AM-Pharma raises 116 million euros to conduct pivotal phase 3 trial of recap in acute kidney injury
AM-Pharma B.V., 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) announced that it has raised €116m from a European syndicate of new and existing investors. These new funds will be used to carry out a multi-national pivotal Phase III trial of recAP in 1,400 patients with sepsis-associated acute kidney injury (SA-AKI). Last year AM-Pharma reported promising results from its STOP-AKI Phase II clinical trial, which demonstrated significant improvements in survival and kidney function.
The financing round was co-led by new investors LSP and Andera Partners, and includes founding investor Forbion together with other existing investors, Ysios Capital, Kurma Partners, ID Invest Partners, BB Pureos Bioventures and Gilde Healthcare.
AKI is a devastating disease, with a high mortality rate and no approved pharmacological treatments. The most important cause of AKI, which affects millions of patients worldwide, 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 AKI.
The results of AM-Pharma’s adaptive Phase II STOP-AKI study of recAP in 301 sepsis patients with AKI, demonstrated a significant relative reduction in mortality of more than 40% in the treatment group compared to the placebo group. Whilst the primary endpoint – short term kidney function – was missed, long-term kidney function was significantly improved. Throughout the study, recAP was shown to be safe and well tolerated. These results were published in the Journal of the American Medical Association (JAMA).3
This new capital will be used to support the largest ever clinical trial in SA-AKI, seeking to enroll up to 1,400 patients with SA-AKI at multiple sites in approximately 12 countries. Following recent discussions with regulatory authorities in the US and Europe, AM-Pharma plans to submit market authorization applications following the successful completion of this upcoming single pivotal Phase III study.
Erik van den Berg, AM-Pharma’s CEO commented: “Raising this amount of capital from highly experienced life sciences venture capital firms LSP and Andera Partners, with continued support from our existing investors, highlights the urgent medical need in AKI and the potential of recAP as a life-saving treatment. We look forward to working with our expanded investor syndicate and to initiating the Phase III trial.”
Martijn Kleijwegt, Managing Partner at LSP added “We have been following the AM-Pharma story for some time and are delighted to have the opportunity to co-lead this financing round. With its promising Phase II recAP data published last year, this is an exciting time to support the Company as it is poised and ready to start the Phase III clinical study. recAP has the potential to become the first pharmacological treatment and a blockbuster first-line therapy for critically ill patients with SA-AKI.”
Raphaël Wisniewski, Partner at Andera Partners added “We were very impressed with the concept-to-clinic work that AM-Pharma has carried out. This includes the development and cGMP manufacture of recAP, gaining an understanding of its mechanism of action, designing and running an adaptive Phase II clinical trial and, most importantly, its positive impact on patients with SA-AKI. On this journey AM-Pharma has matured from a start-up to a clinical-stage biopharmaceutical company with an in-depth understanding of the underlying and complex causes of AKI. We look forward to these valuable insights translating to future treatment for patients with renal and other diseases of high unmet medical need.”
AM-Pharma’s Board of Directors will consist of Martijn Kleijwegt and Felice Verduyn van Weegen from LSP, Raphael Wisniewski from Andera, Remi Droller from Kurma and Geert-Jan Mulder from Forbion.
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.
3. Pickkers P, Mehta, RL, Murray PT et al., Effect of Human Recombinant Alkaline Phosphatase on 7-Day Creatinine Clearance in Patients With Sepsis-Associated Acute Kidney Injury A Randomized Clinical Trial. JAMA. 2018;320(19):1998-2009.
Source: AM-Pharma
Watch our video with Erik van den Berg, CEO of AM-Pharma of 2015 on access to funding: