Ergomed completes recruitment in PeproStat study six months early

The AIM-traded firm described PeproStat as its “highly innovative” new coagulant, or ‘haemostat’, for intraoperative surgical bleeding.

As it had previously announced, with recruitment completed ahead of schedule, the trial was expected to report topline data in the fourth quarter.

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

Ergomed’s board said PeproStat is a “potentially disruptive” product which could enter a global haemostat market estimated to be worth $2.8bn in 2020.

It claimed current products may be limited by “a range of issues”, including slow onset of action and long preparation time.

PeproStat, based on a synthetic peptide which reportedly eliminates the risk of exposure to blood derived materials, is said to be more stable, allowing the formulation of ready-to-use preparations with a fast mode of action.

More than 160 patients had now been enrolled in the randomised, placebo controlled, double blinded Phase IIb study in up to 16 centres across five European countries.

The primary objective of the study was to evaluate the efficacy of PeproStat in controlling bleeding during surgery.

Ergomed aid the study was examining four different surgical procedures - liver, soft tissue, vascular, and spinal.

It followed on from a 20-patient UK Phase I study conducted in liver surgery patients, which indicated the product was safe, fast and effective.

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

“This, combined with the interest we have received for PeproStat from industry, underpins our strategy to generate value by developing new medicines as internal assets as well as shared-risk collaborations.”