Fast Track designation has been granted to nomacopan (formerly known as Coversin; Akari Therapeutics), an investigational treatment for hematopoietic stem cell transplant associated thrombotic microangiopathy (HSCT-TMA) in pediatric patients.
There is currently no approved treatment for HSCT-TMA. Last September, the Company announced that two HSCT-TMA pediatric patients were treated with nomacopan, a C5 complement inhibitor that also independently and specifically inhibits leukotriene B4 (LTB4) activity. In both patients, signs of thrombotic microangiopathy (red blood cell fragments, thrombocytopenia, elevated lactate dehydrogenase, hypertension) resolved following treatment.
The Company stated they are working with the FDA Model Informed Drug Development (MIDD) Program to optimize pediatric dosing with nomacopan for the planned pivotal HSCT-TMA trial.
“Fast Track designation provides our HSCT-TMA clinical program a pathway for an expedited approval for nomacopan, and we plan to commence a pivotal trial in the fourth quarter of 2019,” said Clive Richardson, interim CEO of Akari.
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