AM-Pharma gathers €116M for PhIII program on kidney drug Pfizer passed on
Back in 2015, Pfizer put a spotlight on Dutch biotech AM-Pharma and its drug candidate for sepsis-associated acute kidney injury, anteing up $87.5 million for a minority stake in addition to an option to gobble the whole operation up. The Phase II trial that the giant partner had bet on ended up delivering a mixed win, and Pfizer walked away from the deal citing “internal strategic reasons” — leaving the small player on its own to pull off a large Phase III study and ponder commercialization.
A year and a half after that data readout, AM-Pharma is going for it. In lieu of one deep-pocketed ally, it’s assembled a group of top-tier European investors to back its final stretch in the clinic.
LSP and Andera Partners co-led the €116 million ($133 million) round, joining founding investor Forbion and other existing supporters: Ysios Capital, Kurma Partners, ID Invest Partners, BB Pureos Bioventures and Gilde Healthcare.
The Phase III program will recruit 1,400 patients across 12 countries to test whether AM-Pharma’s recombinant human alkaline phosphatase (recAP) can indeed reduce the mortality rate due to kidney damage induced by the body’s overwhelming response to infections.
The 40% reduction noted in the previous Phase II was what gave van den Berg confidence despite the drug not hitting the primary endpoint of improving kidney function in 7 days.
“Short term kidney function improvement was really more a design for the Phase II study to be able to pick the most optimal dose,” he said. “It’s kind of a biomarker if you like. For Phase III one has to choose hard clinical endpoints, and the most preferred endpoint by the regulators is the mortality in this setting.”
And it’s not hard to see why. With millions of patients suffering from acute kidney injury each other — half of which are associated with sepsis — and 700,000 deaths around the world annually, making a dent in that would mean a blockbuster opportunity.
RecAP works by dephosphorylating substances that can trigger the immune system into devastating the kidney, thus dexotifying them and reducing the inflammation.
“From our interactions with FDA and EMA last year, we just need to conduct one single positive pivotal study to file for market approval,” he tells me, adding that the drug has secured fast track designation in the US.
He plans to bring the company’s headcount up from 15 to as many as 30 to complete the clinical work and perhaps begin laying some groundwork for launch.
Following the financing the board will also expand, comprising Martijn Kleijwegt and Felice Verduyn van Weegen from LSP, Raphael Wisniewski from Andera, Remi Droller from Kurma and Geert-Jan Mulder from Forbion.