D-Pharm Ltd has received approval from the regulatory authorities in Slovakia to begin a phase II clinical study to explore the utility of DP-b99 in patients with acute high-risk inflammation of the pancreas (pancreatitis).
The planned study in patients with acute pancreatitis is a double-blind, placebo-controlled, multicentre trial. Thirty patients will be treated twice daily for two days, with either DP-b99 or placebo and followed up using clinical assessment scales, by monitoring inflammatory biomarkers and with abdominal imaging.
Preclinical and clinical studies indicate a favorable safety profile of the drug. So far, DP-b99 been safely administered to 456 patients and healthy volunteers.
Dr Alex Kozak, D-Pharm’s CEO and founder commented: “I am thrilled by the progress of D-Pharm’s clinical programmes. This is already the third clinical protocol approved for our products in 2013. Current development of DP-b99 for pancreatitis will capitalize on the extensive DP-b99 database accepted in the past by the FDA and EMA for testing the drug in acute ischemic stroke patients. This is a great opportunity. Our belief in this home grown product to help seriously ill patients remains unshaken. We’re delighted that DP-b99 is, once again, being tested in patients and we eagerly await the outcome of this study.”
DP-b99 interferes with several fundamental pathological processes, relevant for a wide range of conditions, via modulation of a range of metal dependent enzymes involved in the cell death cascade and inflammation. DP-b99 is a first-in-class drug addressing multiple mechanisms of cell damage and thus provides a comprehensive approach to protection of insulted cells. Results from studies in in vitro and in vivo models of pancreatitis suggest that DP-b99 can suppress some severe detrimental processes associated with the disease.
Acute pancreatitis necessitates hospitalization in an intensive care unit and in severe cases mortality may reach 20 per cent. In the US there are around 20 cases of acute pancreatitis per year per 100,000 of population and survivors frequently suffer long term disability. There is no effective specific treatment for acute severe pancreatitis.
D-Pharm is a clinical stage, technology-driven biopharmaceutical company developing proprietary products for treatment of CNS disorders.