The ADDRESS-LC trial was a Phase 2, multicenter, randomized, double-blinded, placebo-controlled exploratory study that enrolled 203 patients to evaluate whether bezisterim could improve key neurological symptoms of Long COVID, including fatigue, brain fog, cognitive impairment and post-exertional malaise (PEM). The purpose of the Phase 2 trial was to identify the clinical endpoints where bezisterim may have the greatest effect and within which patient subpopulations. The ADDRESS-LC trial explored 22 different measures to assess clinical outcomes and a series of different biomarkers to identify pre-specified treatment-responsive patient subgroups.
The signal-finding trial showed that 21 out of 22 clinical endpoints showed numerical trends favoring bezisterim treatment in the overall trial population, though no endpoint achieved statistical significance.
In pre-specified subgroup analyses submitted to the FDA prior to data unblinding, patients with greater baseline burden on one or more symptoms (approximately 80% of trial participants) demonstrated statistically significant improvements on multiple clinically coherent endpoints with larger treatment effects.
Bezisterim’s safety and tolerability profile was similar to placebo.
