FDA Clears Protego's PROT-001 IND for Pivotal AL Amyloidosis Study
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San Diego – October 19, 2026 -- The U.S. Food and Drug Administration has cleared Protego Biopharma's Investigational New Drug application for PROT-001, allowing the company to start SHIELD-AL, a global pivotal Phase 2/3 study in newly diagnosed light chain (AL) amyloidosis patients.
PROT-001 is an oral, investigational, first-in-class lambda light chain stabilizer. Protego will test it as an add-on to standard-of-care plasma cell-directed therapy, which reduces light chain production.
SHIELD-AL combines safety confirmation and pivotal efficacy testing in one randomized trial
The study is randomized, double-blind and placebo-controlled, and enrolls newly diagnosed patients with lambda AL amyloidosis. Part A is an initial safety and dose confirmation study. Part B is the pivotal safety and efficacy study.