Tezspire Shows Promise in Chronic Rhinosinusitis, Challenging Competitors

Amgen and AstraZeneca's Tezspire has demonstrated strong clinical efficacy in chronic rhinosinusitis with nasal polyps (CRSwNP), potentially positioning it as a leading therapy in the field. The phase 3 Waypoint study results, presented at the joint conference of the American Academy of Allergy, Asthma & Immunology and the World Allergy Organization, have sparked discussions about Tezspire's potential to become a best-in-disease treatment.

Impressive Clinical Data

Tezspire significantly improved both total nasal polyp score (NPS) and nasal congestion score (NCS) in CRSwNP patients compared to placebo after 52 weeks. The drug showed a placebo-adjusted average improvement of 2.07 points on the NPS scale (range 0-8) and 1.03 points on the NCS scale (range 0-3).

Dr. Joseph Han from Eastern Virginia Medical School, a co-primary investigator of the Waypoint trial, highlighted that Tezspire nearly eliminated the need for future surgery and corticosteroid use. The drug's safety profile remained consistent with previous studies, with serious adverse events occurring in 4.9% of Tezspire patients compared to 5.9% in the placebo group.

Competitive Landscape

Tezspire's efficacy numbers appear to surpass those of its main competitors, Sanofi and Regeneron's Dupixent and GSK's depemokimab. Dupixent, the first FDA-approved treatment for inadequately controlled CRSwNP, showed a 52-week placebo-adjusted difference of 1.8 on NPS and 0.9 on NCS in its phase 3 trials. GSK's depemokimab demonstrated a 52-week NPS difference of 0.7 points versus placebo in its Anchor-1 and Anchor-2 trials.

However, analysts from William Blair and Leerink Partners caution against direct comparisons due to differences in trial designs. The Leerink team maintained its $4.3 billion Tezspire sales projection for Amgen by 2030, compared to the consensus estimate of $3 billion.

Mechanism of Action and Market Potential

Tezspire, which blocks thymic stromal lymphopoietin (TSLP), offers a unique first-in-class mode of action. This differs from depemokimab, which targets IL-5, and Dupixent, which inhibits the IL-4/13 axis. Sharon Barr, AZ's head of biopharmaceuticals R&D, emphasized that Tezspire's mechanism of targeting TSLP at the top of the inflammatory cascade could potentially transform care for patients with epithelial-driven inflammatory diseases.

The CRSwNP market represents a significant opportunity, with Dupixent already achieving blockbuster annual sales in this indication alone. As the field evolves, several companies are pursuing long-acting anti-TSLP antibodies, including GSK's acquisition of Aiolos Bio and its candidate AIO-001, and Winward Bio's recent $200 million series A funding for developing a twice-yearly anti-TSLP antibody.