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e-Therapeutics to take more time to assess mixed trial data

The side effects and tolerance profile of ETS6103 were found to be more benign than amitriptyline.
e-Therapeutics to take more time to assess mixed trial data
The firm will re-look at the results.


e-Therapeutics (LON:ETX) said it will spend more time analysing the mixed data from the phase IIb study of its most advanced drug candidate, ETS6103.

It was being developed as second-line treatment for people with depressive disorders who don’t satisfactorily respond to, or relapse using, the current go-to medication.

The side effects and tolerance profile of ETS6103 were found to be more benign than amitriptyline, but the trial was also designed as what’s called a non-inferiority study.

In other words the e-Therapeutics treatment had to perform as well as, if not better than, amitriptyline when it came to treating depression.

That non-inferiority hurdle wasn’t cleared. “Responses were, however, observed in all three experimental arms of the study,” e-Therapeutics told investors.

“In the two ETS6103 arms, some patients went into remission and there were fewer adverse event and side effect dropouts in the ETS6103 groups compared to amitriptyline.”

While the most advanced of its pipeline, ETS6103 is not the major value generator for e-Therapeutics.

Its flagship drug candidate, ETS2101, has moved into phase Ib clinical trials treating hepatocellular carcinoma and pancreatic cancer.

Its research platform, which uses to network pharmacology to identify potential treatments, generated multiple live projects last year.

Responding to today’s news, Steve Self, the firm’s development director, said there may still be a role for the ETS6103.

"The global antidepressant market is substantial and growing and there is an increasing need for effective and less toxic drugs,” he said.

“ETS6103's profile may offer benefit to patients who have not successfully responded to a selective serotonin reuptake inhibitor and it may have fewer side-effects and superior tolerance when compared to a tricyclic antidepressant.

“We will analyse the data-sets further, particularly in relation to these apparent benefits, to identify what further development and potential out licensing steps should be taken."

The shares, off 16% in afternoon trade, pared losses seen earlier in the session as analysts and investors took a closer at the release.
In an interview with Proactive, e-Therapeutics chief executive Malcolm Young gave greater context to the release as he said the drug had a “cleaner profile” than amitriptyline.

He added he was “pleased” with the results from the two most recent studies – the phase IIa and IIb.

And he explained: “It’s much less prone to giving side effects and tolerance problems to patients.

“So, we have hit that sweet spot of that lower dose, which is a little bit off the efficacy of amitriptyline in these patients, but still effective, and in the higher dose you’d see it right alongside amitriptyline.”


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e-Therapeutics plc Timeline

September 20 2016

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