Biogen-UCB’s lupus drug achieves key goal of late-stage study

By Manas Mishra

(Reuters) – Biogen and its Belgian partner UCB said on Tuesday their experimental lupus drug had met the main goal of a late-stage trial in patients with the chronic disease, a surprising result after the drug failed an earlier mid-stage trial.

This unexpected success, if replicated in a second, more advanced-stage trial, could offer lupus patients a new alternative in an area where there are many trial failures and few approved therapies. The companies plan to begin the second trial later this year.

The drug, called dapirolizumab pegol, showed a more significant reduction in disease activity in the study of 321 patients when given along with treatments such as corticosteroids and drugs that suppress the immune system, compared with a placebo, the companies said.

The disease, which mainly affects women, is unpredictable as it causes a range of symptoms. Approved treatments include AstraZeneca's Saphnelo and GSK's Benlysta.

“There have been significant advances for our patients, particularly with the approval of some of these new therapies. But the reality is that the need remains unmet,” said Adam Myers, head of immunology and emerging disease areas at Biogen, in an interview before the data was released.

“We often hear things about modest efficacy or slower onset of action and our goal is to improve treatment options for our patients,” Myers added.

The drug is being tested on patients with the most common form of lupus, systemic lupus erythematosus, in which the patient's immune system attacks the body's own tissues, potentially leading to organ failure.

According to the federal government, an estimated 200,000 patients in the United States are affected by the disease.

Most Wall Street analysts have removed Biogen-UCB's drug from their sales estimates after it failed to meet the primary goal of a mid-stage trial in patients with moderate to severe disease activity in 2018.

AstraZeneca's Saphnelo, approved in 2021, had sales of $280 million in 2023, while GSK's Benlysta, first approved in 2011, brought in 1.35 billion euros ($1.50 billion) last year. Several other pharmaceutical companies are also developing experimental lupus drugs.

(1 dollar = 0.8991 euros)

(Reporting by Manas Mishra in Bengaluru; Editing by Shailesh Kuber and Alan Barona)