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.
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