.US) and UCB's late-stage trial of lupus drug dapilumab monoclonal antibody successful, reversing early failure gloom.

Biogen (BIIB.US) and its Belgian partner UCB announced on Tuesday that their experimental lupus treatment, daratumumab, achieved the main goal in late-stage trials, a surprising result after the drug had failed in earlier mid-stage studies. If this success is confirmed in a second late-stage study, it could provide a new treatment option for lupus patients, especially in a field where trial failures and approved therapies are very limited. The two companies plan to initiate the second study later this year. In a study of 321 patients, the companies reported that daratumumab, when taken with corticosteroids and immunosuppressive drugs, resulted in a more significant reduction in disease activity compared to a placebo. Lupus is a disease that primarily affects women, is unpredictable, and causes a range of symptoms. Approved treatments include Saphnelo from Astrazeneca PLC Sponsored ADR (AZN.US) and Benlysta from GlaxoSmithKline plc Sponsored ADR (GSK.US). Adam Myers, head of immunology and new diseases at Biogen, stated in an interview before the data was released that despite some new therapies being approved and patients making substantial progress, there is still unmet need. Myers added that they often hear comments about lack of significant efficacy or slow onset of action, and their goal is to try to improve treatment options for patients. The drug is being tested on patients with the most common type of lupus, systemic lupus erythematosus, where the immune system attacks the body's own tissues and may lead to organ failure. It is estimated that around 200,000 patients in the United States have this disease. Since the Biogen-UCB drug failed to meet the main goal in a mid-stage trial for patients with moderate to severe active disease in 2018, most Wall Street analysts had excluded this drug from their sales forecasts. In contrast, Saphnelo from Astrazeneca PLC Sponsored ADR was approved in 2021, with sales reaching $280 million in 2023, while Benlysta from GlaxoSmithKline plc Sponsored ADR was first approved in 2011, with sales of 1.35 billion euros (1.5 billion dollars) last year. Several other pharmaceutical companies are also developing experimental lupus drugs.