Under the trial protocol, patients are enrolled prior to first-line treatment so that this can be standardised: every patient will receive the SSRI citalopram. Those with significant depressive symptoms remaining after six weeks on citalopram will enter the randomised phase of the study, which compares two different doses of ETS6103 with amitriptyline, a widely available tricyclic antidepressant. Approximately 160 patients will be randomised.
The principal objective is to test whether the two ETS6103 regimens have antidepressant activity 'non-inferior' to that of amitriptyline. The primary measure of activity is the change in Montgomery-Åsberg Depression Rating Scale (MADRS) score between randomisation and the end of treatment eight weeks later. Safety and a variety of secondary efficacy variables will also be assessed. e-Therapeutics expects to report the results of the trial in the first half of 2015. If these are positive, the Company intends to seek a licensing deal for the drug.
Stephen Self, Development Director at e-Therapeutics, said: "A clear need exists for better treatments for patients who do not respond well to first-line anti-depressant therapies. We believe that ETS6103 has potential in this population and are working with an experienced group of clinicians to test this proposition in a randomised controlled trial."
Malcolm Young / Daniel Elger Tel: +44 (0) 7909 915 068 www.etherapeutics.co.uk
Panmure Gordon (UK) Limited
Fred Walsh / Grishma Patel / Duncan Monteith
Tel: +44 (0) 20 7886 2500 www.panmure.com
Melanie Toyne Sewell / Stefanie Bacher / Rebecca Caygill / Donia Al Saffar
Tel: +44 (0) 20 7457 2020
Email: e-therapeutics@collegehill.com
Ted Agne
Tel: (+1) 781 631 3117
Email: edagne@comstratgroup.com
ETS6103 is a controlled-release formulation of tramadol. An earlier small phase IIa study produced encouraging results when it compared ETS6103 with the established antidepressant amitriptyline in patients with major depressive disorder.
About e-Therapeutics
e-Therapeutics is an AIM-listed biotechnology company with a proprietary platform in network pharmacology, an innovative new approach to drug discovery based on advances in network science and chemical biology. The Company's discovery and development activity is focused in cancer and disorders of the nervous system.
e-Therapeutics is based at sites in Oxford and Newcastle, UK. For more information about the Company please visit www.etherapeutics.co.uk.
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