Oxford-based e-Therapeutics' most advanced drug flopped badly in a Phase IIb study for depression, beaten out on efficacy by an aging generic.
The biotech, which has boasted a more sophisticated understanding of the biocomplexity of diseases, tackled one of the toughest targets in the industry when it chose depression as a priority. The company's trial randomized a large group of patients who didn't respond to classic SSRIs into two arms for ETS6103 and a third group which received a tricyclic called amitriptyline.
Their drug--a controlled-release formulation of the painkiller tramadol--proved inferior to the 55-year-old generic in treating depression, with top-line results flunking the primary endpoint in the study after tracking remissions based on the Montgomery-Asberg Depression Rating Scale score. The setback pointed the share price (AIM: $ETX) down more than 30%, though the stock later shaved off some of the losses and was trading down 17% Monday afternoon on the London exchange.
E-Therapeutics, founded by Malcolm Young, a former professor at Newcastle University, is just the latest in a long lineup of companies to try a new strategy in combating depression and fail at it. Alkermes ($ALKS) recently attempted its own pivotal study using a new study design that randomized nonresponders in the initial placebo group only to concede failure just weeks ago.
E-Therapeutics, like Alkermes, isn't giving up on its drug just because it failed a study. The biotech says it was planning to license out the drug if it achieved positive results, and says that a better tolerance for the drug among patients indicates that it could yet have a role.
"The global antidepressant market is substantial and growing and there is an increasing need for effective and less toxic drugs," noted Steve Self, e-Therapeutics' development director. "ETS6103's profile may offer benefit to patients who have not successfully responded to an SSRI and it may have fewer side-effects and superior tolerance when compared to a tricyclic antidepressant. We will analyze the datasets further, particularly in relation to these apparent benefits, to identify what further development and potential out licensing steps should be taken."
- here's the release