=Evoke Pharma (EVOK) : positive topline results for Gimoti

Headquarters: Solana Beach, CA
Founded: 2007
evokepharma.com


Evoke Pharma announces 'positive' topline results from its comparative exposure pharmacokinetic study; co will submit a 505(b)(2) NDA with a selected Gimoti dose to the FDA in 1Q18

The PK study was an open label, 4-way crossover and enrolled 108 male and female healthy volunteers who were each to receive one Reglan Tablet dose and three different doses of Gimoti in a random sequence.

• Following discussions at pre-NDA meetings with FDA, Evoke planned to select a Gimoti dose based on criteria that includes a 90% confidence interval for the ratio of area under the plasma concentration curve (AUC) falling within the bioequivalence range of 80-125% of the RLD. Two of the three doses tested met the selection criteria.
• The maximum observed plasma concentration (Cmax) for Gimoti was slightly lower than the bioequivalence range, which had been previously discussed with FDA as a likely outcome given the different route of administration and prior Gimoti PK study results.
• Additionally, data showed the AUC and Cmax increased in a dose related manner across all three strengths tested.
• Relative to safety, all Gimoti doses were well-tolerated with no clinically significant adverse events reported following any of the doses.