There’s one FDA-approved biologic drug for the immunological disorder eosinophilic esophagitis, or EoE. An AstraZeneca and Amgen antibody is bolstering its case to become a competitive alternative.
This drug, Tezspire, met the main and secondary goals of a Phase 3 EoE study, the companies announced Thursday. Those results compared the once-monthly injection with a placebo, not the blockbuster Sanofi drug Dupixent, whose nine approved immunological indications include EoE.
Specific figures from Tezspire’s trial were not disclosed, but AstraZeneca and Amgen said measures at one year were statistically significant and clinically meaningful. The companies added that they plan to present more details at an upcoming medical meeting and share the data with regulators. An approval for Tezspire in EoE would add a third indication with blockbuster sales potential.
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Tezspire is an antibody designed to block TSLP, a signaling protein that plays a role in a range of immunological disorders. EoE develops as eosinophils, a type of white blood cell, build up in the lining of the esophagus. The resulting inflammation makes swallowing difficult. Food often gets stuck in the esophagus, leading patients to visit the emergency room. Besides taking Dupixent, the options for EoE patients are making dietary changes and using corticosteroids to counteract the chronic inflammation.
The Phase 3 test of Tezspire in EoE enrolled 368 patients age 12 to 80. These participants were randomly assigned to receive a high or low dose of the study drug, or a placebo. The main goals were measuring the esophageal eosinophil count and assessing swallowing difficulty using a patient-reported questionnaire. Besides meeting these goals, the companies said Tezspire’s safety profile was generally consistent with the drug’s approved indications.
In a research note, William Blair analyst Matt Phipps said Tezspire’s preliminary results in the EoE study support a potential third indication for the drug, which was first approved in 2021 as a maintenance treatment for severe asthma and then for chronic rhinosinusitis with nasal polyps (CRSwNP) last year. EoE affects an estimated 470,000 people in the U.S., and its growing prevalence makes it an attractive market, Phipps said.
William Blair models global Tezspire sales of about $2.7 billion this year, growing to $3.3 billion in 2027. But Phipps noted that those figures reflect only the currently approved uses for the drug, so a regulatory nod in EoE would bring additional revenue growth. He added that Tezspire has shown greater efficacy than Dupixent in CRSwNP, which like EoE is also driven by type 2 inflammation. That offers positive readthrough for Tezspire in EoE. Other companies with antibodies in earlier stages of clinical development for EoE include First Tracks Biotherapeutics and Apogee Therapeutics, a biotech that AbbVie is acquiring for $11 billion.
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Tezspire was initially discovered by Amgen; AstraZeneca later signed on as a development partner. According to the terms of the collaboration agreement, the partners share in commercialization of Tezspire in the U.S. while AstraZeneca records sales of the product in the rest of the world. AstraZeneca also leads development of Tezspire for other indications. Besides the EoE study, a Phase 3 test is ongoing in chronic obstructive pulmonary disease.
“The positive results of the Phase 3 CROSSING trial reinforce our confidence in the differentiated mechanism of action of Tezspire, which has now demonstrated clinically meaningful efficacy in a third epithelial-driven inflammatory disease,” Sharon Barr, AstraZeneca executive vice president, biopharmaceuticals R&D, said in a prepared statement. “Epithelial science represents an important and rapidly evolving area in respiratory and immunology medicine, and we look forward to sharing these results at an upcoming medical meeting and with regulatory authorities as quickly as possible.”
Photo: Christopher Furlong, Getty Images