DiaMedica’s Phase 2/3 Trial of DM199 in Acute Ischemic Stroke Still Under Clinical Hold
DiaMedica Therapeutics’ phase 2/3 clinical trial investigating its DM199 in patients with acute ischemic stroke is still under a clinical hold by the FDA while the company provides more data related to three serious adverse events.
The adverse events were low blood pressure during intravenous infusion of the drug.
In response to the clinical hold letter the FDA issued in July, the company said that the cause was likely related to switching to a different type of intravenous (IV) bag. The two types of bags showed differences in the amount of protein binding and could alter the total amount of drug being administered, the company said.
The FDA is requesting an in-use stability study of the IV administration of DM199 — including the IV tubing and mechanical infusion pump — to rule out any cause other than IV bag protein binding.