Akari Therapeutics (NASDAQ:AKTX) had a positive pre-IND meeting with the FDA about its proposed pivotal clinical trial program for Coversin for the treatment of pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA).
HSCT-TMA is a bone marrow transplant complication where damage to cells lining the circulatory system results in small vessel blood clots. HSCT-TMA is an orphan condition with a fatality rate of more than 80% in children.
Coversin is a recombinant small protein that inhibits the complement and leukotriene pathways, which play a key role in the immune response and inflammation.
Akari plans to initiate the trial in European and U.S. pediatric HSCT-TMA patients in the fourth quarter of 2019.
