Biogen and Belgian partner UCB announce positive data from late-stage trial of lupus treatment

By Ciara Linnane

Chronic autoimmune disease mostly affects women

Biogen Inc.'s stock was slightly lower Tuesday, shedding early gains made after the company and Belgian partner UCB announced positive results in a late-stage trial of a treatment for the chronic autoimmune disease lupus.

The Phase 3 trial sought to evaluate dapirolizumab pegol plus standard of care in people living with moderate-to-severe lupus and met its primary goal of improvement after 48 weeks compared with placebo in addition to standard of care.

The trial also met secondary endpoints measuring disease activity and flares. UCB (BE:UCB) and Biogen (BIIB) said they would initiate a second Phase 3 trial in 2024. Patients in the first study will continue to be tracked in a long-term, open-label study. Details of the outstanding Phase 3 trial will be presented at a coming medical conference, said Biogen and UCB.

"These positive results with dapirolizumab pegol represent encouraging progress in the development of medicines that can improve the lives of those living with lupus, an area that remains one of high unmet medical need and where women are disproportionately affected," said Fiona du Monceau, head of patient evidence at Brussels-based UCB.

Lupus is a painful disease that can affect multiple organ systems with periods of illness or flares that alternate with periods of inactivity. Symptoms can include rash, arthritis, anemia, thrombocytopenia, serositis, nephritis, seizures or psychosis.

The illness is associated with a greater risk of death from causes such as infection and cardiovascular disease.

About 90% of people living with lupus are women and most start to show symptoms around the ages of 15 to 55.

Biogen's stock has fallen 24.7% in the year to date, while the SPDR S&P Biotech ETF XBI has gained 9.8% and the S&P 500 SPX has gained 19.9%.

-Ciara Linnane

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09-24-24 1104ET

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