In 2018 the Food and Drug Administration approved a physician-sponsored Investigational New Drug (IND) Application, to investigate the safety, tolerability and efficacy of CT38 in the treatment of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
Dr. Bateman was the Principal Investigator for this pilot phase 1/2 open-label clinical trial that was called InTiME – Investigate CT38 in the Treatment of ME/CFS. It was a small clinical trial that enrolled ME/CFS patients and everyone received the drug (there was no placebo in this trial). The trial was designed to investigate the safety and efficacy of CT38 and whether the drug was effective in improving physical function and reducing symptoms in ME/CFS patients. CT38 is a proprietary 40-mer peptide, consisting of naturally-occurring amino acids and was previously shown to be safe in a Phase 1 trial in healthy humans. The drug was provided to the Bateman Horne Center by Cortene Inc., who funded the trial and own the intellectual property rights to CT38 and its potential use in ME/CFS.
The trial used 3 subcutaneous infusions of CT38, at one of 4 dose-levels (no placebo), and compared patient-reported symptoms during 4-week periods pre- and post-treatment. There were 14 ME/CFS patients receiving the drug with the last patient enrolled in January 2019 and data collection completed for all participants by April 2019.
After extensive data analysis, the results of InTiME have been published in Frontiers in Systems Neuroscience and the paper is titled, “Acute corticotropin-releasing factor receptor type 2 agonism results in sustained symptom improvement in myalgic encephalomyelitis /chronic fatigue syndrome.” It was found that CT38 treatment was safe, generally well-tolerated, and associated with significant reduction in ME/CFS symptoms. Cortene is currently seeking investments to fund a larger trial in people with ME/CFS and Long COVID.
Clinical trials for ME/CFS are a rare event so we are excited to be able to share the promising results from the InTiME trial with you. BHC is leading the way for clinical trials for ME/CFS, FM, and Long COVID because of our unique center of excellence model and our highly engaged patient partners. We look forward to providing further information on the next phase of this and other trials.
We thank you for your continued support as we press forward in our vision to create a world where patients with ME/CFS, FM, and post-viral illnesses are readily diagnosed, effectively treated, and widely met with empathy and understanding. Please consider making a donation to BHC a 501 (c)3 nonprofit organization today.
Read Dr. Bateman’s September 9th blog post, Dr. Bateman On Cortene and CT38.