“We’ve been seeing trial fail after fail after fail.” Ezra Spier, a Long COVID patient-researcher, said that on Tuesday, September 15, after hearing early results from a drug trial he had helped advise. “Seeing something that provides demonstrated impact, I think is really exciting.”
The drug is bezisterim, and its developer, BioVie, shared the Phase 2 ADDRESS-LC results in a webinar. They have not been peer-reviewed. Still, The Sick Times reported that the study’s expert advisors called them among the most promising from any Long COVID trial so far. For families living with fatigue that never lifts, that matters.
What the trial found
The trial enrolled 203 people, who took the oral drug or a placebo for three months. It was funded for up to $13.1 million by the Department of Defense. Investigators built it as a proof-of-concept study, tracking 22 metrics instead of a single pre-set primary endpoint, and sorted participants by symptom: high fatigue, high post-exertional malaise (PEM), or high neurological symptoms. About four in five met the bar for high burden in at least one of those.
Across all participants, 21 of the 22 metrics trended toward improvement. None reached statistical significance in the full group, which investigators said may reflect how different people’s symptoms were at the start. In the subgroups, several did. Fatigue scores improved significantly among people with high fatigue, and cognitive test scores improved significantly among those with high neurological symptoms.
“The critical thing to recognize is that you need to have the symptom to begin with in order to improve,” said BioVie CEO Cuong Do.
BioVie says early results show the drug was safe. Michael Peluso, a Long COVID researcher at the University of California, San Francisco who advised the trial, called the safety profile “really excellent” and noted that people with Long COVID are often sensitive to drugs and already taking many. He said a few dozen Long COVID trials of other agents had produced nothing “as consistent and as compelling.”
What happens next
Bezisterim is a synthetic steroid derivative that crosses the blood-brain barrier. BioVie believes it reduces inflammation and improves insulin sensitivity, and it is also being tested for Parkinson’s and Alzheimer’s.
BioVie wants a larger Phase 3 trial to confirm the results, and Penelope Markham, who leads its Long COVID program, said it will pursue Breakthrough Therapy designation and accelerated FDA approval. The trial would aim to enroll people with the most severe illness, possibly with a decentralized arm so some could take part from home. Funding could come from another Defense Department grant, the National Institutes of Health’s RECOVER program, or investors.
Do has put the scale of the problem at about 17 million Americans with Long COVID, roughly 3 million of whom have had to leave or change jobs. Bezisterim remains an experimental drug. Anyone living with Long COVID should consult their doctor about treatment.
Sources
- BioVie CEO shares insights into long COVID trial – ICYMI
- Bezisterim may help with some Long COVID symptoms, drug’s developer reports in early trial results – The Sick Times
