PR Newswire Clinical TrialsOriginal article
Protego Announces FDA IND Clearance for Phase 2/3 Study of PROT-001 in AL Amyloidosis
RegulatoryPROT-001Positive
AI Analysis
Summary
Protego announced FDA IND clearance for SHIELD-AL, a Phase 2/3 pivotal study of oral light chain stabilizer PROT-001 in newly diagnosed lambda AL amyloidosis patients. The drug will be evaluated as an add-on to standard-of-care plasma cell-directed therapy.
Clinical Trial Data
Phase
Phase 2/3
Outcome Details
FDA cleared the IND for a Phase 2/3 study (SHIELD-AL) of PROT-001, an oral light chain stabilizer, as an add-on to standard-of-care plasma cell-directed therapy.
Importance:5/10
Sentiment:
0.50
IND clearancePhase 2/3AL amyloidosisoral therapylight chain stabilizerpivotal studyFDA
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Published by PR Newswire Clinical Trials on October 19, 2026 11:01 AM