Protego wins FDA clearance for Phase 2/3 trial of PROT-001 in AL amyloidosis

PUBT · 3d ago
Protego wins FDA clearance for Phase 2/3 trial of PROT-001 in AL amyloidosis
  • Protego Biopharma received FDA clearance to initiate SHIELD-AL, a pivotal Phase 2/3 study of PROT-001 in newly diagnosed lambda AL amyloidosis patients.
  • The randomized, placebo-controlled trial will evaluate the oral light chain stabilizer as an add-on to standard-of-care plasma cell-directed therapy.
  • An initial safety and dose-confirmation stage will precede pivotal safety and efficacy testing.


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