Tezspire succeeds in phase 3 esophagitis trial, opening potential blockbuster opportunity

Tezspire, developed by AstraZeneca and Amgen, met its goals in a phase 3 trial for eosinophilic esophagitis.

According to BioPharma Dive on the 27th local time, the companies said Tezspire met all primary and secondary endpoints in a phase 3 trial involving patients with eosinophilic esophagitis (EoE).

Tezspire is an antibody therapy already approved for severe asthma and chronic rhinosinusitis. The success opens the possibility of expanding it into a third indication.

The companies did not disclose specific figures but said the treatment showed “statistically significant and clinically meaningful improvements” in measures of disease activity and severity, as well as symptoms.

The effects were assessed at 24 weeks and were found to be maintained for 1 year. The companies plan to share the results with regulatory authorities and present them at future medical meetings.

Tezspire is a monoclonal antibody that blocks the activity of TSLP, a protein involved in inflammatory diseases. Last year, Amgen and AstraZeneca each recorded more than $1 billion in Tezspire sales.

AstraZeneca generated $390 million in sales in the second quarter alone this year. That represented a 45% increase from the same period a year earlier.

Eosinophilic esophagitis is a disease in which white blood cells called eosinophils accumulate in the lining of the esophagus, causing difficulty swallowing. Patients receive proton pump inhibitors or topical steroids, but about half do not respond to initial treatment.

AstraZeneca said more than 470,000 people in the United States are affected by the disease and that its prevalence is increasing.

Matt Phipps, an analyst at William Blair, said these factors support “an attractive third indication with blockbuster potential.”

If Tezspire is approved for eosinophilic esophagitis, it will compete directly with Dupixent from Sanofi and Regeneron. Dupixent is an anti-inflammatory therapy approved for multiple diseases.

Phipps said Regeneron and Sanofi have also described eosinophilic esophagitis as a “meaningful growth driver” with significant sales potential.

The success is expected to support AstraZeneca’s goal of reaching $80 billion in annual revenue by 2030. Tezspire is also one of Amgen’s key growth drivers.