MONTREAL--(BUSINESS WIRE)--Thrasos Therapeutics, a biotherapeutics company focused on delivering new solutions for kidney disease, announced the completion of enrollment in its Phase 2 clinical study of THR-184 for the prevention of acute kidney injury (AKI) in “at risk” patients undergoing cardiac surgery. Results from the 452-patient study are expected by January 2016.
The objective of the study is to evaluate the safety of THR-184 as well as the potential for THR-184 to prevent AKI associated with cardiac surgery in patients with known risk factors for AKI such as age, diabetes, underlying chronic kidney disease and heart failure. In this study THR-184 or placebo was administered both prior to surgery and after surgery. Thrasos began its Phase 2 clinical study in late 2013 and has worked closely with its Canadian Clinical Research Organization (CRO) - The Montreal Health Innovations Coordinating Center (MHICC), its US CRO - Clinical Trial and Consulting (CTI), its biostatistics and data management CRO - Cytel and 40 leading cardiac surgery centers in the United States and Canada to execute the study.
The study employed an adaptive design. In the first stage of the study, three doses were tested and compared to placebo. All assessments were blinded and only made available to the Independent Data Monitoring Committee (IDMC). The IDMC conducted a formal interim analysis under a futility standard in August 2014 at which time it recommended that the Company continue with the highest dose arm. In addition, upon consultation with the Steering Committee, the Company added an additional high dose arm at that time so that the trial now includes two different high dose arms and a placebo arm. The details of the trial can be found at clinicaltrials.gov.
“We are committed to improving the lives of kidney disease patients, and are pleased to have completed enrollment in this significant Phase 2 study,” said Richard Andrews President and CEO of Thrasos Therapeutics. “Cardiac surgery is a leading cause of AKI, which can lead to a persistent decline in kidney function, and is associated with longer hospital stays, and increased mortality. One in five hospitalized adult patients can experience AKI, and the incidence can be as high as one in two for the at risk population. Completing enrollment in this study is an important step in the development of THR-184 and in bringing forward a new solution for the treatment and prevention of AKI.”
“This large, important study targets a group of patients with few treatment options, and we are eager to see if THR-184 will prevent the development of acute kidney injury for patients undergoing cardiac surgery,” stated Jonathan Himmelfarb, MD, Professor of Medicine Director, Kidney Research Institute, at the University of Washington.
THR-184 is a proprietary peptide that acts on the BMP/Smad pathway. Results from a broad set of preclinical studies showed THR-184 had protective effects in animal models of AKI, and in two Phase 1 clinical trials THR-184 was found to be safe and well-tolerated. The Phase 2 study successfully passed a formal interim futility analysis, and THR-184 has been granted Fast Track designation for the prevention of AKI following cardiac surgery by the U.S. Food and Drug Administration (FDA).
About Acute Kidney Injury (AKI)
AKI is the sudden loss of kidney function, and it affects more than 1.2 million people each year in the United States. It occurs in different situations and is particularly frequent in patients hospitalized for major surgery, including cardiac and/or vascular surgery, trauma, infection, cardiac disease or cancer. AKI can lead to permanent reduction of kidney function and is also associated with an increased risk of death, extended hospitalization and significantly increased medical cost. There are currently no available therapies to prevent or treat AKI.
Thrasos is a privately held, clinical-stage biotherapeutics company focused on delivering new solutions to individuals affected by kidney disease. The company’s lead compound, THR-184, is currently being evaluated in a Phase 2 clinical study for the prevention of Acute Kidney Injury (AKI) in patients undergoing cardiac surgery. The company believes that its technology will be broadly applicable to other types of major surgery where AKI is also a significant complication. Thrasos is also developing a compound for diabetic nephropathy, a major cause of Chronic Kidney Disease. The Company is headquartered in Montreal, Canada, with a satellite office in Boston, Massachusetts. www.thrasos.com