Thrasos initiates Phase I clinical trial for THR-184 in acute kidney injury

MONTREAL, September 13, 2011 – Thrasos Innovation, Inc. today announced that it has initiated a Phase 1 clinical trial to study the safety and tolerability of THR-184, which the Company is developing for the treatment of Acute Kidney Injury (AKI) post-surgery. The Phase 1 study is being conducted by Algorithme Pharma of Laval, Quebec, Canada.

Thrasos Innovation, Inc. today announced that it has initiated a Phase 1 clinical trial to study the safety and tolerability of THR-184, which the Company is developing for the treatment of Acute Kidney Injury (AKI) post-surgery. THR-184 is a proprietary small peptide that selectively activates key receptors of the bone morphogenetic protein (BMP) family responsible for cell and tissue protection, repair and regeneration. 

“No drug therapies currently exist for AKI, highlighting the significant need for a treatment that could address this void and reduce the significant morbidity and mortality associated with the disease,” said Jonathan Himmelfarb, M.D., a member of Thrasos’ Scientific Advisory Board, Director of the Kidney Research Institute at Northwest Kidney Center and Joseph W. Eschbach Professor of Medicine at University of Washington. “Targeting the BMP family of proteins represents a promising approach for treating and preventing kidney disease, and Thrasos is the first company that has demonstrated the activation of the specific receptors involved in repairing and regenerating cells and tissues, while also avoiding the growth of cartilage and bone.”

“The initiation of clinical development for THR-184 follows extensive preclinical studies in which the compound demonstrated consistently positive effects for the treatment of AKI,” said Richard Andrews, President and Chief Executive Officer of Thrasos. “Thrasos’ studies have demonstrated that THR-184 may work well as both a prophylactic agent and as a therapeutic. The Company is looking forward to presenting preclinical data for this program at the American Society for Nephrology’s Kidney Week in November.”

Thrasos is also developing a second peptide: THR-123, targeted at the prevention and reduction of fibrosis in Chronic Kidney Disease resulting from diabetic nephropathy. THR-123 is currently in preclinical development and is advancing toward clinical studies.  

About the Phase 1 Trial:

The Phase 1 trial is a randomized, double-blind, placebo-controlled study that will enroll up to 72 healthy volunteers. The study is being conducted by Algorithme Pharma of Laval, Quebec, Canada. The primary objective is to investigate the safety and tolerability of single and multiple ascending doses by slow intravenous injection. The secondary objective is to explore the pharmacokinetics of THR-184.

About Acute Kidney Injury:   

AKI results from a temporary loss of kidney function due to ischemia (low blood flow to the kidney caused by surgery or trauma), inflammatory disease or nephrotoxicity (primarily due to the use of contrast dye). AKI can initiate an inflammatory cascade that may lead to multi-organ failure. Each year, millions of patients undergo cardiac and vascular surgery, as well as medical imaging procedures, and these patients are at risk for AKI. Currently, approximately one million AKI patients are diagnosed each year in the United States, all of whom experience some permanent loss of kidney function. Over 140,000 of the patients suffering from AKI progress to acute renal failure, which can lead to multi-organ failure, sepsis and a significant risk for mortality. Sixty to seventy percent of the acute renal failure patients may not survive, and as many as twelve percent of patients that do survive will leave the hospital with end-stage renal disease, requiring chronic dialysis. There are currently no drug therapies for AKI and prevention and treatment represents a $6.3 billion market opportunity annually in the U.S.

About Thrasos:  

Thrasos is a private, clinical stage, bio-therapeutics Company focused on the discovery and development of targeted therapies for the prevention and treatment of severe organ failure, with a principle focus on kidney disease. The Company’s first drug candidates were selected from an extensive inventory of active peptide compounds generated by the Company’s design technology platform, called Structure Variant Analysis (SVA). Using SVA, Thrasos has pioneered the design of compounds based on the structure of the bone morphogenetic protein (BMP) family to activate the Smad transduction pathway. The resulting peptides have been shown to protect, repair and restore cell and tissue function in the kidney and other organs.

Contacts

Thrasos Innovation, Inc.:
Richard Andrews, 514-940-2714
or
Media:
MacDougall Biomedical Communications
Sarah Cavanaugh or Jennifer Conrad, 781-235‐3060