Argenica Therapeutics (ASX:AGN) states that it has received correspondence from the US FDA, indicating that a clinical hold has been placed on the company's Investigational New Drug (IND) Application.
Argenica said the FDA has indicated that the non-clinical data package provided in the IND is not adequate to support initiation of a proposed Acute Ischaemic Stroke (AIS) trial in the US at this time. No further details on the FDA’s additional requirements have been provided at this time. However, the company said it expects further detailed correspondence from the FDA within 30 days.
Argenica stated that the correspondence from the FDA does not impact the current Phase 2 clinical trial being conducted in Australia, which is on track for data readout in the third quarter of calendar year 2025.
Argenica had anticipated that there may be some challenges in receiving an open IND within the 30-day time period due to current resourcing challenges at the FDA, hence the decision to submit the AIS IND application much earlier than required to start anticipated future clinical trials in the US.
Argenica managing director Dr Liz Dallimore said, “Whilst we are obviously disappointed with the hold placed on our AIS IND application, we are confident we can provide the additional data required by the FDA in a timely manner and move towards opening our AIS IND in the near future. We will keep the market informed once we know the nature of the FDA’s additional requirements.”