Argenica Therapeutics (ASX:AGN) has received the full clinical hold letter from the US FDA.
The letter details the additional information the FDA requires to lift the clinical hold on the company’s investigational new drug application (IND) for ARG-007, a therapeutic aimed at reducing brain tissue death after stroke.
To resolve the clinical hold, the FDA has asked Argenica to provide evidence that the proposed clinical trial dose can be achieved safely in humans. Argenica said it will include safety data from its ongoing Phase 2 trial as part of this response.
The regulator has also requested an in vitro clot-lysis study using Tenecteplase performed with human blood clots at a contract research organisation, an hERG in vitro assay to evaluate any potential effects of ARG-007 on cardiac potassium channels and electrical activity, a follow-up in vitro mammalian cell gene mutation test, and a more detailed presentation of the Phase 1 data in the investigational brochure.
Argenica’s Managing Director, Dr Liz Dallimore, said, “We are pleased to have received clarification from the FDA on the additional information required to progress the IND application. From both timing and cost perspectives, the requested additional in vitro assays are standard, straightforward and efficient to perform. Importantly, safety data from our ongoing Phase 2 trial will be available in September to support our submission. Argenica will work with the FDA to ensure our proposed approach addresses their requirements and leads to lifting the clinical hold.”
Argenica said it will now arrange the required CRO studies and prepare the updated materials for submission to the FDA.