Akari Therapeutics announced updates in the development programs investigating nomacopan in pediatric and adult hematopoietic stem cell transplant-related thrombotic microangiopathy, HSCT-TMA. Akari is on track to begin patient enrollment in the registrational Phase 3 study of nomacopan in pediatric HSCT-TMA that is expected to produce safety and efficacy data supportive of a potential regulatory filing and approval. Akari also is planning to move forward into a Phase 3 double-blind placebo-controlled clinical trial of nomacopan in adult HSCT-TMA and to open enrollment in 2024. “Our goal is to bring an approved treatment to both children and adults in desperate need, and we are deeply committed to making a positive impact on the standard of care now and down the road for patients facing this devastating condition,” said Rachelle Jacques, Akari President and CEO. Akari is advancing into Phase 3 open-label single-arm study of nomacopan in pediatric HSCT-TMA and is planning to move into a Phase 3 double-blind placebo-controlled study of nomacopan in adult HSCT-TMA in 2023 and 2024, respectively.
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