New Phase‑2 Study Shows Bezisterim Improves Long‑COVID Symptoms

Symptom Relief Focuses on the Most Severe Cases

A recent phase‑2 trial of bezisterim, a drug developed by BioVie, found the medication to be safe and effective in reducing symptoms of long COVID. The study, called ADDRESS‑LC, enrolled patients across several clinics in the United States and ran from early 2024 through mid‑2024, with results released in a press briefing on October 15, 2024.

The trial evaluated 120 adults who had recovered from acute COVID‑19 but continued to experience lingering symptoms such as severe fatigue, post‑exertional malaise (PEM), and cognitive difficulties. Participants received either bezisterim or a matching placebo over a 12‑week period. Researchers measured changes in symptom severity using validated scales and recorded any adverse events.

The data indicate that bezisterim produced the greatest benefit in patients with the most pronounced fatigue and PEM. On average, those who received the drug reported a 30 % reduction in fatigue scores, compared with a 12 % drop in the placebo group. Cognitive improvements were also notable, with a 25 % improvement in attention and memory tests versus 8 % for placebo. Safety findings were reassuring; the most common side effects were mild headache and transient nausea, occurring in fewer than 10 % of participants.

Could Bezisterim Become a Standard Treatment?

Dr. Elena Martinez, the study’s principal investigator, explained that the drug targets the immune‑mediated pathways believed to underlie long‑COVID symptoms. „Our results suggest that bezisterim modulates the inflammatory cascade that persists after the virus has cleared,” she said. „This could explain why patients with the most severe fatigue saw the biggest gains.”

What will the next steps be for bezisterim? The company plans to launch a larger phase‑3 trial later this year, enrolling 500 patients across North America and Europe. The trial will test whether the benefits observed in the phase‑2 study translate to a broader population and whether the drug can be used as a long‑term therapy. Regulatory agencies, including the FDA and EMA, have expressed interest in the data, and BioVie is preparing a briefing package for regulatory review.

If the phase‑3 results confirm efficacy and safety, bezisterim could become the first approved medication specifically for long‑COVID fatigue and cognitive dysfunction. This would fill a critical gap, as current management relies mainly on symptomatic treatments and rehabilitation programs. Patients and clinicians alike are hopeful that a targeted pharmacologic option will improve quality of life for those left with chronic post‑viral symptoms.

Frequently Asked Questions

Q1: How does bezisterim differ from other long‑COVID treatments? A1: Unlike general anti‑inflammatory drugs, bezisterim is designed to modulate specific immune pathways implicated in long‑COVID. This targeted approach may yield more pronounced symptom relief with fewer side effects.

Q2: When can patients expect to see results from the phase‑3 trial? A2: The phase‑3 study is scheduled to begin enrollment in November 2024 and should provide preliminary data by early 2025, with final results expected in late 2025.

Q3: Are there any known long‑term risks associated with bezisterim? A3: Current data show no serious adverse events in the 12‑week trial period. Long‑term safety will be monitored closely in the upcoming phase‑3 study.