Of the 332 patients enrolled, 148 patients have already completed the required six months of treatment. The company expects to have the last patient complete the six months of active treatment before the end of the year. Furthermore, 43 patients have so far completed an additional six months of treatment in the optional extension phase of this trial.
As previously announced, Health Canada granted a no objection letter allowing patients who have already completed 12 months treatment with the drug, ISA247, to continue therapy through to commercialization of the drug.
“Upon receipt of these results, the company expects to submit applications to conduct the pivotal phase III trials that are required for market approval,” said Randall Yatscoff, Isotechnika’s president and CEO.
“The only two existing drugs in the class of calcineurin inhibitors share a market size of approximately $2.2 billion annually. We are therefore encouraged not only by the clinical prospects but also by the market potential of ISA247 as the only late-stage calcineurin inhibitor currently under development.”