Amgen-AstraZeneca Partnered Asthma Drug Shows Rapid And Sustained Effect In Chronic Rhinosinusitis

On Saturday, Amgen Inc AMGN and AstraZeneca Plc AMGN announced full results from the Phase 3, registrational WAYPOINT trial evaluating the efficacy and safety of tezepelumab in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP).

The company released topline data in November 2024.

The data demonstrated that Tezspire (tezepelumab-ekko) significantly reduced nasal polyp severity, the need for surgery, and systemic corticosteroid use in CRSwNP (nasal polyps) patients compared to placebo.

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Treatment with Tezspire significantly reduced nasal polyp severity: the Nasal Polyp Score (NPS) was -2.065, and the nasal congestion score was -1.028 at week 52 compared to placebo.

Improvements in NPS were observed as early as week four and nasal congestion as early as week two (the first post-treatment assessments, respectively) and were sustained through week 52.1

Statistically significant and clinically meaningful improvements were observed across all key secondary outcomes assessed in the overall trial population.

Tezspire significantly reduced the need for nasal polyp surgery by 98% and systemic corticosteroid treatment by 88% compared to placebo.

In patients with CRSwNP, Tezspire had a safety profile consistent with its approved severe asthma indication.

Tezspire is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

Tezspire is not indicated for the relief of acute bronchospasm or status asthmaticus.

In May, Amgen and AstraZeneca announced the results of the Phase 2a COURSE trial of Tezspire for severe chronic obstructive pulmonary disease.

The primary results showed that treatment with Tezspire led to a 17% numerical reduction in the annual rate of moderate or severe COPD exacerbations compared to placebo at week 52, which was not statistically significant.

The proof-of-concept study showed that, in patients with BEC ≥150 cells/µL, tezepelumab led to a nominally significant reduction of 37% in the rate of moderate or severe exacerbations compared to placebo.

Price Action: AMGN stock traded higher by 0.77% to $310.51 at the last check on Monday. AZN stock is up 0.10% to $76.29 at the last check Monday.

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