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AM-Pharma presents positive results for Phase II trial in Acute Kidney Injury

AM-Pharma presents positive Phase II results for potential First-In-Class drug

AM-Pharma presents positive results of its Phase II clinical trial with Alkaline Phosphatase in Acute Kidney Injury at the ISICEM conference in Brussels Alkaline Phosphatase improved renal function, reduced length of stay in Intensive Care, and could become First-in-Class drug in multi-billion market

Bunnik, The Netherlands, 10 March 2010. AM-Pharma B.V., the biopharmaceutical company, today announced positive results from its Phase II Acute Kidney Injury trial with Alkaline Phosphatase at ISICEM, one of the world’s leading Intensive Care conferences. The study showed that treatment of Acute Kidney Injury (AKI) with Alkaline Phosphatase results in improved renal function and reduced length of stay in Intensive Care. No drug currently exists to treat AKI, therefore Alkaline Phosphatase could become a “first in class” product in the market. The cost of managing AKI in the US is around $10 billion per year.

The key objective of the trial was to show improved kidney function in AKI patients treated with bovine Alkaline Phosphatase. Primary efficacy parameters were; dialysis requirement, creatinine clearance and serum creatinine. The trial objective was met and the results are both statistically significant and clinically relevant. The treatment was well tolerated and there were no safety concerns.

Statistical significant improvement was also reached on important secondary endpoints. Average stay in Intensive Care was significantly shorter for patients on Alkaline Phosphatase compared to patients on placebo. Also, the need for mechanical ventilation was significantly reduced.

In this double blind, placebo controlled, prospective clinical study in 36 patients with AKI secondary to sepsis, patients received Alkaline Phosphatase intravenously for 48 hours and were followed for 28 days. The multi-centre trial was conducted at critical care units in The Netherlands and Belgium.

A composite analysis of all primary renal function efficacy parameters, creatinine clearance, serum creatinine and dialysis requirement shows statistically significant improvement (p=0.005) compared to placebo. Renal creatinine clearance improved more than twice as fast in the treated group during the first 7 days, (p<0.02) resulting in normalization of creatinine clearance for the rest of the 28 days, compared to the placebo group, where creatinine clearance remained impaired (p<0.02). There was a reduction of dialysis requirement after treatment with Alkaline Phosphatase compared to placebo (means: 10 hours vs 53 hours, p=0.08). Treatment with Alkaline Phosphatase resulted in shorter stay in ICU (11 days vs 25 days, p<0.02) and in reduced need for mechanical ventilation (3.9 days vs 6.0 days, p<0.03). Patients in the group treated with Alkaline Phosphatase were comparable at baseline to patients in the placebo group.

These results confirm the results of an earlier Phase II trial with bovine Alkaline Phosphatase in a similar patient population. The results of this first trial were published in Critical Care Medicine journal in February 2009.

Bart Wuurman, CEO commented: “With the results of our two trials we have shown convincingly that Alkaline Phosphatase is very promising as a safe and effective treatment of Acute Kidney Injury. Motivated by these positive results with bovine Alkaline Phosphatase, we are now switching to our proprietary recombinant human Alkaline Phosphatase for further development and commercialization. It is very exciting to be progressing with this novel drug, which could be the first treatment to be approved for Acute Kidney Injury, a condition with high incidence, high mortality and high cost burden to our healthcare system”.

AM-Pharma has now reported positive results with Alkaline Phosphatase in three Phase II clinical trials. In the two AKI trials Alkaline Phosphatase was given intravenously and in a third Phase II trial with Alkaline Phosphatase in severe Ulcerative Colitis, the drug was administered orally.


Notes to editors:

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 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%. Annually, the deaths of around 700,000 patients in Europe, US and Japan are related to AKI. In the US alone, around $10 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. The incidence is increasing because of an aging population, an increasing exposure to nephrotoxic drugs in hospitals, increasing number of surgical interventions and an increasing incidence of hospital infections. An effective drug to treat AKI could be commercially very important. Because of the large number of patients suffering from AKI, the high medical need and the lack of competitors, worldwide annual sales of over $2 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 gastro-intestinal tract, kidney, liver and lungs. An important role of AP is the dephosphorylation of pro-inflammatory agents like lipopolysacharides (LPS) and extra-cellular ATP. During Acute kidney Injury, which involves a localized inflammatory process, locally present AP is rapidly depleted. AM-Pharma has shown that treatment with exogenous AP can reduce local inflammation and protect the kidney against further damage.

About AM-Pharma<> AM-Pharma is a biopharmaceutical company focused on the preclinical and clinical development of Alkaline Phosphatase as treatment of severe inflammatory diseases. AM-Pharma is based in Bunnik, The Netherlands with a staff of 9. The company is financed by Forbion Capital Partners and Inventages Venture Capital. Motivated by the positive results of the Phase II trials with bovine Alkaline Phosphatase in Acute Kidney Injury and a Phase II trial in severe Ulcerative Colitis, AM-Pharma will replace bovine Alkaline Phosphatase with its proprietary recombinant form of enhanced human Alkaline Phosphatase. This recombinant material will be used in future trials and for commercialization. AM-Pharma is currently raising funds to finance the switch to recombinant human Alkaline Phosphatase. Now that safety and efficacy have been established with Alkaline Phosphatase in three Phase II trials, AM-Pharma is looking to partner with pharmaceutical companies for further development and world wide marketing. For further information, please contact College Hill Life Sciences Adam Michael / Justine Lamond Tel: +44 (0)20 7866 7857

AM-Pharma CEO Bart Wuurman Tel: +31 (0)30 2289222

Posted: March 2010