AstraZeneca and Amgen’s Tezspire Shows Efficacy in Phase 3 Trial for Chronic Rhinosinusitis with Nasal Polyps, Despite Regulatory Risk Concerns
Efficacy in Phase 3 Trial:
Tezspire (tezepelumab) demonstrated statistically significant and clinically meaningful reductions in nasal polyp size and nasal congestion compared to placebo in the Phase 3 WAYPOINT trial for patients with chronic rhinosinusitis with nasal polyps (CRSwNP)123.
Regulatory Risk:
Analyst Matt Phipps from William Blair noted that there could be regulatory risk for Tezspire in CRSwNP, as the WAYPOINT study is the only trial evaluating Tezspire specifically for this indication, unlike Dupixent (dupilumab) which had two pivotal studies for its approval4.
Mechanism of Action:
Tezspire targets and inhibits thymic stromal lymphopoietin (TSLP), a cytokine involved in initiating and maintaining allergic, eosinophilic, and other types of inflammation, which is common in asthma and CRSwNP123.
Current Approval:
Tezspire is currently approved for the treatment of severe asthma in the US, EU, and more than 50 countries23.
Future Development:
Tezspire is also in development for other potential indications, including chronic obstructive pulmonary disease (COPD) and eosinophilic esophagitis (EoE)23.
Collaboration:
AstraZeneca and Amgen will share costs and profits equally for Tezspire, with AstraZeneca leading development and Amgen leading manufacturing23.
Sources:
1. https://pmlive.com/pharma_news/astrazeneca-amgens-tezspire-shows-promise-in-phase-3-crswnp-trial/
2. https://www.prnewswire.com/news-releases/tezspire-met-both-co-primary-endpoints-in-phase-3-trial-for-chronic-rhinosinusitis-with-nasal-polyps-302299720.html
3. https://www.amgen.com/newsroom/press-releases/2024/11/tezspire-met-both-co-primary-endpoints-in-phase-3-trial-for-chronic-rhinosinusitis-with-nasal-polyps
4. https://www.biospace.com/drug-development/astrazeneca-amgen-claim-late-stage-win-in-chronic-rhinosinusitis-but-analyst-flags-regulatory-risk