E-Therapeutics (LON:ETX) has defended the Phase IIb data that caused its stock to crater, with CEO Malcolm Young arguing that the trial has revealed a depression drug with "pretty much" the hoped-for profile. Young's stance is that while the Phase IIb found 20 mg and 70 mg of ETS6103 to be inferior to a decades-old generic, the safety and efficacy profile that has emerged across three doses and two Phase II trials suggests the drug can find a niche in the depression market.
|E-Therapeutics CEO Malcolm Young|
Oxford, U.K.-based e-Therapeutics generated the first tranche of data back in 2009. In that small Phase IIa trial, a 200-mg dose of ETS6103, an extended-release formulation of tramadol, showed comparable efficacy to amitriptyline, a tricyclic antidepressant.
E-Therapeutics, searching for evidence that its drug could also free patients from side effects associated with amitriptyline, set the doses at 20 mg and 70 mg in the experimental arms of its larger Phase IIb trial, which administered ETS6103 or amitriptyline to depression patients who had previously taken a selective serotonin reuptake inhibitor (SSRI) without success. Neither dose matched up to amitriptyline, causing the trial to miss its primary endpoint and shares in e-Therapeutics to trade down by as much as 30%.
On the upside, e-Therapeutics saw responses among patients in the 20-mg and 70-mg arms, including some remissions. The experimental arms also featured fewer adverse events and side-effect dropouts than the amitriptyline component of the trial. E-Therapeutics is now digging into the data, going down to the level of the experience of individual patients, in an attempt to build a case showing that ETS6103 has a place in the treatment of depression.
"We think there's an area after people have tried a SSRI and haven't responded where therapeutic options are weak at the moment. That's where we think we're sitting," Young told FierceBiotech. "The profile that we were looking for was response in those who failed a SSRI--including getting some into remission--a cleaner side effect profile than amitriptyline, protectable IP position and the opportunity to escalate back up to 200mg … if the patient is one of those that doesn't respond at 70mg. The bottom line is across those two trials that's what we've got."
Whether the data, which could equally be viewed as revealing a drug that underperforms amitriptyline at low doses and has a similar side-effect profile when the quantity is increased, are sufficient to land e-Therapeutics a partner remains to be seen. That is definitely the ambition, though.
"I don't think a company as small as e-Therapeutics is going to be running a Phase III," Young said.
E-Therapeutics is to spend the next month or two looking at data to figure out how to position ETS6103 commercially for talks with potential partners. The aim for e-Therapeutics is to do better at presenting the value of ETS6103 to partners than it did to investors, a group Young thinks would have responded better to the data if they were framed as the result of a dose-ranging trial.
"Calling it a non-inferiority trial might not have been the wisest thing that we've ever, ever done," he said.
- read FierceBiotech's take
- here's the statement