ENTA’s EDP-305 encountered pruritus at 25mg—but not at 5mg and lower doses, which provides a large therapeutic window (see below).
In the phase-2b trial where top-line data will be reported soon, the EDP-305 doses are 1.0mg and 2.5mg in tablet* form.
EDP-305 did not show an LDL increase at any dose.
As drug-developers move from first-generation agents (ICPT’s Ocaliva) to second-generation agents (ENTA’s EDP-305), it’s not uncommon to see a steep drop in the dose such as the 90% reduction that pertains in this instance.
*ENTA says the 1.0mg and 2.5mg tablets have equivalent drug exposure to the prior suspension-formulation doses of 2.0mg and 5.0mg, respectively.
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