AM-Pharma Increases Funding to €163m for Phase-III Trial of recAP in SA-AKI

AM-Pharma B.V. (‘AM-Pharma, the Company’), a clinical stage biopharmaceutical company leading in the development of a treatment for acute kidney injury (AKI) with its innovative recombinant human Alkaline Phosphatase therapeutic (recAP), today announces that it has raised additional funds of €47m [US$52m], increasing the total recent fundraising to €163m [US$176m].

This new capital will be used to support a multi-national pivotal Phase III trial of recAP in 1,400 patients with sepsis-associated-acute kidney injury (SA-AKI). It also allows the Company to fund the steps required to submit Marketing Authorization Applications following the trial’s completion, including CMC validation and commercial manufacture.

€23m has been mainly provided by Cowen Healthcare Investments, an affiliate of Cowen Inc., which joins the existing investor syndicate of LSP and Andera Partners, Forbion, Ysios Capital, Kurma Partners, ID Invest Partners, BB Pureos Bioventures and Gilde Healthcare that raised an initial €116m in July 2019.

The additional €24m has been provided by the European Investment Bank (EIB), under the “Infectious Diseases Finance Facility” (IDFF) of the InnovFin – EU-Finance for Innovators program, which is financed from the EU’s research and innovation program, Horizon 2020.

AKI is a devastating disease, with a high mortality rate which affects millions of patients worldwide and has no approved pharmacological treatments. The most important cause of AKI is sepsis.^1,2 AM-Pharma was awarded Fast Track designation by the US Food and Drug Administration in 2016 and recAP has the potential to be a first-in-class medicine for SA-AKI. The Phase III trial in reCAP will be the largest clinical trial in SA-AKI, seeking to enroll up to 1,400 patients with SA-AKI at sites in approximately 12 countries.

Erik van den Berg, AM-Pharma’s CEO commented: “This additional capital adds to the financing in July 2019, with the addition of the respected Cowen Healthcare Investments team to our international investor syndicate and support from the EIB. The Cowen team not only provides additional funds but also vast experience that can be drawn upon. We are also delighted with the award of funds from the EIB which is a great supporter of innovative medicines and will enable the building of our company.”

He added, “The funds raised for our recAP Phase III trial is now at €163m which will also support further marketing application readiness activities. The support from our shareholders and the EIB highlights the urgent medical need in SA-AKI and recAP’s potential to treat this indication. We look forward to working with our expanded investor syndicate and continuing work on recAP’s path to market.”

Tim Anderson at Cowen added “AM-Pharma has completed a robust 301 patient Phase II trial in SA-AKI, following a clear path based on regulatory feedback and the team has significant expertise in the field of acute kidney injury. We believe that recAP has the potential to be an important treatment option for AKI and other indications of high unmet medical need. We look forward to working with the team and the rest of the investors throughout the Phase III trial and beyond.”

References

1. Lameire NH, Bagga A, Cruz D, et al. Acute kidney injury: an increasing global concern. Lancet. 2013; 382(9887):170-179. doi:10.1016/S0140-6736(13) 60647-9

2. Hoste EA, Bagshaw SM, Bellomo R, et al. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med 2015;41:1411–23.