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Recent topline results from a Phase 2 clinical trial suggest that bezisterim, an investigational drug, may help improve fatigue, post-exertional malaise (PEM), and cognitive impairment in people with Long COVID who have greater baseline burden of these symptoms.
BioVie had a press release with topline results from its ADDRESS-LC trial, a randomized, double-blind, placebo-controlled study involving 203 participants with Long COVID. Researchers evaluated bezisterim, an oral medication believed to reduce inflammation and improve insulin sensitivity, against placebo.
While the study did not find statistically significant improvements across the overall study population, 21 of 22 clinical endpoints numerically favored bezisterim. More promising results emerged in pre-specified subgroups of participants with higher baseline symptom severity.
Participants with more severe fatigue showed statistically significant improvements across five clinical measures, including three fatigue-specific endpoints. Those with high baseline PEM experienced improvements in PEM, fatigue, and objective cognitive function, while participants with substantial objective cognitive impairment showed statistically significant improvements across four objective cognitive measures.
Bezisterim was also generally well tolerated, with a safety profile similar to placebo. Adverse events were reported in 41.6% of participants receiving bezisterim compared with 55.9% receiving placebo.
These findings are encouraging, however, the subgroup results remain exploratory and require confirmation in larger trials. BioVie has announced plans to advance bezisterim into a Phase 3 trial to further evaluate its effectiveness and identify which patients may benefit most.
Read the full announcement: BioVie Phase 2 ADDRESS-LC Trial, September 15, 2026.
investors.bioviepharma.com/n…
ALT RECENT CLINICAL TRIAL UPDATE Bezisterim benefits Long COVID patients with fatigue, PEM, and cognitive impairment Image of a woman with a blurred face like she is dizzy
ALT STATEMENT FROM BIOVIE’S PRESIDENT AND CEO “To our knowledge, this is the first time a drug candidate has shown the ability to help patients improve across these persistent Long COVID symptoms. Thus, bezisterim may have the potential to become the first therapy for the neurological symptoms of Long COVID, if confirmed in our future Phase 3 trial.” — Cuong Do, President and CEO, BioVie
ALT RTHM’s TAKE “This is an exciting development in the clinical trial space for Long COVID. The possibility that this drug may help with some of the most difficult-to-treat symptoms could be transformative for many patients. I’m glad to see the company announce they are planning a Phase 3 trial to confirm their findings in this subgroup, and I will be following along closely.” — Jennifer Curtin, MD, RTHM Co-Founder
Managing post-exertional malaise (PEM) goes beyond pacing alone.
In this clip, Dr. David Putrino, Dr. Lucinda Bateman, and Dr. Jennifer Curtin share emerging approaches to reducing physical and cognitive PEM, including treatments targeting metabolic dysfunction and options such as low-dose rapamycin, metformin, oxaloacetate, CoQ10, dextromethorphan, low-dose naltrexone (LDN), NAD+, high-dose B1, and IV saline.
While some patients report improvements, responses vary, and research is still evolving. Identifying which treatments may help specific patients remains an important part of developing more personalized PEM management strategies.
Have you found any medications or supplements that help manage your PEM? Share in the comments.
Watch the full How to Manage and Treat Post-Exertional Malaise (PEM) webinar featuring Dr. Putrino, Dr. Bateman, Dr. Curtin, and moderator Charlie McCone.
Watch the full webinar here: na2.hubs.ly/H08vRL-0
Always consult with your healthcare provider before starting any new supplement, over-the-counter medication, or treatment. Individual risks, potential interactions, and appropriate dosing should be discussed with and monitored by your clinician.
Patient-Led Research Collaborative (@patientled) and RTHM Clinic recently released the Long COVID Treatment Guide to support more informed conversations between patients and their clinicians.
The guide covers over 30 different treatments. Today, we’re highlighting hyperbaric oxygen therapy (HBOT), which may be especially relevant for people with Long COVID experiencing cognitive impairment, fatigue, sleep issues, neuropsychiatric symptoms, or pain.
In a randomized, double-blind, placebo-controlled trial of 73 people with Long COVID, 40 HBOT sessions led to significant improvements in attention, sleep quality, pain, and energy levels that persisted even one year after treatment. Echocardiogram assessment in the same group also showed a meaningful reduction in global longitudinal cardiac strain.
A separate 10-patient study reported statistically significant improvements in fatigue and cognitive function after 10 HBOT sessions over 12 days. However, an interim safety analysis from an ongoing Karolinska Institute trial found that nearly half of participants experienced cough or chest discomfort during treatment, though it remains unclear whether those symptoms were related to HBOT or underlying Long COVID.
In the Harvard/Stanford/OMF TREATME study, 38% of people with Long COVID who tried HBOT reported moderate to much better symptom improvement, though the Long COVID sample was small at 13 participants. Among people with ME/CFS, 25% reported moderate to much better improvement.
HBOT should be discussed with a qualified clinician to determine whether it is appropriate for an individual case. The guide also notes that medical-grade HBOT can be expensive and time and energy consuming, and that claustrophobia can make treatment challenging.
Download the guide here: rthm.com/resources/blogs/lon…
ALT Title slide for Hyperbaric Oxygen Therapy (HBOT) as a treatment option in the Long COVID Treatment Guide.
COVID-19 continues to circulate across the United States with wastewater activity levels and trends varying meaningfully by location. Some states in the South, West, and Northeast report high or very high activity. CDC estimates released October 9 show that infections may be growing in some states, while trends are stable or declining in others.
The best time to make a COVID plan is before you need one.
Clinical research has found that starting metformin early during a COVID-19 infection was associated with a 41% lower risk of developing Long COVID.
RTHM offers medication assessments to help determine whether metformin may be appropriate for you to take if you get COVID-19, with access to the same dosing studied in the clinical trial. You can get the medication to have on hand before you need it or if you already have COVID-19.
Learn more here: rthm.com/medications
#COVID19 #LongCOVID #MECFS #POTS #MCAS #EDS #COVIDIsNotOver
ALT Metformin shown to reduce the risk of Long COVID by 41% in a major clinical trial with early treatment.
Have you tried low-dose naltrexone (LDN), pyridostigmine, or ivabradine for your PEM symptoms? Share your experience in the comments.
Post-exertional malaise (PEM) is more than feeling tired after activity. It’s a worsening of symptoms that can follow physical, cognitive, emotional, or even sensory exertion—and the crash may not hit until hours or even days later.
For people with ME/CFS and Long COVID, PEM can make it incredibly difficult to predict what the body will tolerate from one day to the next. Something as routine as showering, socializing, running errands, doing household tasks, or being in a stimulating environment can sometimes trigger a crash.
While there is currently no FDA-approved treatment for PEM, certain off-label medications may help address symptoms or underlying factors that contribute to crashes. Low-dose naltrexone (LDN), pyridostigmine, and ivabradine are three options supported by emerging research and used in clinical care for some patients.
Finding the right approach can take time, and treatment should be individualized based on your symptoms, health history, and other conditions. Swipe through to learn more about these three medications and the research behind them.
You can explore potential treatments like LDN, pyridostigmine, and ivabradine through RTHM, or create a free account on our HIPAA-compliant platform for treatment suggestions personalized to your health history.
Click here to get started: rthm.com/medications
#PEM #POTS #MECFS #LongCOVID #ChronicIllness #pwLC #pwME
ALT Title slide showing '3 Meds for PEM' discussing treatment options for Post-Exertional Malaise.
ALT Ivabradine helps reduce POTS symptoms linked to PEM by lowering excessive heart rate during activity and rest.
