Ergomed plc completes recruitment for phase IIb study of PeproStat ahead of schedule

() has completed the recruitment of patients for its phase IIb study of its blood thickening agent, six months ahead of schedule.

The trial of PeproStat, which is used to staunch bleeding during surgery, is expected to report top line data in the fourth quarter of 2017.

More than 160 patients have enrolled in the phase IIb study in up to 16 centres across five European countries.

“We are delighted to have completed recruitment of the PeproStat Phase IIb trial about six months ahead of schedule,” said chief executive, Dan Weng.

“This demonstrates not only strong physician interest in this innovative haemostat, but also Ergomed’s ability as a specialist drug developer to efficiently recruit patients fit for study purpose. We look forward to seeing data later this year.”

The thickening agent has the potential to tap into the haemostat market, worth an estimated US$2.8bn in 2020. Ergomed expects the product will gain significant market share given its benefits as a stable and fast-acting agent.

The phase IIb study will examine the use of the agent in different surgical procedures, including of the liver, soft tissue, vascular, and spinal. The aim of the trial is to evaluate its efficacy of PeproStat in controlling bleeding during surgery. 

It follows a 20-patient UK phase I study conducted in liver surgery patients that indicated the product was safe, fast and effective.

PeproStat is Ergomed’s lead product in its Haemostatix portfolio, with ReadyFlow in mid-stage pre-clinical development. The two products are estimated to have peak sales potential of more than $500mln, Ergomed said.

“We are excited to see that the lead product from our Haemostatix acquisition is developing rapidly towards late stage development and commercial collaborations,” said executive vice-chairman, Dr Miroslav Reljanovic.

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