Akari Therapeutics announced regulatory authorities in Poland and the U.K. have approved amendments to the company’s Investigational Medicinal Product Dossiernd Clinical Trial Authorisation, respectively, for clinical use of the third-generation drug substance manufacturing process that increases the final yield of nomacopan by at least 5-fold. "The clearance by regulators in the U.K. and Poland of Akari’s newer, enhanced manufacturing process for nomacopan is another important step forward in our progress toward the pivotal Part B in our clinical trials in pediatric HSCT-TMA," said Rachelle Jacques, President and Chief Executive Officer of Akari Therapeutics. The Phase 3 study of nomacopan in pediatric HSCT-TMA includes clinical trial sites in Poland, the U.K. and U.S.
Published first on TheFly
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