CRO tapped for Evoke comparative exposure PK trial

24-Apr-2017 - Last updated on 25-Apr-2017 at 13:53 GMT

The clinical trial is designed to establish bioequivalence with Reglan. (Image: iStock/styf22)

Spaulding Clinical Research will conduct Evoke Pharma’s planned comparative exposure pharmacokinetic (PK) trial for its lead product candidate, Gimoti.

The Wisconsin-based contract research organization (CRO) operates a 200-bed clinical pharmacology unit, cardiac core laboratory and provides biometrics/scientific affairs services.

“Evoke Pharma has contracted Spaulding Clinical Research to complete its required pharmacokinetic (PK) trial for its lead drug candidate Gimoti, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus,” Dave Gonyer, Evoke CEO told Outsourcing-Pharma.com.

The PK trial will be conducted in healthy volunteers and is designed to establish bioequivalence with the currently listed drug, Reglan.

“Evoke believes that a nasal formulation of metoclopramide serves as an optimal delivery method for the treatment of gastroparesis due to the nasal administration of the drug that bypasses the GI absorption issues that currently plagues oral administration,” Gonyer explained.

Additionally, poor medication absorption is often exacerbated by nausea and vomiting, which are common symptoms of gastroparesis, he added.

FDA meetings

To date, Evoke has had three meetings with the FDA, including two face-to-face meetings in August and December 2016. Another phone meeting was held in March 2017 for “even further clarity,” Matt D’Onofrio, CBO, told us.

“The first meeting in August was to discuss and confirm various regulatory, CMC, and non-clinical requirements for a potential NDA submission,” he added.

The second meeting in December was held to discuss the company’s clinical data focusing on the inclusion of additional data for a 505(b)(2) NDA filing.

“As a result of this meeting, the FDA agreed that a demonstration of equivalent exposure to Reglan in a comparative exposure PK trial could serve as a portion of its NDA submission package for Gimoti,” explained D’Onofrio. “This has helped lay a clear path forward for a 505(b)(2) NDA filing for Gimoti.”

The most recent was a Type A Meeting with FDA to discuss the protocol and CMC items for the comparative bioequivalence study. “FDA was in agreement with the protocol and CMC strategies,” added D’Onofrio.

Moving forward the company plans to have results for its PK trial in the second half of 2017 with an NDA submission in the fourth quarter of 2017 or early 2018.