Amgen and AstraZeneca have reported complete results from the Phase III CROSSING clinical trial of Tezspire (tezepelumab-ekko) for adolescent and adult patients with uncontrolled, symptomatic eosinophilic oesophagitis (EoE).
Subcutaneous administration of the treatment every four weeks met co-primary endpoints at week 24, producing statistically significant improvements in tissue remission and dysphagia that continued through week 52.
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At week 24, histologic remission occurred in 64.8% of patients receiving the 210mg dose and 68.9% on the 420mg dose, compared with 3.5% in the placebo cohort.
Patients also registered symptom reductions on the Dysphagia Symptom Questionnaire of 18.8 points on 210mg and 22.0 points on 420mg, versus 14.7 points for placebo.
At week 52, remission persisted at 67.8% and 63.3% across the respective dosing groups against 5.4% for placebo, while total endoscopic remission reached 34.4% and 29.5% compared with 4.1% on placebo.
Amgen AI and data research and development executive vice-president Jay Bradner said: “A new treatment approach is needed for people living with eosinophilic oesophagitis, half of whom continue to experience uncontrolled symptoms despite standard treatment.
“We’re pleased with the statistically significant and clinically meaningful, sustained improvements seen in CROSSING.
“As we continue to study Tezspire across epithelial-driven inflammatory diseases, our focus remains on translating the science behind TSLP inhibition into meaningful outcomes for patients.”
The randomised, double-blind trial evaluated 368 participants aged 12 to 80 years who were permitted to continue stable background therapies.
The reported safety profile was consistent with approved uses, with diarrhoea, headache, and nasopharyngitis representing the most frequent adverse events.
Tezspire blocks thymic stromal lymphopoietin to reduce epithelial inflammation.
It holds approvals for severe asthma in China, the EU, Japan, the US, and more than 70 other nations, as well as for chronic rhinosinusitis with nasal polyps in China, the EU, Japan, and the US.
Under its partnership, Amgen manufactures the therapy worldwide. The companies will split costs and profits equally, with a mid-single-digit royalty to Amgen.
Last month, Amgen’s Phase III Sjögren’s disease trial met its primary endpoint, marking the latest sign that the indication could be set for its first-ever drug approvals.
