D-Pharm announces recruitment of the first patient into its Phase 2 clinical trial with DP-b99 in acute high-risk pancreatitis
D-Pharm Ltd (TASE:DPRM) announced today January 14th 2014, that the first patient has been recruited into its Phase 2 clinical trial of DP-b99 in patients with acute high-risk inflammation of the pancreas (pancreatitis). DP-b99 is a first-in-class cell protective drug that addresses multiple mechanisms damaging to insulted cells.
This double-blind, placebo-controlled, multicenter study is examining for the first time DP-b99’s efficacy in patients with acute pancreatitis. The study is enrolling thirty patients to be treated, twice daily for 2 days, with either DP-b99 or placebo. The follow-up involves clinical assessment scales, monitoring of inflammatory biomarkers and abdominal imaging.
The current development for pancreatitis builds on the extensive clinical safety database, pre-clinical research, as well as the CMC package of DP-b99, accepted in the past both by the FDA and EMA. DP-b99 has, so far, been safely administered to over 450 stroke patients and healthy volunteers; preclinical and clinical studies all indicate a favorable safety profile. Dr. Gilad Rosenberg, D-Pharm’s VP of Clinical Development commented: “There is currently no effective specific treatment for acute pancreatitis, and patients only receive symptomatic therapy. The lack of specific therapy is particularly problematic in those patients who are at an increased risk of developing acute severe pancreatitis, a condition associated with multiple complications and a high risk of mortality. DP-b99 has the potential to help these high-risk patients by altering the course of the disease thus addressing this significant unmet medical need”.
In the US acute pancreatitis has an incidence of approximately 40 cases per year per 100,000 adults. Approximately 20% of patients with acute pancreatitis develop severe acute pancreatitis. 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. 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.
D-Pharm (www.dpharm.com) is a clinical stage, technology-driven biopharmaceutical company developing proprietary products for treatment of CNS disorders. D-Pharm’s pipeline includes clinical Phase 2 products, as well as a rich preclinical development pipeline for Alzheimer's disease, and other types of dementia. The clinical program for DP-b99 in acute severe pancreatitis is the second Phase 2 clinical program that D-Pharm initiated in 2013; the first being a Phase 2 study with THR-18 in acute stroke patients treated with tissue plasminogen activator (tPA).
Posted: January 2014