Clinical Development Pipeline
e-Therapeutics has two drugs in clinical development. These are ETS2101 (glioma and other cancers; phase I) and ETS6103 (major depressive disorder, phase II).
ETS2101 (dexanabinol) is a synthetic cannabinoid previously studied in trauma patients. Application of network pharmacology by e-Therapeutics suggested that the drug has potential in cancer. Two phase I cancer studies are ongoing: one is enrolling patients with a variety of solid tumours at three centres in the UK (Newcastle, Leeds and Glasgow) while the other is an investigator-initiated trial in patients with primary or secondary brain cancer led by Professor Santosh Kesari at the UC San Diego Moores Cancer Center in La Jolla, California. Both trials have a dose-escalating design in which successive cohorts of patients receive increasing doses of ETS2101, with the aim of establishing an appropriate dose for phase II development, assessing safety and tolerability, and identifying any initial signs of anti-cancer activity. Interim findings from the two trials were reported during 2013. In early January we announced that the brain cancer phase I study had completed five dose-escalation steps without recording any serious drug-related side effects and would therefore continue into 2014, with further patients being enrolled at higher dose levels. Updates will be provided in due course and detailed findings from the trial will be submitted to a medical meeting when all patients have completed treatment. The solid tumour phase I study is due to report key findings on safety and dosing during Q1 2014.
Details of trial protocols: clinicaltrials.gov
UCSD press release about the brain cancer study
Cancer Research UK press release about the UK phase I trial
ETS6103 is in development for major depressive disorder. The drug has already produced encouraging data in a small phase IIa study in which it was compared with the tricyclic antidepressant amitriptyline. In October 2013 we started a phase IIb trial, which compares two doses of ETS6103 with amitryptiline in patients who have failed treatment with an SSRI (selective serotonin reuptake inhibitor). The phase IIb trial is expected to report data in H1 2015.
You can find more information about trials of our drug candidates at www.clinicaltrials.gov.