Reprinted with the kind permission of Cort Johnson and HealthRising.
In February of last year, Health Rising announced an unusual event was going to take place: a small drug company named Cortene was going to trial a new drug for chronic fatigue syndrome (ME/CFS). Cortene’s trial was unique in a number of ways. For one, it involved ME/CFS – a disease which rarely receives drug trials – and it employed a drug (CT38) not currently being used to treat disease.
Cortene proposed the novel idea that excessive levels of a receptor called CRF2 found on certain neurons in the brain were producing an unrelenting and hyperactive stress response in ME/CFS. Cortene believed that this improperly activated stress response was, in turn, responsible for the numerous downstream immune, metabolic and other issues that studies indicate are present in ME/CFS.
After an extensive review of the ME/CFS research literature, Cortene concluded that every feature of ME/CFS – from the gender differences to the triggering events – could conceivably be explained by CRF2 upregulation. It then began to privately raise money for a trial to test its drug in ME/CFS.
The goal of the trial was to normalize the stress response in ME/CFS by causing the CRF2 receptor to leave the surface of neurons in the brain. Because it’s impossible to measure CRF2 levels inside a live brain, Cortene assessed the drug’s effectiveness – and its effects on CRF2 activity – using improvements in symptom levels over four weeks.
The small first-in-patient trial took place at the Bateman Horne Center between July 2018 and April 2019 and was designed to help Cortene get answers to 3 critical questions:
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- Is CT38 safe in ME/CFS patients? (It had been shown to be safe in animal studies and in a Phase 1 trial in healthy human subjects).
- Is CRF2 involved in the disease?
- Does a limited dose of CT38 bring about a lasting improvement in patients’ symptoms?
The answer to these questions from this small (14 patients) non-placebo-controlled trial was a qualified yes. The drug appears to be safe. The ME/CFS patients, interestingly, reacted to the drug at far lower doses than the healthy controls did in a past study. That unusual sensitivity potentially validates Cortene’s disease hypothesis and could indicate that CT38 may be getting at a core part of ME/CFS. The fact that the limited doses of CT38 given to the patients appeared to produce long term (4 weeks) symptom improvement also supports this novel treatment approach for ME/CFS.
Cortene’s next steps include filing its patent application, publishing the trial results and obtaining funding for a larger randomized, placebo-controlled Phase 2 trial which will provide much more information on the drug’s potential effects. That trial will attempt to confirm the initial trial results and determine the optimum dosing regimen; i.e. the optimum amount of drug to give patients and the optimum dose frequency.
Learn more about the Cortene Drug Trial for ME/CFS
- Cortene I: Cortene to Trial New Drug for Chronic Fatigue Syndrome (ME/CFS)
- Cortene II: A New Drug & A New Hypothesis For Chronic Fatigue Syndrome (ME/CFS)
- Cortene III – A New Drug for Chronic Fatigue Syndrome (ME/CFS): The Clinical Trial
- Cortene IV – The Cortene Chronic Fatigue Syndrome (ME/CFS) Drug Trial Begins
- Cortene’s website
About the Author: ProHealth is pleased to share information from Cort Johnson. Cort has had myalgic encephalomyelitis /chronic fatigue syndrome for over 30 years. The founder of Phoenix Rising and Health Rising, he has contributed hundreds of blogs on chronic fatigue syndrome, fibromyalgia and their allied disorders over the past 10 years. Find more of Cort’s and other bloggers’ work at Health Rising.