Argenica Therapeutics (ASX:AGN) has announced the completion of crucial safety studies that are required to be included in its IND application.
The IND application is a request made by a clinical sponsor to obtain authorisation from the US FDA to administer an experimental drug to humans in clinical trials. Obtaining authorisation and opening an IND will enable Argenica to do later stage clinical trials in patients in the US with acute ischaemic stroke (AIS).
Argenica managing director Dr Liz Dallimore said the results generated from the company's studies support the IND application and provide further confirmation that ARG-007 has a unique mechanism of action and pharmacological profile which lends itself to being an ideal therapy in acute ischaemic stroke.
"We are working with our FDA regulatory consultants to compile the documentation required for our IND application, and with the completion of these studies, the Company is now well positioned to submit the IND application to the FDA by the end of this calendar year.”
Argenica said it is currently drafting its IND submission, which is anticipated to be submitted to the FDA by the end of calendar year 2024.
