Amgen's Horizon buyout delivers Sjögren's disease win
Amgen's anti-CD40L drug dazodalibep has shown efficacy in a phase 3 trial in Sjögren's disease (SjD), raising hopes for a treatment that can alter the course of the debilitating autoimmune disorder.
In the OASIZ 301 study – one of two Amgen is carrying out on dazodalibep in SjD – the drug met its primary objective of reducing systemic disease activity at week 48, as measured by the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), in patients with moderate-to-severe SjD. Adverse events in the trial were mild to moderate, with few patients discontinuing treatment.
Specific details of the results are not yet available, and Amgen still has to wait for data from a second phase 3 study (OASIZ 303) before it can consider regulatory filings, with that readout now expected before the end of the year. Nevertheless, the announcement bodes well for a step up in treatment options for SjD, which causes dryness in mucosal surfaces like the eyes and mouth, as well as organ damage and an increased risk of life-threatening cancers.
There are currently no FDA-approved medicines for SjD, and patients are currently managed with artificial tears and saliva substitutes, medications to stimulate tear and saliva production, painkillers, and immunosuppressant drugs if their symptoms are severe.
Several promising disease-modifying candidates are coming through the industry pipeline, however, including Novartis' BLyS/BAFF-targeting ianalumab, RemeGen's BLyS/BAFF and APRIL-targeting drug telitacicept, and Johnson & Johnson's FcRn inhibitor nipocalimab. Novartis was also developing an anti-CD40 antibody, iscalimab, for SjD, but abandoned the programme last year after disappointing phase 2 results.
Meanwhile, Argenx's FcRn blocker Vyvgart (efgartigimod alfa) and Bristol Myers Squibb TYK2 inhibitor Sotyktu (deucravacitinib) are also running late-stage studies of these already-marketed drugs in the disorder.
"The rapid and sustained improvement observed in systemic disease activity reinforces our confidence in dazodalibep and the broader phase 3 programme as we work to deliver a new, highly differentiated option for people living with this debilitating autoimmune disease," said Jay Bradner, Amgen's head of R&D, AI, and data.
The disorder affects about 1% of the global population and predominantly affects women.
Dazodalibep is one of the assets included in Amgen's near-$28 billion takeover of Horizon Pharma in 2023, which also gave it Tepezza (teprotumumab) for thyroid eye disease (TED), gout therapy Krystexxa (pegloticase), and Uplizna (inebilizumab) for neuromyelitis optica spectrum disorder (NMOSD).
At the moment, Amgen is not pursuing the development of the drug for other indications, although it has previously been tested in rheumatoid arthritis.
