Winnipeg - Medicure Inc. (TSX: MPH; AMEX: MCU), a cardiovascular drug discovery and development company, reported that its MC-4232 met primary blood pressure and metabolic endpoints in their Phase II MATCHED study. The study evaluated MC-4232, a combination of MC-1 and the ACE inhibitor, lisinopril, in the treatment of coexisting diabetes and hypertension. Based on these positive results, the company plans to move forward with a pivotal Phase III clinical development program for MC-4232.
"The trial has exceeded our expectations, demonstrating the clinical benefits of MC-4232," commented Medicure's President and CEO, Albert D. Friesen, PhD. "We believe the evidence presents a unique development opportunity, advancing a novel product with combined blood pressure and multiple metabolic benefits for a patient population in desperate need for improved treatment in both areas. We are now advancing MC-4232 into Phase III pivotal studies and these results set the stage for the development of other cardiovascular combination products."
The results of MATCHED demonstrated the positive clinical effects of MC-4232 on primary and secondary blood pressure endpoints, including both systolic and diastolic measurements: The 300mg/20mg (MC-1/lisinopril) dose of MC-4232 had a statistically significant reduction of 12.0 mmHg from baseline over eight weeks on the primary endpoint of mean daytime ambulatory systolic blood pressure (MDASBP).
The 300mg/20mg dose reduced MDASBP by 12.0 mmHg over eight weeks as compared to a 7.5 mmHg reduction with lisinopril alone, demonstrating the improved antihypertensive effects of MC-4232 over lisinopril alone.
In the secondary endpoint of reduction in MDADBP, the 300mg/20mg dose of MC-4232 reduced MDADBP by 7.5 mmHg over eight weeks as compared to a 4.1 mmHg reduction with lisinopril alone, again demonstrating the improved antihypertensive effects of MC-4232 over lisinopril alone.
The results of MATCHED also demonstrated the positive clinical effects of MC-4232 on primary and secondary metabolic endpoints, including glycemic control as measured by fasting serum glucose and glycated hemoglobin (HbAIc), as well as lipid control, after 16 weeks of treatment.
"While medical guidelines recommend stringent blood pressure targets for diabetic patients, such as those studied in the MATCHED trial, achieving and maintaining these targets has proven to be extremely difficult. Although all classes of antihypertensive agents are effective at lowering blood pressure in diabetic patients, treatment has been further complicated by the fact that some major classes have been shown to have deleterious effects on glycemic control," the principal investigator of the study, Yves Lacourciere MD, FRCP, FACP, said. "The results demonstrate that MC-4232 not only provides clinically important blood pressure reduction beyond that of lisinopril alone, but also improves upon the glycemic and lipid control offered by current therapies. Based on this data, I believe MC-4232 could be an innovative new treatment that in addition to significant blood pressure reduction also offers metabolic benefits to patients with coexisting diabetes and hypertension."
The MATCHED study (MC-1 and ACE Therapeutic Combination for Hypertensive Diabetics) was designed as a Phase II trial to determine the optimal dose and endpoint for Phase III development of MC-4232. MATCHED was a randomized, parallel group, cross-over, double-blind, placebo-controlled comparison of 100, 300 or 1000 mg of MC-1 alone and in combination with 20 mg of lisinopril. The study results are based on a population of 120 patients with coexisting type II diabetes and hypertension from 12 sites across Canada. In order to minimize the carryover effects of lisinopril, all patients were randomized in two different treatment sequences. Patients randomized in the first treatment sequence received an eight-week treatment with MC-4232 (20 mg of lisinopril and MC-1) or placebo and then an 8-week treatment with MC-1 alone or placebo. Patients randomized in the second treatment sequence received an 8-week treatment with MC-1 alone or placebo and then an 8-week treatment with MC-4232 or placebo. In each treatment sequence, all patients were randomized to MC-1 at one of the three prespecified dosages.
This trial was conducted under the guidance and direction of the internationally recognized hypertension specialist, Yves Lacourciere, Director of the Hypertension Research Unit, Centre Hospitalier de l'Universite Lavai Sainte-Foy, Quebec. Dr. Lacourciere, one of North America's foremost experts in management of hypertension in difficult to treat patient groups, led a group of specialist investigators who enrolled patients at sites across Canada. Dr. Lacourciere has led numerous important hypertension studies and serves as a scientific advisor to several leading pharmaceutical companies.
Medicure is focused on developing effective therapeutics for unmet needs in the field of cardiovascular medicine, the largest pharmaceutical market sector. The company has two drugs - MC-1 & MC-4232 - in advanced clinical development with three positive Phase II trials already completed.
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