Completes First in Human Escalating Dose Study in Healthy Volunteers with DM-199 – Demonstrates Favorable PK Profile Potentially Supporting Once a Week Dosing – Initiates Dosing in Type 2 Diabetic Patients with DM-199
MINNEAPOLIS, MN, USA I June 24, 2013 I DiaMedica (TSX VENTURE:DMA), a clinical stage biopharmaceutical company, today provided an update on the ongoing clinical trial program for DM-199, its novel biopharmaceutical in clinical development for the treatment of diabetes and associated complications. The company completed the first portion of its ongoing phase I/II study of DM-199 in healthy volunteers and has now initiated dosing of DM-199 in Type 2 diabetes patients.
“Our development program is on track as we successfully completed acute escalating dosing of DM-199 at multiple levels in healthy volunteers. We are now advancing the program to evaluate the acute effects of escalating doses of DM-199 in patients with Type 2 diabetes,” said Dr. Mark Robbins, Vice President of Clinical and Regulatory Affairs at DiaMedica. “Further, preliminary results from the first part of the study in 18 healthy volunteers show that DM-199 was well tolerated and demonstrated a favorable pharmacokinetic profile, supporting potential once weekly dosing.”
The randomized, placebo-controlled, double-blinded study has now enrolled Type 2 diabetic patients to evaluate three well-tolerated dose levels based upon data from the first portion in healthy volunteers. This second portion of the study will evaluate acute safety, tolerability and pharmacokinetic properties for the first time in Type 2 diabetic patients, as well as the effect of DM-199 on improving glucose control.
About DM-199
DM-199 is a novel recombinant human protein known as tissue kallikrein-1 (rhKLK-1) and is currently in clinical development as a potential treatment for Type 1 and Type 2 diabetes and associated diabetic complications. DM-199 is believed to restore the body’s regulation of four key areas disrupted in diabetes: increasing insulin sensitivity; improving insulin secretion; improving blood flow and immunomodulation. Through this natural physiological mechanism, DM-199 represents a novel approach for improving glucose control and reducing associated complications in diabetic patients.
About DiaMedica
DiaMedica Inc. is a publicly traded (TSX VENTURE:DMA) 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 clinical stage compound, DM-199, is a recombinant human protein that represents a novel approach to treating Type 1 and Type 2 diabetes. DiaMedica is also developing a novel monoclonal antibody, DM-204 for the treatment of Type 2 diabetes, which is in preclinical development.
SOURCE: DiaMedica
Post Views: 108
Completes First in Human Escalating Dose Study in Healthy Volunteers with DM-199 – Demonstrates Favorable PK Profile Potentially Supporting Once a Week Dosing – Initiates Dosing in Type 2 Diabetic Patients with DM-199
MINNEAPOLIS, MN, USA I June 24, 2013 I DiaMedica (TSX VENTURE:DMA), a clinical stage biopharmaceutical company, today provided an update on the ongoing clinical trial program for DM-199, its novel biopharmaceutical in clinical development for the treatment of diabetes and associated complications. The company completed the first portion of its ongoing phase I/II study of DM-199 in healthy volunteers and has now initiated dosing of DM-199 in Type 2 diabetes patients.
“Our development program is on track as we successfully completed acute escalating dosing of DM-199 at multiple levels in healthy volunteers. We are now advancing the program to evaluate the acute effects of escalating doses of DM-199 in patients with Type 2 diabetes,” said Dr. Mark Robbins, Vice President of Clinical and Regulatory Affairs at DiaMedica. “Further, preliminary results from the first part of the study in 18 healthy volunteers show that DM-199 was well tolerated and demonstrated a favorable pharmacokinetic profile, supporting potential once weekly dosing.”
The randomized, placebo-controlled, double-blinded study has now enrolled Type 2 diabetic patients to evaluate three well-tolerated dose levels based upon data from the first portion in healthy volunteers. This second portion of the study will evaluate acute safety, tolerability and pharmacokinetic properties for the first time in Type 2 diabetic patients, as well as the effect of DM-199 on improving glucose control.
About DM-199
DM-199 is a novel recombinant human protein known as tissue kallikrein-1 (rhKLK-1) and is currently in clinical development as a potential treatment for Type 1 and Type 2 diabetes and associated diabetic complications. DM-199 is believed to restore the body’s regulation of four key areas disrupted in diabetes: increasing insulin sensitivity; improving insulin secretion; improving blood flow and immunomodulation. Through this natural physiological mechanism, DM-199 represents a novel approach for improving glucose control and reducing associated complications in diabetic patients.
About DiaMedica
DiaMedica Inc. is a publicly traded (TSX VENTURE:DMA) 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 clinical stage compound, DM-199, is a recombinant human protein that represents a novel approach to treating Type 1 and Type 2 diabetes. DiaMedica is also developing a novel monoclonal antibody, DM-204 for the treatment of Type 2 diabetes, which is in preclinical development.
SOURCE: DiaMedica
Post Views: 108
