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Larazotide Confirms Safety and Efficacy in MIS-C, Prompts Long COVID Trial

The phase IIa trial demonstrated rapid gastrointestinal symptom resolution alongside complete spike antigen clearance by day 21 in children treated with larazotide.

Overview

  • In a 21-day, randomized, double-blind phase IIa trial involving 12 children with MIS-C, larazotide was well tolerated with no severe adverse events.
  • By days 7 and 14, 67% of participants receiving larazotide achieved at least 90% gastrointestinal symptom recovery compared with 20% receiving placebo.
  • All children treated with larazotide cleared detectable SARS-CoV-2 spike antigen by day 21, whereas some placebo recipients still had measurable antigen.
  • Larazotide acts as a zonulin receptor antagonist to strengthen intestinal barriers and prevent inflammatory spike proteins from leaking into the bloodstream.
  • Investigators have begun enrolling children and adults in a larger phase II trial to assess larazotide’s safety and effectiveness in treating long COVID symptoms.