UK-based pharmaceutical company Ergomed has begun patient enrolment in a proof-of-concept Phase IIb clinical trial of peprostat to control intraoperative surgical bleeding.
Based on a synthetic peptide, peprostat eliminates the risk of exposure to blood derived materials, is stable and has a fast mode of action.
The trial will enrol a total of 120 patients in up to 30 centres across seven European countries.
The randomised, placebo controlled, double blind Phase II trial will evaluate the safety and efficacy of peprostat during liver, soft tissue, vascular and spinal surgical procedures.
Ergomed chief executive officer Dr Miroslav Reljanovic said: “The initiation of this Phase IIb trial is another important milestone for Ergomed, following the acquisition of Haemostatix.
"We believe that peprostat can overcome the disadvantages associated with the use of current products for intraoperative surgical haemostasis.
"We believe that we have a good chance of obtaining successful results, and with that a compelling data package to advance the product into late-stage development and commercial collaboration.”
The trial's primary objective is to assess the efficacy of peprostat to control bleeding during surgery.
A Phase I clinical trial conducted in 20 liver surgery patients in the UK demonstrated that peprostat was safe, fast and effective.
The top-line results from the Phase II trial are expected to be reported in the first quarter of next year.
With operations in more than 50 countries, Ergomed provides clinical development, trial management and pharmacovigilance services to more than 100 clients.
The firm develops oncology, neurology and immunology and orphan drugs.