AM-Pharma announces positive results from its Acute Kidney Injury trial
Positive Phase II trial results confirm observations from earlier Acute Kidney Injury trial
Bunnik, The Netherlands, 17 December 2009: AM-Pharma B.V., the biopharmaceutical company, today announced positive results from its Phase II Acute Kidney Injury trial with Alkaline Phosphatase. AM-Pharma showed statistically significant improvement on the primary clinical endpoint and on several secondary endpoints after interim analysis of the treatment effect on 26 patients.
The primary objective of the trial was to show improved kidney function in Acute Kidney Injury patients treated with bovine Alkaline Phosphatase, measured by reduced serum creatinine, the standard indicator of kidney function. In patients treated with the drug, serum creatinine reduced faster over a 28 day period, compared to patients receiving placebo. The results are both statistically significant and clinically relevant.
Statistical significant improvement was also reached on several secondary endpoints. Average stay in Intensive Care and in hospital was much shorter for patients on Alkaline Phosphatase compared to patients on placebo. Also, SOFA scores, a measure of the function of six vital organ systems, which is correlated to survival of patients, improved significantly.
Positive trends and clinically relevant treatment effects were observed in creatinine clearance and in reduction of dialysis requirement. The treatment was very well tolerated and there were no safety concerns.
In this double blind, placebo controlled, prospective clinical study in patients with Acute Kidney Injury secondary to sepsis, patients received Alkaline Phosphatase intravenously for 48 hours. The trial was conducted at critical care units in The Netherlands and Belgium. The full results will be presented in March 2010, at ISICEM in Brussels, one of the world’s leading Intensive Care conferences.
These results confirm and strengthen the results of an earlier Phase II trial with bovine Alkaline Phosphatase in a similar patient population. The results of this first trial were reported by AM-Pharma in 2007 and published in Critical Care Medicine journal in February 2009.
Bart Wuurman, CEO commented: “We now have convincingly shown that Alkaline Phosphatase has great potential as a safe and effective treatment of Acute Kidney Injury. We are delighted to see statistically significant improvement on our primary endpoint already with 26 patients, which is a clear proof of the potency of our drug. 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 and high associated mortality”.
AM-Pharma has now reported positive results with Alkaline Phosphatase in three Phase II clinical trials. In the two Acute Kidney Injury 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 Hospital-acquired Acute Kidney Injury occurs in as many as 4% of hospital admissions and 20% of critical care admissions. The incidence is increasing because of an aging population, an increasing exposure to nephrotoxic drugs in hospitals, increasing number of surgical interventions and increasing hospital infections. Depending on the severity of renal injury, the mortality rate ranges from 7% to as high as 40%. Annually around 700,000 patients die of Acute Kidney Injury in Europe, US and Japan. Currently the only treatment options are dialysis and supportive care. No drugs are approved to treat this condition.
About AM-Pharma www.am-pharma.com<http://www.am-pharma.com/> 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. As a consequence of the positive results of the trials with bovine Alkaline Phosphatase in Acute Kidney Injury and of 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. Now that safety and efficacy have been established with Alkaline Phosphatase in three Phase II trials, AM-Pharma intends to out-license its products to one or more larger pharmaceutical companies for further development and world wide marketing. For further information, please contact:
College Hill Life Sciences Benjamyn Tan / Adam Michael Tel: +44 (0)20 7866 7855 firstname.lastname@example.org
AM-Pharma CEO Bart Wuurman Tel: +31 (0)30 2289227 www.am-pharma.com
Posted: December 2009