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Catalent to Support DiaMedica Trial Using GPEx Technology

DiaMedica receives FDA approval to begin Phase II trials of its lead candidate, DM199, for chronic kidney disease

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By: Kristin Brooks

Managing Editor, Contract Pharma

DiaMedica Therapeutics has received U.S. FDA approval to begin Phase II trials of its lead candidate, DM199, for chronic kidney disease (CKD). Catalent has produced a cGMP batch of the drug for DiaMedica at Catalent’s Madison, WI facility to support the trial using its GPEx cell line development technology. DiaMedica intends to initiate enrollment in the study in the next few weeks. Catalent’s GPEx technology creates stable, high-yielding mammalian cell lines with high speed and efficiency. ...

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