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

RegulatoryapprovedPROT-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. PROT-001 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 the Phase 2/3 SHIELD-AL study of PROT-001, an investigational oral light chain stabilizer, as an add-on to standard-of-care plasma cell-directed therapy.

Importance:5/10

Sentiment:

0.50

IND clearanceAL amyloidosisPhase 2/3oral light chain stabilizerFDApivotal studyrare disease

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

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