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Jump to Key Points Oct 20 (Reuters) - Amgen and AstraZeneca said on Tuesday their asthma drug helped reduce swallowing difficulties and achieved disease remission in 69% of patients with a type of chronic inflammatory disorder of the esophagus.
The result builds on August data, when AstraZeneca said the drug met the trial's main goals after 24 weeks of treatment by reducing esophageal inflammation and easing swallowing difficulties versus placebo.
• The drug Tezspire is being studied in patients with symptomatic and uncontrolled eosinophilic esophagitis, which causes swelling and irritation in the food pipe, making swallowing difficult and sometimes causing food to get stuck
• The monoclonal antibody blocks a protein called TSLP that drives the inflammatory pathway involved in both asthma and eosinophilic esophagitis
- Tezspire in eosinophilic esophagitis: 69% remission at 24 weeks.
- 210 mg: 65% remission vs 3.5% placebo; 420 mg: 69% vs 3.5%.
- Benefits sustained to 52 weeks; remission 67.8%/63.3% vs 5.4% placebo.
- Dysphagia scores improved 18.8–22 points at 24 weeks vs 14.7 placebo.
- Common AEs: upper respiratory infection, headache, diarrhea; approved severe asthma biologic.
• About 65% on the 210 mg dose and 69% of patients on the 420 mg dose of the drug achieved remission of inflammation at 24 weeks, compared with 3.5% of patients on placebo
• The companies said the benefits were maintained through 52 weeks, with 67.8% of patients on the 210 mg dose and 63.3% on the 420 mg dose achieving disease remission, compared with 5.4% on placebo
• Tezspire reduced swallowing-difficulty scores by 18.8 points at the 210 mg dose and 22 points at the 420 mg dose after 24 weeks, compared with a 14.7-point reduction with placebo
• The most commonly reported side effects were upper respiratory infections, headache and diarrhea
• The drug is already approved in a number of countries as an add-on treatment for severe asthma and competes with Sanofi and Regeneron's blockbuster drug Dupixent
(Reporting by Sahil Pandey in Bengaluru; Editing by Vijay Kishore)
