Developing disease modifying Alkaline Phosphatase therapeutics.
AM–Pharma is a biopharmaceutical company developing proprietary recombinant human Alkaline Phosphatase (AP) therapeutics, which have the potential to transform the treatment prospects for patients with Acute Kidney Injury, Inflammatory Bowel Disease and Hypophosphatasia.
Previously, the company developed and successfully tested a bovine form of AP in three phase II trials in patients with sepsis, AKI and UC.
AM-Pharma has since developed and manufactured a proprietary and fully human recombinant form of AP, known as recAP. In a Phase I study in healthy volunteers recAP showed a clean safety profile and favorable pharmacological properties.
In 2018 the company completed a Phase IIb trial in patients diagnosed with sepsis-associated acute kidney injury (SA-AKI). With an estimated two million AKI patients in the western world, no current treatments available, and an estimated 10 billion dollar healthcare cost for AKI supportive care in the US, a therapy would be very welcome.
Market Need
Acute Kidney Injury is an acute inflammation of the kidney, which results in kidney damage and a rapid loss of kidney function and often leads to dialysis. There are currently no approved drugs for disease treatment. Read more.
Inflammatory Bowel Disease is a group of inflammatory conditions of the colon and small intestine. The major types include Crohn's disease and Ulcerative Colitis. There are two biologics approved for treating ulcerative colitis, but there remains a clear need for a therapy that is both safe, efficacious over time and convenient to use. Read more.