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AM-Pharma returns to clinic with Phase I trial of new recombinant human Alkaline Phosphatase


AM-Pharma returns to clinic with Phase I trial of new recombinant human Alkaline Phosphatase to treat Acute Kidney Injury

Trial to reaffirm safety seen in previous Phase I & II trials of bovine Alkaline Phosphatase

Bunnik, The Netherlands, 23 September 2013. AM‐Pharma B.V., a biopharmaceutical company focused on
the development of recombinant human Alkaline Phosphatase (AP) for inflammatory indications is
pleased to announce that the first subjects have entered a Phase I trial of its recombinant AP (recAP) to
treat Acute Kidney Injury (AKI).
This is a significant milestone in the progress of AM‐Pharma, as it re‐enters the clinic with its new
recombinant AP product. The Company previously presented strong, positive, Phase II data on an
enzymatically comparable bovine extracted AP, which showed that AKI patients on AP had improved renal
function, reduced length of stay in intensive care, and that AP was safe and well tolerated.
The Phase I study of recAP consists of 50 healthy volunteers, aims to confirm safety and tolerability, and
investigate the pharmacology including enzyme activity in serum – a key indicator of the drug’s
therapeutic potential.
Recruitment to the trial will close in December 2013, with the results reporting in early 2014.
Confirmation of the results seen in the previous bovine AP trials will enable the Company to seek approval
for Phase II development in Q2 2014.
Erik van den Berg, CEO of AM‐Pharma said, “We are delighted to be re‐entering the clinic with our
recombinant Alkaline Phosphatase, recAP. Our previous, statistically significant and clinically‐relevant,
studies with bovine AP have shown the product to be a very promising, safe, and effective treatment for
Acute Kidney Injury – a multi‐billion dollar market for which there are no current drugs. We believe recAP
has favourable characteristics over the bovine form, and with scalable production makes for a
commercially viable product.”
For further information please contact:
80th Atom AM‐Pharma
Adam Michael Erik van den Berg (CEO)
+44 1223 511338 +31 30 259 8838
+44 777 588 1813
Adam@80thAtom.com
Notes to Editors:
About AM‐Pharma www.am‐pharma.com
AM‐Pharma is a biopharmaceutical company focused on the preclinical and clinical development of
Alkaline Phosphatase as protective treatment of acute kidney injury and inflammatory bowel diseases.
AM‐Pharma is based in Bunnik, The Netherlands. Based on the strong results of the Phase II trials with
bovine Alkaline Phosphatase in Acute Kidney Injury and a Phase II trial in Ulcerative Colitis – a form of
inflammatory bowel disease ‐, AM‐Pharma developed an innovative recombinant form of human Alkaline
Phosphatase. This recombinant Alkaline Phosphatase will be used in future trials and for
commercialization. AM‐Pharma raised €29.2M in Q4 2011, enabling AM‐Pharma to finalize the GMP
production and the development through phase II.
About Acute Kidney Injury
Acute Kidney Injury (AKI) involves an inflammatory process in the kidney which can lead to complete loss
of renal function. Hospital‐acquired AKI affects annually around 2 million patients in Europe, US and
Japan, of which around 700,000 patients die. 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, around USD10 billion is spent each year on managing this big 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, often with support of nephrologists. Due to the large number of
patients suffering from AKI, the high medical need, worldwide annual sales of over USD2 billion could be
achieved with an effective drug treatment.
About Alkaline Phosphatase
Alkaline Phosphatase (AP) is an enzyme that is naturally present in humans on epithelial cells of the
gastrointestinal tract, kidney, liver and lungs. An important role of AP is the dephosphorylation of
proinflammatory substances like lipopolysacharides (LPS) and extra‐cellular ATP. The anti‐inflammatory
characteristics of AP was firstly published by professor Poelstra and his group at Groningen University, the
Netherlands. AM‐Pharma has since shown that treatment with exogenous AP not only reduces local and
systemic inflammation but also protects the kidney against further damage.
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. This
hybrid is highly stable and active, and has been optimized for treating inflammatory conditions. It is being
developed as an injectable for the treatment of Acute Kidney Injury and an oral formulation for Ulcerative
Colitis. The enzyme is being produced by cGMP manufacture for preclinical and clinical trial supply and
commercialisation.
– ENDS –


Publisher Contact Information:

AM-Pharma BV
+31 30 259 8838
-

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