Accueil / Communiqués / JAMA Publishes Phase II recAP Data for Sepsis-Associated Acute Kidney Injury

JAMA Publishes Phase II recAP Data for Sepsis-Associated Acute Kidney Injury

Wednesday, October 24th 2018 at 12:00pm UTC

JAMA paper to be presented at ESICM conference in Paris
data on mode of action to be presented at ASN conference in San Diego

BUNNIK, Netherlands–(BUSINESS WIRE)– AM?Pharma B.V., a biopharmaceutical company focused on the development
of recombinant human Alkaline Phosphatase (recAP) for inflammatory
diseases, today publishes data in the prestigious Journal of the
American Medical Association
(JAMA) of its recently completed
STOP-AKI Phase II study of recAP in the treatment of sepsis-associated
Acute Kidney Injury (AKI). Simultaneously, the results will be presented
at today’s European Society of Intensive Care Medicine in Paris.
Additionally, new data on recAP’s mode of action will be presented
tomorrow (October 25th) at the American Society of Nephrology
Kidney Week in San Diego.

Professor Peter Pickkers, MD PhD, Chair of Experimental Intensive Care
Medicine, Radboud University Medical Center, and principal investigator
of the STOP-AKI study said: “Although the study did not meet its primary
endpoint of short-term improvement in kidney function in the first 7
days, it did show long-term improvement in kidney function and very
importantly a 40% relative reduction in mortality over placebo. In the
absence of any drugs approved for this condition, these exciting
clinical outcomes warrant further research to confirm these findings and
to make this treatment available to patients.”

Prof. Pickkers is presenting the results of the randomized clinical
study at today’s Hot Topics session at ESICM in Paris at 16:40 CET.

In addition, investigations at the institutions of Professor Mark D.
Okusa and Professor Bruce Molitoris revealed more detail into recAP’s
mode of action. Their research showed that protection from kidney injury
is mediated by dephosphorylation by recAP of ATP to adenosine and
activation of adenosine A2a receptors (A2aR).

Dr. Okusa, Professor of Medicine and Chief, Division of Nephrology and
Director, Center for Immunity, Inflammation and Regenerative Medicine at
University of Virginia, School of Medicine, and Dr. Molitoris, Professor
of Medicine, former Director of Nephrology and the Indiana Center for
Biological Microscopy at Indiana University noted: “The mode of action
appears to be an elegant, double effect; in the first instance recAP
inactivates pro-inflammatory ATP, and the resulting formation of
adenosine further reduces inflammation through the immunosuppressive
adenosine A2a receptor pathway.”

Professor Diane L. Rosin from Dr. Okusa’s research group will present
the results at the annual meeting of the American Society of Nephrology
in San Diego; Session Title: AKI: New Players and New Mechanisms,
October 25th from 18:00 PT (session room 6D).

Erik van den Berg, CEO of AM-Pharma said: “We are excited to share the
clinical trial results in JAMA and scientific conferences. We are now
preparing for the pivotal study to confirm the STOP-AKI study results,
which could have a significant impact on patients with Acute Kidney
Injury, for whom there is currently no treatment available.”

Previously, the US Food and Drug Administration granted Fast Track
designation for recAP for treatment of sepsis-associated AKI. AKI
involves inflammatory processes in the kidney which can lead to complete
loss of renal function and is associated with high mortality rates.

Notes to Editors

About AM-Pharma
is a biopharmaceutical company focused on the development of recAP
(recombinant Human Alkaline Phosphatase) for treatment of Acute Kidney
Injury (AKI), Ulcerative Colitis (UC), Necrotizing Enterocolitis (NEC)
and Hypophosphatasia (HPP). Based on strong results from Phase II trials
with bovine Alkaline Phosphatase in AKI and UC, AM?Pharma has developed
an innovative recombinant form of human Alkaline Phosphatase (recAP),
and recently completed recruitment of 301 patients in the STOP-AKI
adaptive Phase II trial for sepsis-associated AKI.

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 require dialysis have the worst prognosis.
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 guidance by

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.

About STOP-AKI study
The trial, titled A Safety,
Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of
Patients With SA-AKI (STOP-AKI), is an adaptive Phase II trial with two
parts. In the first part, data from 120 patients were evaluated to
select the most effective dose of recAP. In the second part, an
additional 170 patients were recruited into two arms, receiving either
the optimal dose of recAP identified initially, or placebo. The study
recruited 301 patients in total, which makes it the largest
interventional clinical study iwan AKI to date. The study was conducted
in more than 50 intensive care units (ICU) in Western Europe and North
America. (click here
for full details on the protocol).

1 U.S. Food and Drug Administration; available at

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

Chertow et al., (2005) J Am Soc Nephrol. Vol 16: 3365-3370 Soc Nephrol.
Vol 16: 3365-3370

– ENDS –


Company contact:
Erik van den Berg
+31 30 259 8838
Media contact:

Adam Michael
+44 1223 511338
+44 777 588 1813

Source: AM-Pharma

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