UK and Polish regulatory authorities approve Akari Therapeutics’ higher-yielding manufacturing process

pharmafile | March 30, 2023 | News story | Manufacturing and Production  

Akari Therapeutics has announced that the UK’s MHRA and the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) have given clearance to amendments to Akari’s manufacturing process, which will increase the yield of nomacopan at least five-fold.


The amendments were made to Akari’s Investigational Medicinal Product Dossier (IMPD) and Clinical Trial Authorisation (CTA) by URPL and MHRA respectively.


Nomacopan is an investigational bispecific recombinant inhibitor of both complement C5 activation and leukotriene B4 (LTB4) activity. It has been granted Orphan Drug, Fast Track and Rare Paediatric Disease designations from the FDA. Currently it is in phase 3 trials in Poland, UK and US, which are studying nomacopan’s efficacy in paediatric haematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA).


Akari state that its pipeline also includes developing nomacopan for adult HSCT-TMA patients, and pre-clinical research of long-acting PAS-nomacopan in geographic atrophy (GA).


Rachelle Jacques, president and CEO of Akari Therapeutics, commented: “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 paediatric HSCT-TMA.”


James Spargo

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