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Trials & Filings

D-Pharm Recruits First Pancreatitis Patient

Ph II study to involve 30 patients

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

D-Pharm Ltd. has recruited the first patient for its Phase II 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 30 patients to be treated, twice daily for two days, with either DP-b99 or placebo. The follow-up involves clinical assessment scales, monitoring of inflammatory biomarkers and abdominal imaging.

The current development program for pancreatitis builds on the clinical safety database, preclinical research, and CMC package of DP-b99, which has been accepted by the FDA and EMA. DP-b99 has, so far, been safely administered to more than 450 stroke patients and healthy volunteers; preclinical and clinical studies all indicate a favorable safety profile.

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