Oramed, a subsidiary of Oramed Pharmaceuticals, has signed an agreement with Medpace to retain Medpace as a Clinical Research Organization (CRO) for its upcoming ORMD-0801 phase II clinical trial.
Subscribe to our email newsletter
The FDA-approved trial will examine the safety and efficacy of ORMD-0801 in 147 patients at multiple centers across the US.
Oramed is expected to commence the trial after receiving investigative new drug application approval from FDA.
Oramed CEO Nadav Kidron said the collaboration represents a milestone for the company.
"After much due diligence, we decided to join forces with the experts at Medpace and look forward to working with them on the FDA-approved clinical trial of our oral insulin capsule," Kidron added.
Medpace medical and regulatory affairs vice president and former FDA director Orloff will design and implement the upcoming trial.