Oct 19, 2026, 07:01 ET
– Clearance enables initiation of SHIELD-AL, a pivotal study in newly diagnosed patients with lambda AL amyloidosis
– Investigational oral light chain stabilizer to be evaluated as an add-on to standard-of-care plasma cell-directed therapy
SAN DIEGO, Oct. 19, 2026 /PRNewswire/ — Protego Biopharma, Inc., a clinical-stage biotechnology company developing small molecule therapies for protein misfolding diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PROT-001, enabling the company to initiate SHIELD-AL, its 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 for the treatment of AL amyloidosis.
“Improving organ outcomes, particularly cardiac, in AL amyloidosis remains an urgent need, and studies in newly diagnosed patients with cardiac involvement have demonstrated that rapid depletion of amyloidogenic light chains closely correlates to improvements in survival,” said Brent J. Warner, MBA, Chief Executive Officer of Protego Biopharma. “This highlights a therapeutic opportunity for PROT-001, which acts directly on amyloidogenic lambda light chains to stabilize and neutralize their toxicity, as a complement to plasma cell-directed therapies that reduce light chain production. SHIELD-AL will evaluate whether this complementary approach with PROT-001 can help patients achieve deeper and faster organ responses while reducing cardiovascular complications beyond standard of care alone.”
SHIELD-AL is a randomized, double-blind, placebo-controlled study of PROT-001 in newly diagnosed lambda AL amyloidosis patients, with Part A consisting of an initial safety and dose confirmation study and Part B a pivotal safety and efficacy study.
Protego will be sharing data from its completed Phase 1 study evaluating PROT-001 in healthy volunteers at a medical meeting later this year.
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