PARIS (dpa-AFX) - Sanofi (SNY, SNYNF, SAN.PA) announced positive topline results from the global Phase 2 ElevAATe study evaluating efdoralprin alfa (SAR447537, formerly INBRX-101) in adults with alpha-1 antitrypsin deficiency (AATD) emphysema. The investigational recombinant human AAT-Fc fusion protein met all primary and key secondary endpoints when administered every three weeks (Q3W) or four weeks (Q4W).
Efdoralprin alfa demonstrated a statistically significant greater mean increase in functional AAT (fAAT) levels within the normal range, as measured by trough concentrations at steady state, compared to weekly plasma-derived augmentation therapy at week 32 (p<0.0001). Key secondary endpoints were also met, including superior mean fAAT average concentration and a higher percentage of days above the lower limit of the normal range for both dosing regimens.
The therapy was well tolerated, with an adverse event profile comparable to plasma-derived therapy. Additional safety data will be collected in the ongoing ElevAATe OLE Phase 2 extension study.
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