The AIM-listed company said in a statement that the coagulant met the primary endpoint over standard of care (SOC) in time to haemostasis – i.e. it stopped the flow of blood quicker than current treatments – with “statistical significance” in all surgery types tested.
In total, PeproStat reduced the average time needed to stop a patient’s bleeding by more than 1.5 minutes. Just over 58% of patients reached haemostasis within 2 minute, compared to less than a third treated with the current SOC.
Not only was it effective, Ergomed said PeproStat was also safe with no treatment-related serious adverse events (SAEs) or re-bleeding reported.
More investigators were said to have found the product “good to excellent” with respect to control of the bleeding versus the current standard of care, while more also said it was easy or very easy to use.
Various funding discussions on the table
“We believe PeproStat is a first-in-class product which could enter the large and growing haemostat market as early as 2020,” said chief executive Dan Weng.
“We have already completed our first commercial agreement for PeproStat and our other haemostat, ReadyFlow, with Boryung in September, and will now explore our options to bring this first-in-class haemostat to the market as soon as possible.
“Currently, we have a number of active licensing and partnering discussions to fund further development.”
Phase III trial due in 2018
After the strong Phase II results – which have come in ahead of schedule – the next step for Ergomed is to prepare for PeproStat’s Phase III trial which is earmarked for some point next year.
As Weng noted, the thickening agent has the potential to tap into the haemostat market, worth an estimated US$2.5bn, in 2020. Ergomed expects the product will gain significant market share given its benefits as a stable and fast-acting agent.
Numis boosts target price after ‘encouraging’ data
Analysts at Numis said today that the “encouraging” initial data increases the probability of PeproStat eventually moving into phase III trials to 75% (from 40%). If a partner can be found, they reckon it’s a certainty to move into phase III.
As a result, Stefan Hamill and co reckons shares are now worth 300p – up from their previous target of 280p. That's 25% or so above where the shares currently sit, at around 217p.
“We see this as encouraging data that shows PeproStat controls bleeding quickly and is a convenient, easy to use product for physicians,” wrote the analysts in a note.
“This initial headline data and the greater convenience of PeproStat over existing therapies makes us more confident that Ergomed can bring on partners to help fund Phase 3 studies and commercialisation, with a number of discussions underway.”
First commercialisation deal for PeproStat already signed
Ergomed has already signed commercialisation deals for both PeproStat and its other haemostat product ReadyFlow – both of which the company acquired when it snapped up Haemostatix for US$28mln last year.
ReadyFlow is a blood-free haemostatic gel and is expected to enter phase I trials next year.
The deal is with Korean company Boryung Pharmaceutical, and will see Ergomed receive a double-digit percentage share of all future PeproStat and ReadyFlow sales in South Korea.
Ergomed also also receive an up-front fee and a series of milestone payments.
The company has previously said that similar deals in other territories are in the pipeline.
Hybrid business model
It’s tough for small pharma companies to carry out pioneering drug research.
Ergomed's finance director Stephen Stamp believes its model is the only way it can be done realistically.
The company is a pharmaceutical hybrid, a pharma services firm that also takes a stake in drugs during the development process.
That means as well as a profitable services business, it also has exposure to a number of new treatments making their way through clinical trials.
Not just PeproStat and ReadyFlow...
Ergomed has four partnership deals in the portfolio - with Asarina, CEL-SCI, Ferrer and Modus Therapeutics but wants to increase its co-development portfolio to 10 agreements in the medium term.
Another partnership with a different partner - Aeterna Zentaris - failed earlier this year, but the company still has its fingers in lots of pies.
Other co-development deals include one with Asarina Pharma AB for Sepranolone. Ergomed will conduct the phase IIb clinical study of this treatment designed for women suffering from premenstrual dysphoric disorder (PMDD).
Another of its partners – Modus - is developing Sevuparin, a potential treatment for sickle cell disease, which is in a phase 2 clinical trial.
€5.7mln acquisition of niche contract research organisation
At the end of September Ergomed announced it was paying up to €5.7mln to acquire Dutch-based PSR Group BV, a niche contract research organisation (CRO) specialising in orphan drug development.
To fund part of that deal, the AIM company undertook a share placing to raise £2.9mln.
Speaking at the time, CEO Weng said: “This acquisition aligns with the strategy laid out at IPO of seeking to grow our existing, profitable service business both organically and through strategic acquisitions, and specifically of becoming a leader in orphan drug development.”
He added: “PSR has successfully demonstrated its leading capabilities in this area and its addition to the Group complements Ergomed's existing highly-regarded orphan disease specialist.”