DP-b99 promising for acute high-risk pancreatitis

Results from a phase 2 pilot study showed DP-b99 was safe and well-tolerated in patients with acute high-risk pancreatitis and may lower inflammatory markers, the manufacturer announced.

DP-b99 (D-Pharm) “interferes with several fundamental pathological processes relevant for pancreatitis such as inappropriate calcium-initiated intracellular activation of proteolytic enzymes in acinar cells and activation of trypsinogen to trypsin, which cause pancreatic tissue damage,” according to a press release. “Another aspect of DP-b99 action is the drug’s ability to modulate generation of pro-inflammatory cytokines which apparently play a pivotal role both in the pathogenesis of acute pancreatitis and its systemic complications.”

Researchers performed a double-blind trial involving 10 pancreatitis patients who were randomly assigned to receive DP-b99 administered intravenously twice-per-day or placebo for 2 days at a number of clinical sites in the Czech Republic, Ukraine and Slovakia, the release said. While the study was intended to enroll 30 patients, enrollment was stopped early due to a slow enrollment rate, and efficacy analyses were not conducted because of the small cohort.

The results showed DP-b99 was safe and well-tolerated, and patients in the treatment arm had lower C-reactive protein and matrix metallopeptidase on average compared with controls. This was the first clinical study evaluating DP-b99 in patients with acute high-risk pancreatitis, according to the release. Previous studies also demonstrated a good safety profile for DP-b99, with a total of 466 patients and healthy controls having received the drug to date.