Toronto-based Spectral developed a stand-alone pump, the Toraymyxin device, designed for use with an assay to identify endotoxin levels. The system aims to use a 2-column hemoperfusion to remove septic toxins from the bloodstream; Spectral Medical licenses the technology for the North American market from Japan’s Toray Industries (TYO:3402).
The company, which has said it plans to file its final pre-market approval module with the FDA for Toraymyxin by the end of the year, said its 446-patient Euphrates trial missed the primary endpoint of 28-day mortality compared with the standard of care. CEO Dr. Paul Walker told Reuters that the mortality reduction number took a hit from a smaller-than-expected endotoxin decrease.
“We proved beyond doubt that endotoxin is bad and taking it out is good,” and Spectral will discuss next steps with the FDA, CEO Paul Walker told Reuters, noting that if the company can show that “more columns take out more endotoxin, then I think we can get approved.”
Toray has been selling Toraymyxin in Japan for more than 20 years and in Canada since 2002, but trials have failed prove its efficacy. Walker said Spectral will likely need to run an additional, observational study of a 4-column system to prove the mortality benefit. That could push U.S. approval out to early 2018, he told the news service.
“The trial clearly showed that the Toraymyxin medical device is safe and, even though statistically significant reduction in 28 day mortality was not achieved with this sample size, the 5% mortality reduction in the per protocol population combined with the other positive benefits observed in treated septic shock patients is encouraging,” Dr. Bert Spilker, chairman of the Data Safety Monitoring Board, said in prepared remarks.
“The data demonstrates a very clear correlation between the amount of endotoxin removal and reduction in mortality. The basic premise of a dose response relationship between the amount of endotoxin removed and related benefits is seen,” Walker added. “The overall data from our pivotal Phase III trial clearly demonstrates a clinically relevant impact on patient lives. We plan to take this robust information to the FDA to discuss our regulatory pathway towards potential approval.”
In late June, Spectral won compassionate use expanded access from the FDA for the Toraymyxin blood treatment device. A financing round brought in $10.5 million in February.
EDT shares were down -81.1% to C30.5¢ today in mid-morning trading.