UCB, Biogen lupus drug scores in phase 3 trial

UCB and Biogen say their first phase 3 trial of their systemic lupus erythematosus (SLE) candidate dapirolizumab pegol was a success, and a second is now expected to start before the end of the year.

Data from the PHOENYCS GO study in moderate to severe SLE patients isn't available yet, but the partners say dapirolizumab pegol achieved a "clinical improvement" in the primary and secondary endpoints, including measures of disease activity and flares.

The 321-subject trial is comparing the anti-CD40L antibody to placebo on top of standard care in SLE patients, with the primary endpoint response on the BILAG 2004-based Composite Lupus Assessment (BICLA) scale at week 48.

As usual, a second trial will be needed before UCB and Biogen can file dapirolizumab pegol with regulators. It will be called PHOENICS FLY and get underway as patients in the first phase 3 study are followed in a long-term open-label study.

If it makes it to market, the drug could provide a much-needed new treatment for SLE, a chronic, autoimmune disease that affects multiple organ systems and disproportionately affects women.

It is highly debilitating – with a range of symptoms extending from rash and arthritis to seizures and psychosis – and affects more than 200,000 people in the US, according to the Centers for Disease Control and Prevention (CDC).

Current treatment for SLE relies on old drugs like hydroxychloroquine and corticosteroids, although the armamentarium has been expanded in recent years, with newer medicines like GSK's Benlysta (belimumab), AstraZeneca's Saphnelo (anifrolumab), and Otsuka's Lupkynis (voclosporin).

For Biogen, dapirolizumab pegol is part of a push into the inflammatory and immunological diseases area and diversification away from its traditional focus on central nervous system diseases.

Other candidates include anti-BDCA2 antibody litifilimab in phase 3 for SLE and phase 2 for cutaneous lupus erythematosus (CLE) – also partnered with UCB – and felzartamab, an anti-CD38 antibody for IgA nephropathy (IgAN) and other diseases, licensed from Human Immunology Biosciences (HI-Bio) for $1.15 billion upfront earlier this year.

"Our hypothesis is that impacting the CD40L pathway, a central mechanism in immune response, would translate to significant impact on SLE disease burden," said Diana Gallagher, who is leading Biogen's immunology R&D activities.

"These results demonstrate that dapirolizumab pegol has the promise to provide meaningful benefit in this serious, chronic, and often devastating disease."

Other CD40L-directed therapies in the industry pipeline include Sanofi's frexalimab – in phase 3 for multiple sclerosis and phase 2 for SLE and type 1 diabetes – and Novartis' iscalimab, which was in testing for various indications including SLE, but now only has Sjogren's syndrome listed in Novartis' latest pipeline update.

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