CT38 is a potent, short-lived, peptide agonist selective for CRF2. 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, CRF2 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.