Akari Therapeutics, Plc (Nasdaq: AKTX) is thrilled to announce that regulatory authorities in Poland and the U.K. have officially approved amendments to the company’s Investigational Medicinal Product Dossier (IMPD) and Clinical Trial Authorisation (CTA) for clinical use of the third-generation drug substance manufacturing process.
This process increases the final yield of nomacopan, an investigational bispecific inhibitor of both complement C5 and leukotriene B4 (LTB4), by at least 5-fold. Nomacopan is currently being tested in Phase 3 clinical trials for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA).
Akari Therapeutics is taking another significant stride in its clinical trial of nomacopan in pediatric HSCT-TMA, with recent clearance from regulators in the U.K. and Poland of its enhanced production process. According to President and Chief Executive Officer Rachelle Jacques, this is an important step forward for the company.
Nomacopan has entered Phase 3 clinical trials to assess its efficacy in pediatric HSCT-TMA patients, with sites located in Poland, the U.K. and the U.S. – giving hope to young people and their families that this novel therapy could help reduce the burden of this often life-threatening condition.
About Akari Therapeutics
Akari Therapeutics, plc (Nasdaq: AKTX) is an innovative biotechnology company working to bring forward treatment options for autoimmune and inflammatory diseases. Their lead candidate, investigational nomacopan, is a unique bispecific recombinant inhibitor of both complement C5 activation and leukotriene B4 (LTB4) activity.
Akari’s pipeline includes a Phase 3 clinical trial program for nomacopan for severe pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA).
As a result of their groundbreaking research, the FDA has granted Orphan Drug, Fast Track and Rare Pediatric Disease designations for nomacopan for the treatment of pediatric HSCT-TMA. Akari is also working on a clinical program for adult HSCT-TMA and pre-clinical research of long-acting PAS-nomacopan in geographic atrophy (GA).