Utrecht, The Netherlands – AM-Pharma B.V., a biopharmaceutical company focused on the development of recombinant human Alkaline Phosphatase (recAP) for inflammatory diseases, today announced positive results from its adaptive Phase II study in 301 sepsis patients with Acute Kidney Injury (AKI), the largest therapeutic study in AKI to date.
The STOP-AKI study demonstrated a significant and dose-dependent relative reduction in mortality of more than 40% in the treatment group compared to the placebo group. While the addition of recAP to the standard of care did not affect kidney function in the first week of the study (the primary endpoint), it did show a significant, progressive and sustained improvement in renal function over the 28-day study period. Throughout the study, safety data were regularly reviewed by an independent Data Safety Monitoring Board (DSMB), without any observations of concern.
Previously, the US Food and Drug Administration granted Fast Track designation to recAP for the treatment of sepsis-associated acute kidney injury. Acute Kidney Injury involves inflammatory processes in the kidney which can lead to complete loss of renal function and is associated with high mortality rates.
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), 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. 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. For more information, visit the company’s website at www.am-pharma.com
About Gilde Healthcare
Gilde Healthcare is a specialized European healthcare investor managing two business lines: a venture & growth capital fund and a lower mid-market buy-out fund. Gilde Healthcare’s venture & growth capital fund invests in medtech, diagnostics, digital health and therapeutics. The portfolio companies are based in Europe and North America. Gilde Healthcare’s lower mid-market buy-out fund invests in profitable European healthcare services companies with a focus on the Benelux and Dach-region. The portfolio consists of healthcare providers, suppliers of medical products and other service providers in the healthcare market. Since 2001 Gilde Healthcare has raised €800 million ($1 billion) for its specialized funds. For more information, visit the company’s website at www.gildehealthcare.com