01.10.2019

AM-Pharma Expands its Senior Team in Preparation for a Pivotal Phase III Trial of recAP in Acute Kidney Injury

  • Dr. Juliane Bernholz has joined as Chief Operating Officer
  • Ms. Kristie Bass has joined as VP Clinical Operations

Bunnik, The Netherlands, 1 October 2019 – 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 expanded its senior team with two appointments. Dr. Juliane Bernholz has joined as Chief Operating Officer (COO), and Ms. Kristie Bass as VP Clinical Operations (VP Clin Ops).

Erik van den Berg, AM-Pharma’s CEO commented: “I’d like to extend a warm welcome to Juliane and Kristie as they join our growing team here in The Netherlands. They both bring highly relevant international experience to their new roles which we look forward to utilizing as we prepare for the initiation of our pivotal Phase III trial of recAP in patients with sepsis-associated acute kidney injury. We are pleased to have attracted such high-quality, proven talent and believe that these new roles will contribute greatly to our future success.”

In her new role as COO, Dr. Bernholz will be accountable for overseeing all of AM-Pharma’s R&D programs, ensuring that they remain on track, are appropriately planned and executed across manufacturing, clinical, regulatory and all other relevant functions. She will also be responsible for supporting the Company as it transitions into the commercialization phase.

Dr. Bernholz brings broad international experience in clinical development, project management, regulatory affairs, business development and site leadership to her new role as COO. She most recently served as Compound Development Team Leader at Janssen R&D LLC in New Jersey, US. Before her time at Janssen, Dr. Bernholz held a number of international leadership roles at Sanofi with the Diabetes franchise, Novartis with the Critical Care franchise, and Actelion in pulmonary arterial hypertension. Dr. Bernholz, originally a cell biologist and molecular geneticist by training, will relocate from the US to The Netherlands.

Ms. Bass started her role as VP Clinical Operations in September. In this role she is responsible for the execution and reporting of all clinical trial programs at AM-Pharma, mainly focusing on the Phase III trial with patients with sepsis-associated acute kidney injury (SA-AKI). In addition, Ms. Bass will manage the growing clinical operations team including roles in data management, biostatistics, clinical research associates and medical writing.

Ms. Bass has over 18 years of experience in clinical research, including leading a number of Phase III registration trials in critical care and sepsis. Before she joined AM-Pharma, she worked as a Senior Director of Project Delivery at PRA Health Sciences, a clinical research organization (CRO) based in Raleigh, North Carolina, US and as Director, Project Management at PPD. Prior to her career in clinical research, Ms. Bass was an intensive care unit/emergency room nurse. Ms. Bass has relocated to The Netherlands from the US to start her new role.

In July, AM-Pharma announced that it had raised €116m [$133m] from a European syndicate of new and existing investors to help fund its pivotal Phase III trial of recAP in SA-AKI. This trial will be the largest trial ever conducted in SA-AKI and will seek to enroll up to 1,400 patients at multiple sites in approximately 12 countries. Further information on this trial including endpoints and timing will be shared over the next few months.

AM-Pharma is currently in the process of hiring for a number of new roles. Further information on these can be found on our website careers section, accessible here.

– ENDS –

For further information, please contact:

At the Company
AM-Pharma Instinctif Partners (UK/RoW) LifeSpring Communications (NL)
Erik van den Berg, CEO
e.vandenberg@am-pharma.com

For media enquiries
Sue Charles/Ashley Tapp
+44 (0)20 7866 7923
AM-Pharma@instinctif.com

Leon Melens
+31 (0) 6 538 16 427
lmelens@lifespring.nl

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. S. Food and Drug Administration; available at

http://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm

  1. Murugan R. and Kellum J.A., (2011) Nat Rev Nephrol. Vol 7: 209-217
  2. Heung M. and Chawla L., (2014) Nephron Clin Pract. Vol 127: 30-34
  3. 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.


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