AstraZeneca Plc AZN and Amgen Inc AMGN released topline data from the Phase 3 WAYPOINT trial of Tezspire (tezepelumab) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps])

The data showed that Tezspire demonstrated a statistically significant and clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo.

WAYPOINT is a randomized, double-blind trial that evaluated the efficacy and safety of Tezspire administered subcutaneously compared to placebo in adults with severe CRSwNP.

Participants in the trial were symptomatic despite treatment with standard of care (intranasal corticosteroids [INCS]).

Chronic rhinosinusitis with nasal polyps is a condition that can cause symptoms from sinus pain and nose stuffiness to loss of smell. Nasal polyps are growths in the nose or sinuses.

The safety profile and tolerability of Tezspire in this trial were consistent with the known profile of the medicine.

Full results will be shared with regulatory authorities and the scientific community at an upcoming medical meeting.

Tezspire is currently approved for severe asthma in the US, EU, Japan, and nearly 60 countries.

It is approved as a single-use pre-filled syringe and auto-injector for self-administration in the US and EU.

In May, the companies announced the results of the Phase 2a COURSE trial of Tezspire for severe chronic obstructive pulmonary disease (COPD) with a broad range of baseline blood eosinophil counts (BEC) irrespective of emphysema, chronic bronchitis, or smoking status. 

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.

Price Action: AMGN stock closed at $321.91 on Thursday, and AZN stock is up 0.11% at $64.76 during the premarket session at the last check on Friday.