New late-stage data on AstraZeneca’s gefurulimab

AstraZeneca (LSE: AZN) on Thursday touted Phase III data regarding its investigational inhibitor gefurulimab meeting its primary endpoint in myasthenia gravis activities of daily living.

The Cambridge, UK-based pharma major said gefurulimab demonstrated improvement at week 26 compared to placebo, with a clinically meaningful improvement observed as early as week one, and sustained through week 26. Generalized myasthenia gravis is a rare autoimmune disorder characterised by loss of muscle function and severe muscle weakness.

Positive results from the global PREVAIL Phase III trial showed that gefurulimab met its primary endpoint, demonstrating a statistically-significant and clinically-meaningful improvement from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score compared to placebo in adults with anti-acetylcholine receptor (AChR) antibody-positive (Ab+) generalised myasthenia gravis (gMG) at week 26. PREVAIL also met all secondary endpoints, including change from baseline in Quantitative Myasthenia Gravis (QMG) total score at week four and week 26.