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AstraZeneca's RESOLUTE Trial Report: Fasenra for COPD Shows Promise but No Stat Significance

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Form 6-K
Filed on: 2025-09-17
Source
AstraZeneca's RESOLUTE Trial Report: Fasenra for COPD Shows Promise but No Stat Significance

Key Information Extracted from AstraZeneca's 6-K Filing

Document Overview

  • Type: 6-K
  • Date: September 17, 2025
  • Company: AstraZeneca PLC
  • Commission File Number: 001-11960

Trial Update: RESOLUTE Phase III Trial

  • Treatment Under Study: Fasenra (benralizumab)
  • Indication: Chronic Obstructive Pulmonary Disease (COPD)

Key Findings

  1. Primary Endpoint: The trial did not achieve statistical significance in the primary endpoint, which was the annualized rate of moderate or severe COPD exacerbations.
  2. Numerical Improvement: Although the treatment exhibited a numerical improvement, it was not statistically significant.
  3. Safety Profile: The safety and tolerability of Fasenra in the trial were consistent with its established profile.
  4. Next Steps: AstraZeneca plans to analyze the full data set from the RESOLUTE trial to gain further insights, which will be communicated to the scientific community.

Background on Fasenra

  • Current Approvals: Fasenra is approved as an add-on maintenance treatment for severe eosinophilic asthma (SEA) in over 80 countries, including major markets like the US, EU, Japan, and China. It is also approved for treating eosinophilic granulomatosis with polyangiitis (EGPA) in over 60 countries and is under review for hypereosinophilic syndrome (HES).
  • Patient Population: Over 150,000 patients globally are currently on Fasenra.

Trial Design

  • Trial Type: Randomized, double-blind, placebo-controlled Phase III trial.
  • Population: 689 participants with moderate to very severe COPD and a history of frequent exacerbations.
  • Treatment Regimen: Participants received either placebo or Fasenra (100 mg every four weeks for the first three doses, then every eight weeks).

Key Secondary Endpoints

  • Included annualized rate of severe exacerbations, change in SGRQ total score, and change in pre-dose FEV1 at Week 56.

Additional Context

  • COPD is a major global health issue, affecting approximately 391 million people worldwide, and is a leading cause of morbidity and mortality.
  • AstraZeneca emphasizes its commitment to addressing COPD and other respiratory diseases through ongoing research and development efforts.

Summary

The RESOLUTE Phase III trial for Fasenra demonstrated numerical improvements in treating COPD but did not meet the statistical significance for its primary endpoint. AstraZeneca will continue to analyze the data and remains focused on developing treatments for chronic respiratory diseases.