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.
Protego targets faster, deeper organ responses and fewer cardiovascular complications
CEO Brent J. Warner said studies in newly diagnosed patients with cardiac involvement show that rapid depletion of amyloidogenic light chains correlates closely with improved survival. PROT-001 acts directly on amyloidogenic lambda light chains to stabilize them and neutralize their toxicity. Protego says SHIELD-AL will test whether this approach can deliver deeper and faster organ responses and reduce cardiovascular complications beyond standard of care alone.
Current therapies leave light chain toxicity unaddressed in a 28,000-patient US population
AL amyloidosis affects more than 5,100 newly diagnosed patients annually and 28,000 US adults. Current treatments reduce light chain production with plasma cell-directed therapies and manage organ complications. Toxic light chains can directly impair cardiomyocyte function, while amyloid deposits disrupt heart structure. Kidneys are also affected.
Protego will present data from its completed Phase 1 study of PROT-001 in healthy volunteers at a medical meeting later this year.