DiaMedica Receives Phase I/II Clinical Trial Regulatory Approval for DM-199 as a Potential Treatment for Diabetes
- Category: Proteins and Peptides
- Published on Monday, 08 April 2013 18:27
- Hits: 512
MINNEAPOLIS, MN, USA I April 8, 2013 I DiaMedica (TSX VENTURE:DMA), is pleased to announce it has received regulatory approval to commence an anticipated 76 subject Phase I/II clinical trial for DM-199. The clinical trial, to be conducted in the Netherlands, is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of DM-199 in 36 healthy volunteers and in 40 T2D patients. Data from this trial will also support future DM-199 clinical trial regulatory filings for Type 1 and 2 diabetes and in other potential indications.
"We look forward to commencing the DM-199 clinical trial," stated Mr. Rick Pauls, Chairman & CEO, DiaMedica. "Based on pre-clinical results showing a novel dual mechanism of action (insulin sensitizer and insulin secretagogue) that improves glucose control and blood pressure, we have high hopes for this drug in improving the lives of diabetes patients."
The Phase I stage, a randomized, controlled trial to evaluate the safety, tolerability and pharmacokinetics of DM-199 in healthy volunteers, consists of both single ascending dose arms, and in multiple ascending dose for 14 days arms to assess the maximum tolerable dose. In the Phase II stage, T2D patients will initially be assessed for acute safety and efficacy in single ascending dose study via a meal tolerance test. A follow on 28-day dosing double-blinded placebo-controlled to assess the efficacy and safety of longer term DM-199 use. Efficacy endpoints will include measuring HbA1c, post-meal blood glucose, average blood glucose and glucose regulatory peptides levels over the 28-day study period.
DiaMedica Inc. (TSX VENTURE:DMA) is a clinical stage biopharmaceutical company focused on the discovery and development of novel therapies to treat diabetes and the complications associated with diabetes. DiaMedica's lead compound, DM-199, is a recombinant human protein that represents a novel approach to treating Type 1 and Type 2 diabetes. Based on the Company's understanding of the postprandial state, DiaMedica is also developing a novel monoclonal antibody, DM-204 for the treatment of Type 2 diabetes. Chronic treatment with DM-204 in a pre-clinical Type 2 diabetes model resulted in a significant improvement in blood glucose control as measured by HbA1c and also significant improved blood pressure and serum cholesterol levels.