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AM-Pharma Raises €116m [$133m] to Conduct Pivotal Phase III Trial of recAP in Acute Kidney Injury

July 16, 2019 Off By BusinessWire
  • Financing co-led by new investors LSP and Andera Partners, with participation of existing investors Forbion, Ysios Capital, Kurma Partners, ID Invest Partners, BB Pureos Bioventures and Gilde Healthcare
  • Proceeds to be used for the 1,400-patient international pivotal Phase III trial of recombinant human Alkaline Phosphatase (recAP) in patients with sepsis-associated acute kidney injury (SA-AKI)
  • AKI is a devastating disease, with a high mortality rate and no approved pharmacological treatments

 

BUNNIK, Netherlands–(BUSINESS WIRE)–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 €116m [$133m] 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.

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Notes to Editors

About AM-Pharma

AM‐Pharma is 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). AKI affects millions of patients worldwide. It is a devastating disease with high mortality rate and no approved pharmacological treatments. AM-Pharma reported positive results from a Phase II study of recAP in patients with sepsis associated AKI (SA-AKI) and the Company is preparing to initiate a pivotal Phase III trial of recAP in patients with SA-AKI. AM-Pharma is also exploring the development of recAP for other indications including ulcerative colitis (UC), necrotizing enterocolitis (NEC) and hypophosphatasia (HPP). Founded in 2001, AM-Pharma is a private company that is based in the Netherlands. The Company is backed by a strong syndicate of international investors, both Venture Capital funds and Corporate Venture Funds, and has raised over €195m in equity and debt to date.

Find out more about us online at: www.am-pharma.com.

About Acute Kidney Injury (AKI)

Acute Kidney Injury (AKI) involves inflammatory processes in the kidney which can lead to complete loss of renal function. Hospital‐acquired AKI affects annually around 3 million patients in Europe, the US and Japan, and is associated with mortality in roughly 700,000 patients. It occurs in 40-60% of critical care admissions. Depending on the severity and cause of renal injury, mortality ranges from 10% to as high as 60%. In the US alone, hospitals spend around $10 billion each year on managing this major medical problem. The most important causes of AKI are sepsis, cardiovascular surgery, exposure to nephrotoxic drugs and trauma. Currently the only treatment options are dialysis and supportive care. No drugs are approved to treat this condition. Typically, these patients are treated in Intensive Care Units, often with support of nephrologists.1,2,3,4

References

  1. U.S. Food and Drug Administration; available at http://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
  2. Murugan R. and Kellum J.A., (2011) Nat Rev Nephrol. Vol 7: 209-217
  3. Heung M. and Chawla L., (2014) Nephron Clin Pract. Vol 127: 30-34
  4. Chertow et al., (2005) J Am Soc Nephrol. Vol 16: 3365-3370 Soc Nephrol. Vol 16: 3365-3370

AKI – recAP Mechanism of Action

Acute Kidney Injury (AKI) is a severe inflammation and damage of the kidney resulting in a sudden drop in kidney function, which can sometimes result in complete kidney failure. AM-Pharma has discovered that one key function of the enzyme Alkaline Phosphatase (AP) is to protect organs against inflammation and tissue damage.

AP acts as a detoxifying agent by removing phosphate from extracellular substrates. The dephosphorylation of pro-inflammatory substances like lipopolysaccharides (LPS) and extracellular ATP plays an important anti-inflammatory role. Research has shown that ATP dephosphorylation has a double effect in protecting against kidney injury. When the pro-inflammatory ATP is dephosphorylated the resulting adenosine further reduces inflammation through the activation of the immunosuppressive adenosine A2a receptor pathway (A2aR).

About recAP

AM-Pharma’s therapeutic candidate, recAP (recombinant Alkaline Phosphatase), is a proprietary recombinant human AP constructed from two naturally occurring human isoforms of the AP enzyme. recAP is highly stable and active and has a dual mechanism of action via dephosphorylation of lipopolysaccharides (LPS) and extracellular ATP. AM-Pharma has shown that treatment of patients with exogenous AP not only reduces local and systemic inflammation but also protects the kidney against further damage.

Awarded fast track designation by the US Food and Drug Administration in 2016, recAP has the potential to be a first-in-class medicine. The results of an adaptive Phase II STOP-AKI study of recAP in 301 sepsis patients with AKI were published in 2018 in the prestigious Journal of the American Medical Association (JAMA). recAP demonstrated a significant relative reduction in mortality of more than 40% in the treatment group compared to the placebo group without any safety observations of concern. AM-Pharma is now preparing for the pivotal Phase III study of recAP in patients with sepsis associated kidney injury.

About LSP

LSP (Life Sciences Partners) is an independent European investment firm, providing financing for private and public life sciences companies. LSP’s mission is to connect investors to inventors, focusing on unmet medical needs. Since the late 1980s, LSP’s management has invested in over 100 innovative enterprises, many of which have grown to become leaders of the global life sciences industry. With over €2.0 billion ($2.3 billion) of investment capital raised to date and offices in Amsterdam, Munich and Boston, LSP is one of Europe’s leading life sciences investors. LSP also invests in public companies through its Euronext-listed LSP Life Sciences Fund (Bloomberg: LSP NA).

For more information, please visit: www.lspvc.com.

About Andera Partners

Created in 2001 as part of the Edmond de Rothschild Group, Andera Partners is a leader in investments in unlisted companies in France and internationally. It manages nearly €2.3 billion in investments in life sciences, growth and buyout capital and sponsorless mezzanine debt. Andera Partners is 100% owned by its teams and places service to entrepreneurs and respect for partners at the heart of its concerns. The company is also a signatory to the United Nations Principles for Responsible Investment (UNPRI), which encourage the adoption of best environmental, social and governance (ESG) practices. Based in Paris, Andera Partners is an AMF-approved asset management company that employs 64 people, 44 of whom are investment professionals. It is structured as a partnership and managed by a board of 10 partners. Its Life Sciences team of 12 professionals brings together deep experience both in the Life Science industry and in private equity and venture capital. The team has raised more than €800 million through its BioDiscovery franchise and is currently investing out of its €345 million BioDiscovery 5 fund.

For more information, please visit: www.anderapartners.com.

Additional Financing Information

AM-Pharma’s funding round is supported by InnovFin Equity and benefits from the financial backing of the European Union under the European Fund for Strategic Investments (“EFSI”) set up under the Investment Plan for Europe and is co-financed by the Dutch State. The purpose of EFSI is to help support financing and implementing productive investments in the European Union and to ensure increased access to financing.

Contacts

For further information, please contact:

At the Company

AM-Pharma

Erik van den Berg, CEO

[email protected]

For media enquiries

Instinctif Partners (UK/RoW)

Sue Charles/Ashley Tapp

+44 (0)20 7866 7923

[email protected]

LifeSpring Communications (NL)

Leon Melens

+31 (0) 6 538 16 427

[email protected]