Enanta fails to convince with Nash win

Sometimes success just does not look like success. Enanta Pharmaceuticals’ statistical win in lowering liver inflammation markers with its Nash project EDP-305 was not enough to put clear blue water between it and the competition. After 12 weeks on the highest 2.5mg dose of EDP-305 patients in the phase IIa Argon 1 trial saw their ALT levels fall by 12mg on a placebo-adjusted basis, similar to that seen with a low dose of Ocaliva. Strong data would have helped to convince investors that EDP-305 could stand a chance against Ocaliva, which is set to reap the advantages of being first to market if it is approved early next year. More concerning for EDP-305 were the red flags around tolerability. Enanta had previously stated that the way EDP-305 binds to FXR should avoid the pruritus that has blighted Ocaliva, but this does not seem to be the case: 21% of EDP-305 patients discontinued treatment owing to the side effect. These results do not say best in class, and if any of other next-generation FXR agonists nipping at Enanta’s heels can crack the pruritus issue EDP-305 will be firmly consigned to the also-rans. 

A cross-trial comparison: EDP-305 and Ocaliva
  EDP-305: Argon-1 Ocaliva
  1mg 2.5mg 25mg (Flint)  10mg (Regenerate) 25mg (Regenerate)
Placebo-adjusted change in ALT, wk 12  10mg* 12mg  17mg 12mg 21mg
LDL change from baseline  +5mg/dl +6mg/dl +25mg/dl +14mg/dl +20mg/dl
Generalised pruritis  9% 47% 23% 28% 51%
*Not statistically significant. Source: Enanta presentation. 

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