Open [USA] A Double-blind, Randomized Study to Evaluate the Efficacy and Safety of Bezisterim (NE3107) in Adults With Long COVID [ADDRESS-LC]

forestglip

forestglip

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A Double-blind, Randomized Study to Evaluate the Efficacy and Safety of Bezisterim (NE3107) in Adults With Long COVID

Brief Summary
Long COVID is a condition where debilitating symptoms can persist for months after a COVID-19 infection.This study aims to evaluate the effects of NE3107 on several neurological symptoms reported in people with Long COVID including difficulty concentrating or remembering things ("brain fog") and fatigue.

Researchers will compare NE3107 to a placebo (a look-alike substance that contains no drug) to see if NE3107 works to treat neurocognitive and fatigue symptoms of long COVID.

Participants will:
  • Take NE3107 or a placebo twice daily for 84 days
  • Visit the clinic 5 times for checkups and tests and have a follow up phone call
Summary from ADDRESS-LC website
The trial drug Bezisterim (NE3107), is a new investigational drug that may help reduce certain kinds of inflammation present in Long COVID that cause impaired cognition and fatigue. Bezisterim may work by blocking production of substances that cause inflammation through toll-like receptors (TLR) pathways known to cause issues in Long COVID.

Currently bezisterim is also in clinical development for Alzheimer’s and Parkinson’s diseases, two neurodegenerative diseases where inflammation causes neurologic symptoms and cognitive decline. This trial is testing whether bezisterim can improve cognitive function or brain fog and fatigue in individuals with Long COVID.

Locations
  • San Francisco, California
  • Aurora, Colorado
  • Jacksonville, Florida
  • Columbus, Georgia
  • Chicago, Illinois
  • Silver Spring, Maryland
  • Farmington Hills, Michigan
  • Cleveland, Ohio
  • Dallas, Texas
  • San Antonio, Texas
  • Morgantown, West Virginia

Eligibility Criteria

Inclusion Criteria:​
  • 18 years to 64 years of age
  • diagnosed with Long COVID with symptoms of fatigue and brain fog for at least 3 months
  • agree to use birth control measures
  • provide voluntary consent
  • willing to allow blood collection
  • pass all screening tests and procedures
Exclusion Criteria:​
  • has received a COVID-19 vaccination within 30 days
  • previous admission to the intensive care unit for COVID-19
  • medical history of major mental or physical illness prior to COVID-19 infection
Intervention
  • One 20 mg capsule containing NE3107 taken by mouth twice daily (BID)
  • One 20 mg capsule containing placebo taken by mouth twice daily (BID)

Outcome
Change in performance on the Cogstate Cognition battery

Sponsor
BioVie, Inc.

Links
 
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So this reports in like 6 months! I'd forgotten about it tbh, and how fast they're moving.
forestglip said:
Bezisterim may work by blocking production of substances that cause inflammation through toll-like receptors (TLR) pathways known to cause issues in Long COVID.
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So it works on TLR pathways, not clear which from this - could be interesting to know if this has an effect.
 
V.R.T. said:
So it works on TLR pathways, not clear which from this - could be interesting to know if this has an effect.
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I was interested in what this drug’s mechanism was based on this tagline and color me surprised to find out it’s just synthetic androstenediol. That’s an intermediate steroid hormone in estrogen/testosterone synthesis.

I guess all steroid hormones do have immunomodulatory properties but it’s just weird to focus exclusively on that and not mention what the drug is—like marketing a new progesterone analogue as an antianxiety treatment because some studies have linked it to GABA signaling and never mentioning that it’s, you know, progesterone. The cynical part of me has to wonder if the framing here is a result of focus group testing
 
I guess the rationale makes sense—if you’re looking for something that crosses the blood brain barrier and has a chance of affecting immune signaling in the brain, mimicking an endogenous steroid is a good bet. The question is just why androstenediol—if it’s because that form has been found to have more “potent effects” compared to other intermediate metabolites, it seems likely that orally supplemented androstenediol is going to be very quickly converted into other forms in that pathway.

And the side effects are going to be the side effects of hormone replacement therapy, so tolerability is going to be a major issue. Giving it to only older people with Alzheimer’s is going to be a very different scenario from giving it to people across a wide age range.
 
V.R.T. said:
What? That's crazy! As if they can get away with never saying its that...
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I mean at this phase it matters most for informed consent, and if they’re doing an appropriately thorough job warning about potential adverse effects it theoretically doesn’t matter whether they mention that it’s a similar profile to other steroid hormones therapies. It might even be a strategic choice for blinding, since some changes like “increased sex drive” might not be considered an adverse effect per se but it’s something people would definitely associate with a steroid hormone.

But my guess is that there’s probably just financial interest in avoiding people’s associations and aversions to the concept of steroid hormones if this drug makes it to market. And framing themselves as a company that makes “novel neuroimmunomodulatory compounds”probably has more investor appeal than “we made another pre-testosterone”
 
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