EXCLUSIVE: Thrasos May Seek Breakthrough Status for Kidney Injury Drug, CEO Says
July 9, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Thrasos Therapeutics will be seeking a Breakthrough Status Designation from the U.S. Food and Drug Administration later this year for its kidney injury drug THR-184, the firm’s CEO told BioSpace Thursday.
“The company has fast-track status for the program already and will evaluate the potential for seeking breakthrough designation in the first half of next year,” Richard Andrews, president and CEO, told BioSpace.
Thrasos, a biotherapeutics company focused on delivering new solutions for kidney disease, has completed enrollment in its Phase II 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.
“THR-184 targets the BMP (bone morphogenic protein) pathway and acts to inhibit inflammation and apoptosis in renal epithelial cells,” said Andrews in an interview. “Protecting these cells is critical to preventing AKI.”
Andrews said the methodology for this study is adaptive, because subjects enrolled had to be scheduled for “on-Pump” major cardiac surgery (bypass, valve replacement or both) and have risk factors for AKI such as age, underlying kidney disease, diabetes and/or heart failure.
If it works, THR-184 could change the standard of care for AKI, said Andrews.
“We are targeting to prevent AKI in patients undergoing major surgery. Cardiac surgery has a high incidence of AKI but other major surgeries also carry a significant risk for patients,” he told BioSpace.
“There is no preventative or therapy available for such patients today and if successful THR-184 would be an important contribution to preventing this very serious and expensive disease process.”
If THR-184 does well, Thrasos may speed up its late-stage trials, he said. “Pending data, the company plans to move THR-184 forward to pivotal studies as soon as possible,” said Andrews.
Thrasos began its Phase II clinical study in late 2013 and has worked closely with its Canadian Clinical Research Organization (CRO) - The Montreal Health Innovations Coordinating Center (MHICC), its U.S. 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.
As New Jersey Biotech Booms, Will It Overtake Other States As Prime Location?
A week after Celgene Corporation announced it is officially the mystery buyer of Merck & Co. ’s former 1 million-square-foot R&D site in Summit, N.J., it quickly became our most popular story last week.
The company announced last Wednesday that it is buying the space, ending months of speculation about what Big Pharma company might move into the neighborhood.
The Summit, N.J. site is zoned research/office. The New Jersey site would put operations closer to some of the major biotech and pharmaceutical hubs on the East Coast.
But, by far, the most tempting part of doing business in the state remains New Jersey’s operating tax credit, which allows companies to sell their net operating losses to the New Jersey Treasury. One of the state’s most recognizable biotechs, Celgene, used the program until it became profitable, which was key to it staying in the state, said local officials.
That has BioSpace is wondering if New Jersey is becoming the new face of biotech. What do you think? Can the Garden State compete with other longtime stalwarts like California or Boston?