— Successfully completes Phase 1 clinical studies— Initiated dosing of first Type 2 diabetic patients in chronic Phase 2 study
MINNEAPOLIS, MN, USA I January 9, 2014 I DiaMedica (TSX VENTURE:DMA), a clinical stage biopharmaceutical company announced today it has met the primary endpoints of safety and tolerability from the recently completed 16-day Phase 1 multiple ascending dose (MAD) of DM199 in healthy volunteers. DiaMedica has also initiated dosing of the first Type 2 diabetic patients in a one-month DM199 Phase 2 clinical trial. DM199 is a recombinant human tissue kallikrein-1 (rhKLK-1) protein and a novel treatment for diabetes and its complications by targeting the Kallikrein-Kinin System.
“We are very pleased to have completed our 16 day Phase 1 study and have the first patients started on treatment in our chronic Phase 2 clinical program of DM199 in Type 2 diabetic patients,” stated Rick Pauls, Chairman & CEO for DiaMedica. “DM199 is based on a naturally occurring protein and has the potential to treat Type 2 diabetes, control blood pressure and improve kidney function.”
In the recently completed Phase 1 MAD clinical trial of 18 healthy volunteers, DM199 was well-tolerated at all three dose levels and met the primary endpoints of safety and tolerability. DM199 also demonstrated a favorable pharmacokinetic profile supporting the potential for weekly dosing.
Based on the Phase 1 clinical results, DiaMedica has initiated a Phase 2 clinical study in patients with Type 2 diabetes to evaluate the safety, tolerability and pharmacokinetics of two dose levels of DM199 and its effects on diabetes biomarkers including: HOMA2-IR, fasting glucose and plasma insulin, meal tolerance test, lipids, HbA1c and other metabolic markers. The one-month, randomized, double-blinded, placebo-controlled study is expected to enroll 36 patients with Type 2 diabetes. The patients will start with a one-month wash out of their diabetes mediations and then be sequestered for the one-month study.
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, DM199, is a recombinant human protein known as rhKLK1 that represents a novel approach to treating diabetes and associated complications. DiaMedica is also developing a novel monoclonal antibody, DM204 for the treatment of Type 2 diabetes, which is in preclinical development.
SOURCE: DiaMedica
Post Views: 588
— Successfully completes Phase 1 clinical studies— Initiated dosing of first Type 2 diabetic patients in chronic Phase 2 study
MINNEAPOLIS, MN, USA I January 9, 2014 I DiaMedica (TSX VENTURE:DMA), a clinical stage biopharmaceutical company announced today it has met the primary endpoints of safety and tolerability from the recently completed 16-day Phase 1 multiple ascending dose (MAD) of DM199 in healthy volunteers. DiaMedica has also initiated dosing of the first Type 2 diabetic patients in a one-month DM199 Phase 2 clinical trial. DM199 is a recombinant human tissue kallikrein-1 (rhKLK-1) protein and a novel treatment for diabetes and its complications by targeting the Kallikrein-Kinin System.
“We are very pleased to have completed our 16 day Phase 1 study and have the first patients started on treatment in our chronic Phase 2 clinical program of DM199 in Type 2 diabetic patients,” stated Rick Pauls, Chairman & CEO for DiaMedica. “DM199 is based on a naturally occurring protein and has the potential to treat Type 2 diabetes, control blood pressure and improve kidney function.”
In the recently completed Phase 1 MAD clinical trial of 18 healthy volunteers, DM199 was well-tolerated at all three dose levels and met the primary endpoints of safety and tolerability. DM199 also demonstrated a favorable pharmacokinetic profile supporting the potential for weekly dosing.
Based on the Phase 1 clinical results, DiaMedica has initiated a Phase 2 clinical study in patients with Type 2 diabetes to evaluate the safety, tolerability and pharmacokinetics of two dose levels of DM199 and its effects on diabetes biomarkers including: HOMA2-IR, fasting glucose and plasma insulin, meal tolerance test, lipids, HbA1c and other metabolic markers. The one-month, randomized, double-blinded, placebo-controlled study is expected to enroll 36 patients with Type 2 diabetes. The patients will start with a one-month wash out of their diabetes mediations and then be sequestered for the one-month study.
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, DM199, is a recombinant human protein known as rhKLK1 that represents a novel approach to treating diabetes and associated complications. DiaMedica is also developing a novel monoclonal antibody, DM204 for the treatment of Type 2 diabetes, which is in preclinical development.
SOURCE: DiaMedica
Post Views: 588
