Amgen and AstraZeneca’s Tezspire has secured another Phase III win in a third epithelial-driven inflammatory disease, potentially paving the way for the drug to secure a new addition to its label. The drug, which has already been approved for severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), was tested in the CROSSING trial for its therapeutic potential in adult and adolescent patients with symptomatic and uncontrolled eosinophilic oesophagitis (EoE).
Phase III Trial Results
In the CROSSING trial, patients who received Tezspire found it significantly easier to swallow than those in the placebo group at week 24, meeting one of the trial’s co-primary endpoints. This effect on ease of swallowing was also sustained through to week 52. Additionally, Tezspire allowed significantly more patients to achieve histologic remission, meaning the drug also met its second co-primary endpoint.
According to the trial’s readout, Tezspire’s safety profile in EoE was similar to its approved indications. The partners will share the results with regulatory authorities and present detailed data from the study at an upcoming medical conference.
Tezspire’s Potential
Amgen’s executive vice president of R&D, AI and data, Jay Bradner, said: “In this Phase III trial, Tezspire improved both the underlying inflammation and the swallowing difficulties that can make EoE so disruptive for patients. That combination is important for patients and builds confidence in Tezspire as a potential new treatment for people struggling with EoE.”
Tezspire’s efficacy in EoE will be welcome news for partners Amgen and AstraZeneca, as they seek an expanded role for their blockbuster drug across several epithelial inflammatory disorders. Currently, the US Food and Drug Administration (FDA) has given Tezspire the regulatory greenlight as an add-on maintenance treatment in both severe asthma and inadequately controlled CRSwNP.
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The drug’s sales have been on an upward trajectory this year, with AstraZeneca reporting a revenue uptick. Now, with another indication potentially added to the mix, GlobalData analysts forecast peak sales of over $4bn for Tezspire.
Market Competition
However, it is currently unclear how Tezspire, if approved, will fare against competition from currently approved medicines in the EoE arena – including Sanofi and Regeneron’s Dupixent (dupilumab) and Takeda’s Eohilia (budesonide oral suspension).
With its unique mechanism of action as a thymic stromal lymphopoietin (TSLP) blocker, Tezspire may offer a new treatment option for patients with EoE.
For now, Amgen and AstraZeneca will wait for regulatory authorities to review the CROSSING trial’s results and determine Tezspire’s fate in the EoE market.
