Protego Announces FDA IND Clearance for Phase 2/3 Study of PROT-001 in AL Amyloidosis

Trial StartPROT-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 oral light chain stabilizer PROT-001, enabling study initiation.

Importance:5/10

Sentiment:

0.50

IND clearancePhase 2/3AL amyloidosisSHIELD-ALoral light chain stabilizerpivotal studyFDArare diseaseSan Diego

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Published by PR Newswire Biotech on October 19, 2026 11:01 AM

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