Sanofi’s new AAT therapy shows promise, posing risk to Grifols

Published 22/10/2025, 13:18
© Reuters.

Investing.com -- Shares of Grifols fell 3.5% following news that Sanofi’s experimental therapy for Alpha-1 antitrypsin deficiency demonstrated positive results in Phase II clinical trials.

Sanofi’s recombinant AAT therapy, efdoralprin alfa (formerly INBRX-101), met all primary and secondary endpoints in its Phase II study. The treatment showed superiority to plasma-derived therapy and achieved normal functional AAT levels with less frequent dosing requirements of every 3-4 weeks.

While Sanofi’s study focused on measuring biochemical restoration through functional AAT levels, Grifols is taking a different approach with its SPARTA Phase III trial. The SPARTA study concentrates on clinical efficacy by measuring lung-tissue preservation via CT scans, which aligns with European Medicines Agency requirements.

Grifols is also working to enable bi-weekly dosing for its plasma-derived therapy, with a subcutaneous version in development to improve patient convenience.

The competitive threat from Sanofi’s new therapy represents a meaningful risk for Grifols, as Alpha-1 treatments account for over 10% of the company’s sales, estimated at more than €700 million, with over 70% of that exposure in the United States. Increased uptake of efdoralprin could potentially pressure both volumes and margins for Grifols’ existing treatments.

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