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e-Therapeutics (ETX.L) - results of its pilot Phase IIa in Major Depressive Disorder
ETX.L
Comment by Objective Capital , Jan 14, 2009
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e-Therapeutics has announced the full results of its pilot Phase IIa trial in MDD using ETS6103.
Patients with a modal depression score (using the standard Hamilton D depression rating scale in HDRS) of 23, reflecting severe disease, were randomly treated with either ETS6103 or amitryptiline, a commonly used and highly effective triclyclic anti-depressant.
Over the 12-week test period, both groups showed a statistically significant reduction in HDRS reaching a score of 0 by the sixth visit (bi-monthly visits). Efficacy was comparable between the two groups but there were significant differences between the two groups:
Objective's view:
As indicated in our initiation report of December 2009, we believed that ETS6103 would be the first clear proof of principle of e-Therapeutics’ brand of 'predictive' drug discovery, enabling the identification of compounds with full clinical monographs (a full set of safety/tolerance data in humans being the prerequisite) that can be repositioned and re-purposed for a different indication than the one that they were originally tested for.
In this case, the search for this compound started from the premise that pain and depression are linked and co-morbid conditions and that pain treatments in and of themselves could be highly effective treatments for depression; and such was born ETS6103.
This trial, originally designed as a pilot trial in 40 patients equally split between the two randomly assigned treatment arms, showed such astonishing efficacy in the initial patients treated that for both cost and ethical reasons, it was halted mid-way.
Tricyclic antidepressants are very nasty drugs but are highly efficacious and within the context of MDD, there is often no choice but to use them. SSRI's are much cleaner drugs and are widely used but have limited efficacy and fail to work in a significant number of patients. A drug with the efficacy of the former and the 'cleaner' side-effect of the latter could become a very popular alternative to current treatment modalities.
While this is not the final 'proof of the pudding' for this complex system analytical approach, it does open the door to very useful applications of this approach and potentially lucrative therapeutic modalities. The holy grail remains truly 'predictive' discovery of safe and efficacious drugs where the original mode of action is irrelevant; here, only chemical structure and its interactions with systems count. In this regard, the work that e-Therapeutics is doing with ETS2101 in cancer will be very telling.
The bottom line is that e-Therapeutics now has a drug that has been shown to be highly efficacious in severe MDD with an efficacy that is comparable to the most efficacious drug in this class but appears to have a more benign side-effect profile and, most importantly, a faster onset of action. ETS6103 is based on a generic pain drug but e-Therapeutics believes that its mechanism of action/application patent application will be equivalent to a composition of matter patent affording it maximum protection. From a business development point of view, it is likely that the profile displayed by this drug will provide e-Therapeutics with multiple opportunities for outlicensing while also giving its approach enhanced credibility with major and minor pharma.
