Recruitment of 301 patients in STOP‐AKI adaptive Phase II trial   marks largest ever therapeutic study in AKI  

Bunnik, The Netherlands, 22 May 2017. AM‐Pharma B.V., a biopharmaceutical company focused on the development of recombinant human Alkaline Phosphatase (reCAP) for inflammatory diseases, announced completion of recruitment in the adaptive Phase II trial to treat sepsis patients with Acute Kidney Injury (AKI). The trial, titled A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA‐AKI (STOP‐AKI), completed recruitment with 301 patients, which makes it the largest interventional clinical study in AKI to date. 

The STOP‐AKI adaptive Phase II trial is being conducted in two parts. First, data from 131 patients were evaluated to select the most effective dose of recAP. Second, an additional 170 patients were recruited into two arms, receiving either the optimal dose of recAP identified initially, or placebo. The study was conducted in more than 50 intensive care units (ICU) in Western Europe and North America. 

Erik van den Berg, CEO of AM‐Pharma said: “We are pleased to announce that we have enrolled the last patient in the STOP‐AKI trial. I would like to express my appreciation to all staff in the investigating ICUs for their dedication and diligence in supporting the trial. We will now enter a new and exciting phase of patient follow‐up, data analysis and discussions with our scientific advisors. We anticipate publishing and 
presenting results from the trial in early 2018.”

In May 2015, Pfizer Inc. (NYSE:PFE) acquired a minority equity interest in AM‐Pharma and secured an exclusive option to acquire the remaining equity in the company. The option becomes exercisable upon completion of the STOP‐AKI trial.

In April 2016, AM‐Pharma received fast track designation from the U.S. Food and Drug Administration (FDA) for recAP in the treatment of AKI. The fast track designation facilitates the development and expedites the review process of drugs designed to treat severe conditions with unmet medical need.1 This status also enables a continuous dialogue with the FDA around the clinical and regulatory development of recAP.

Company contact: 
AM‐Pharma 
Erik van den Berg (CEO)  
+31 30 259 8838 

Media contact:          
80th Atom             
Adam Michael             
+44 1223 511338            
+44 777 588 1813 
[email protected]

Notes to Editors  

About AM‐Pharma www.am‐pharma.com   
AM‐Pharma is a biopharmaceutical company focused on the preclinical and clinical development of recAP (recombinant Human Alkaline Phosphatase) as a treatment of Acute Kidney Injury (AKI), Ulcerative Colitis (UC),  and  Hypophosphatasia  (HPP).  Based  on  strong results  from  Phase  II  trials  with  bovine  Alkaline Phosphatase in AKI and UC, AM‐Pharma  developed an  innovative  recombinant form of  human  Alkaline Phosphatase (recAP), and has completed recruitment of 301 patients in the STOP‐AKI adaptive Phase II trial 
for sepsis‐associated AKI. In May 2015, AM‐Pharma entered an agreement with Pfizer. Under the terms of the  agreement,  Pfizer  made an  upfront  payment  of  $87.5  million  for  a  minority  equity  interest,  and obtained an exclusive option to acquire the Company, with additional potential payments of up to $512.5 million upon option exercise and potential launch of any product that may result from the agreement. 

About Acute Kidney Injury  

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  as  many  as  4%  of  hospital admissions  and  40%  of  critical  care  admissions.  Depending  on  the severity  and  cause  of  renal  injury, mortality ranges from 10% to as high as 70%. 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.  AKI  patients  that  need  dialysis  have  the  worst prognosis. Currently the only treatment option is 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.2,3,4 

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, which is highly stable and active. It is in Phase II development for the potential treatment of AKI, with the potential to be developed for HPP. An oral formulation has been developed for the treatment of UC. The enzyme is produced by cGMP manufacture for preclinical and clinical trial supply and commercialization.

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

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