CT38 is a potent, short-lived, peptide agonist selective for CRFR2. It is comprised entirely of naturally-occurring amino acids.
It was tested in animals and in healthy humans in a Phase 1 clinical trial. These studies have defined the safety profile of CT38 in humans and show that CT38 only lasts a few hours in the body.
A recent Phase 1/2 clinical trial to Investigate CT38 in ME/CFS patients (InTiME) tested various doses to understand how Cortene’s novel treatment approach might work (registered on ClinicalTrials.gov). Preliminary data support the following statements:
- As predicted, CRFR2 appears to be upregulated in ME/CFS patients (relative to healthy human subjects).
- Side-effects were mostly minor and resolved without intervention.
- A short treatment (~10 hours) with CT38 resulted in symptom improvements that lasted at least 28 days (the monitoring period of the trial).
- In the most effective dosing group, symptom improvement was:
- substantial (average 26%);
- effective on all monitored symptoms;
- immediate (within 1-2 days of treatment);
- persistent (at least 28 days); and
- statistically significant (p=0.009).
- Symptom improvement was related to total dose, suggesting that increasing the total dose could reduce symptoms further.
Cortene’s hypothesis, treatment approach and clinical trial are described more thoroughly in our recent publication.