UCB, Biogen admit defeat in PhII lupus trial, adding to a string of late-stage failures in the field

A late-stage lupus program at UCB and Biogen has followed several rivals into a wall.

Without providing details, the partners reported that their drug, dapirolizumab pegol (DZP), had failed to meet the primary endpoint, as measured by dose response at 24 weeks on a scale called the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA). The phase IIb trial involved 182 patients suffering from moderately-to-severely active systemic lupus erythematosus, despite standard-of-care treatment. Patients in the study were either given the drug or a placebo, and although investigators cited consistent improvements in patients on the drug, the experimental treatment did not achieve a statistically significant (p-value of 0.06) effect.

Peter Welford

There’s no reason to panic, though, according to Jefferies’ Peter Welford, who labeled the results “not altogether unsurprising given this notoriously difficult to treat indication.”

(W)e understand that consistent, and potentially meaningful improvements were demonstrated across the majority of clinical endpoints compared to placebo, and biomarker data were supportive. Along with partner Biogen, UCB is considering next steps for the programme. DZP was safe and well tolerated. SLE trials have a notoriously high attrition rate, hence we had not ascribed any value to DZP in our valuation.

The sentiment was echoed by investors, with UCB (Euronext Brussels: $UCB) and Biogen $BIIB shares down a mere 1.2% and 1.5% respectively.

Late-stage lupus failures have become a bit of a norm, with Xencor $XNCR, AstraZeneca $AZN and Sanofi’s $SNY Ablynx all conceding in recent months that their drugs failed to make the cut in treating the autoimmune disease.

UCB and Biogen begun their study in 2016 hoping that their anti-CD40L drug — once explored as a treatment for amyotrophic lateral sclerosis — would be different. They will now have a harder time explaining how.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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