Unfazed by disruptions, Cowen's investment arm backs AM-Pharma's $176M pivotal plan around lethal condition
It may not be the best time to start up a late-stage study unrelated to Covid-19, but AM-Pharma isn’t letting a slight delay derail its overall plan.
The Dutch biotech has been singularly focused on recAP, an anti-inflammatory recombinant human form of an enzyme originally found in cows called alkaline phosphatase.
The one Phase III it believes it needs for approval was scheduled for this summer, funded by a $133 million round last July. Having pushed study initiation to after the summer, AM-Pharma is adding $52 million for the regulatory work needed to prepare for launch, including CMC validation and commercial supply.
When the pandemic will peak is impossible to predict, said CEO Erik van den Berg, but given the severity of the disease that AM-Pharma is tackling — sepsis-associated acute kidney injury — they wanted to start as soon as possible and broadly stick to the original timeline. Data from the Phase III trial are expected in 2023.
The new €23 million equity investment by Cowen Healthcare Investments, its first US-based investor in the syndicate, alongside the €24 million loan from the European Investment Bank, has boosted his conviction.
Right now, with all of AM-Pharma’s 23 staffers working from home in Utrecht, the Netherlands, critical activities are still ongoing. Documents still need to be prepared for review before sites can be initiated — a sizable project when you are planning a trial involving 1,400 patients in 12 countries.
“Our work is mostly project management and coordination,” van den Berg said. “We don’t have any labs to close in this period. All of our suppliers are still online and also moved as much as possible to home-based working.”
There will be challenges when the trial actually begins, as the patients that will be recruited tend to be treated in intensive care units, many of which could be overwhelmed by severe coronavirus patients. While he is planning for different possibilities, van den Berg is hopeful human creativity will save them from the worst-case scenario.
In a sense it’s characteristic of a team that has built a business around offering hope where there is little, reducing the mortality rate by 40% versus placebo in Phase II. And it wouldn’t be the first time it has had to contend with unforeseen circumstances: van den Berg hadn’t been planning on taking the pivotal program and commercial efforts until Pfizer pulled out of a deal to acquire the company, leaving it to go it alone.
“Worst case scenario is we’re sitting in our home offices for years,” he said. ”But I don’t think that’s realistic. I don’t see it that bleak.”