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
See Insiders’ Hot Stocks on TipRanks >>
Read More on AKTX:
- Akari Therapeutics Announces Presentation of a Case Study from Phase 3 Part A Clinical Trial of Nomacopan in Pediatric HSCT-TMA as a Late-Breaker at The Transplantation & Cellular Therapy Tandem Meetings
- Akari Therapeutics presents case study from Phase 3 Part A trial of nomacopan
- Akari announces pre-clinical development progress toward IND for GA treatment
- Akari Therapeutics announces acceleration of Phase 3 trial of nomacopan
- Akari Therapeutics Announces Acceleration of the Phase 3 Clinical Trial of Nomacopan for Treatment of Pediatric HSCT-TMA into Pivotal Part B and Addition of a New Pipeline Program Developing Nomacopan for HSCT-TMA in Adults