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AstraZeneca's Gefurulimab Trial Report: Promising Results for gMG Treatment

$AZN
Form 6-K
Filed on: 2025-07-24
Source
AstraZeneca's Gefurulimab Trial Report: Promising Results for gMG Treatment

Key Information Extracted from the Financial Report

Document Type: SEC Form 6-K Filing Date: July 24, 2025 Company: AstraZeneca PLC Commission File Number: 001-11960

Main Subject: Gefurulimab Nanobody Phase III Trial Results

  • Trial Name: PREVAIL (ALXN1720-MG-301)
  • Indication: Generalised Myasthenia Gravis (gMG)
  • Primary Endpoint: Improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score at week 26 compared to placebo.

Key Findings:

  1. Statistical Significance: Gefurulimab demonstrated statistically significant and clinically meaningful improvement in functional activities of daily living in adults with gMG.
  2. Disease Severity Reduction: The once-weekly self-administered subcutaneous C5 inhibitor showed significant reduction in disease severity at week 26.
  3. Trial Design: The trial was a global, randomised, double-blind, placebo-controlled study, enrolling 260 patients across 20 countries.
  4. Safety Profile: Gefurulimab was well-tolerated with a safety profile consistent with previous trials of C5 inhibitors, with no new safety signals observed.
  5. Future Steps: Data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

Quotes from Key Personnel:

  • Dr. Kelly Gwathmey: Highlighted the importance of early intervention and sustained disease control for gMG patients, noting the treatment's convenience.
  • Marc Dunoyer (CEO, Alexion): Emphasized the potential for gefurulimab to provide rapid and sustained disease control, reinforcing the established safety profile of C5 inhibition.

Background Information:

  • About gMG: A rare autoimmune disorder characterized by muscle weakness and loss of function, primarily affecting women under 40 and men over 60.
  • Mechanism of Action: Gefurulimab is a dual-binding nanobody that inhibits complement C5, aimed at reducing the overactive immune response.

Conclusion: The results from the PREVAIL trial are promising for the development of gefurulimab as a treatment option for gMG, highlighting its efficacy and safety for patients, and positioning AstraZeneca for potential market entry following regulatory review.