If you've ever had food stuck in your throat, you know it's scary. Now imagine that happening regularly, every time you eat. That's the reality for people with eosinophilic esophagitis, or EoE, a chronic condition where white blood cells build up in the esophagus, causing inflammation, damage, and difficulty swallowing. It's not just uncomfortable; it can be debilitating.
On Thursday, AstraZeneca Plc (NYSE: PLC) and Amgen Inc. (NASDAQ: AMGN) shared some promising news for these patients. Their drug Tezspire (tezepelumab) delivered statistically significant and clinically meaningful improvements in a Phase 3 trial called CROSSING, which tested the drug in people with symptomatic and histologically active EoE.
The trial compared Tezspire, given as a subcutaneous injection every four weeks, against a placebo. The results, measured at week 24, showed the drug hit both co-primary endpoints: histologic remission (meaning the esophagus looked healthier under a microscope) and a reduction in the frequency and severity of dysphagia (that's the medical term for trouble swallowing). Importantly, these improvements were sustained through week 52, and they were seen across both doses tested.
“The impressive results from the CROSSING trial sustained over 52 weeks demonstrate that tezepelumab, taken every four weeks, could provide a new approach to treating EoE, with the potential to help more patients achieve remission and symptom improvement,” said Arjan Bredenoord, the trial's primary investigator.
EoE is more common than you might think. It affects more than 470,000 people in the U.S., and the prevalence has increased fivefold since 2009. That's a lot of people struggling with something as basic as eating.
Tezspire is already on the market for other conditions. It's a first-in-class human monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP), a protein that plays a key role in driving inflammation. It's currently approved for severe asthma in the U.S., EU, China, Japan, and more than 70 other countries, and for chronic rhinosinusitis with nasal polyps in the U.S., EU, China, and Japan.
The safety profile of Tezspire in the CROSSING trial was generally consistent with its approved indications, which is good news for a drug that could be used long-term.
This isn't the only thing the companies are working on. They're also running Phase 3 trials called JOURNEY and EMBARK to test Tezspire in chronic obstructive pulmonary disease (COPD), another tough respiratory condition.
Investors seemed to take the news in stride. In premarket trading on Thursday, Amgen shares were down 1.49% at $433.80, and AstraZeneca shares were down 0.63% at $165.22.
For patients with EoE, this could be a big deal. Current treatments often involve dietary changes, proton pump inhibitors, or swallowed steroids, which don't work for everyone. A biologic that targets the underlying inflammation could offer a new option, and one that only needs to be taken once a month. That's a convenience factor that could make a real difference in adherence and quality of life.
Of course, these are just trial results. The data will need to be reviewed by regulators, and there's no guarantee the drug will be approved for EoE. But for a condition that has few good treatment options, this is a step in the right direction.
