Evoke reports more data for EVK-001

Evoke Pharma Inc. (NASDAQ:EVOK) said 10 and 14 mg doses of EVK-001 given four times per day each missed the primary endpoint of reducing modified daily diary version of the Gastroparesis Cardinal Symptom Index (mGCSI-DD) total score from baseline to week four vs. placebo in a Phase IIb trial to treat diabetic gastroparesis. EVK-001 did significantly reduce the score from baseline to week four vs. placebo in the pre-specified subgroup of women, but neither dose led to a significant reduction in the pre-specified subgroup of men. The double-blind, U.S. trial enrolled 287 Type I or Type II diabetics with symptoms associated with acute and recurrent gastroparesis. Data were presented at the Digestive Disease Week meeting in Chicago.

Evoke is conducting a pair of Phase III trials with EVK-001 -- one in women and one in men -- with both trials slated to be completed by 2015. The company said the trial in women will be used to submit a regulatory application for EVK-001 to FDA. According to Evoke, more than 80% of patients with diabetic gastroparesis are female. EVK-001 is an intranasal formulation of metoclopramide, a dopamine D2 receptor antagonist. Oral and IV formulations of metoclopramide are available as generics to treat gastroparesis. ...