Fresh off a $25 million IPO, Evoke Pharma ($EVOK) is riding into Phase III with its gastroparesis-treating nasal spray, and now the biotech has recruited SynteractHCR to serve as its go-to CRO for the late-stage effort.
Evoke is developing an inhalable formulation of metoclopramide to treat diabetic women with gastroparesis, a condition that leaves the stomach unable to empty its contents. With SynteractHCR on board, Evoke is now in the midst of site selection for its Phase III study, planning to enroll about 200 patients at 60 centers across the country.
The latest partnership builds off the pair's success in mid-stage trials, Evoke CEO Dave Gonyer said, as SynteractHCR served as the primary CRO in a 287-patient Phase IIb study of EVK-001, the company's sole product.
"As we prepare to commence this important initiative, we believe the selection of the same CRO and the planned inclusion of many of the same Phase IIb study sites will maximize the use of our knowledge base to expedite initiation and completion of Phase III," Gonyer said in a statement. "We remain encouraged by EVK-001's clinical potential as we prepare to enter Phase III and are excited by its longer-term commercial prospects."
For SynteractHCR, the deal adds to its growing list of commitments in the U.S. and abroad. The CRO has been expanding its reach since buying Germany's Harrison Clinical Research and rebranding itself in March.
- read the statement