Curie Brief
Turn on cookies to sign in
Signing in saves your progress to your Curie account. We can only do that with cookies on — turn them on to continue.
News
A phase 2 trial of bezisterim found no significant results across all long COVID patients, but a pre-specified subgroup with more severe symptoms saw meaningful improvements in fatigue, post-exertional malaise, and cognition. The drug was well-tolerated, with fewer adverse events than placebo. BioVie says the findings support moving to a phase 3 confirmatory trial.
The phase 2 ADDRESS-LC trial of bezisterim (NE3107) didn't hit the mark across its full patient population — none of the 22 clinical outcome measures reached statistical significance in the intent-to-treat analysis. But 21 of 22 endpoints trended in bezisterim's favor, and pre-specified subgroup analyses told a more compelling story.
Among patients with more severe baseline fatigue, post-exertional malaise, or cognitive impairment — roughly 78% of the ~200-person trial — bezisterim showed statistically significant improvements across multiple symptom domains. Treatment effect sizes (Cohen's d) more than doubled in these subgroups compared to the overall population. Bezisterim is an oral, brain-penetrant insulin sensitizer that targets inflammatory pathways (ERK/NF-κB and TNF-α) without broad immunosuppression.
Key Takeaways:
Why it matters: No treatments are currently approved for long COVID's neurological symptoms. These results — described by BioVie as the first of their kind — could pave the way for a phase 3 trial targeting the patients most likely to benefit.
