Perth-based neurological drug developer Argenica Therapeutics has been knocked back by the US Food and Drug Administration, dashing hopes its US clinical trials would soon start.
Perth-based neurological drug developer Argenica Therapeutics has been knocked back by the US Food and Drug Administration, dashing hopes its US clinical trials would soon start.
Nedlands-based Argenica told the market today it had received correspondence from the FDA that a clinical hold had been placed on the application after the FDA found non-clinical data provided in the company’s Investigational New Drug application did not support initiation of a trial.
The Liz Dallimore-helmed company said it expected to receive further correspondence within 30 days detailing additional requirements to gain support for a trail of its flagship ARG-007 from the FDA.
It comes as the company continues its phase two clinical trials in Australia, with data from that trial expected to be delivered in the third quarter of this calendar year.
In the statement, the company said it had submitted the IND application much earlier than required, as it understood the FDA was experiencing resourcing challenges.
Despite this, the company said it had addressed all requests covering non-clinical information made by the FDA in the application.
Argenica managing director Dr Liz Dallimore said the company still intended to pursue US trials.
“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,” she said.
“We will keep the market informed once we know the nature of the FDA’s additional requirements.”
The company’s ongoing trails of ARG-007 in Australia aim to treat patients with the most common type of stroke, which is caused by a blood vessel clot to part of the brain.
Discovered in Perth and researched for more than a decade at the Perron Institute, ARG-007 is designed to protect brain tissue from dying until blood flow can be restored to reduce further brain injury and long-term disability.
Perth’s Sir Charles Gairdner and Fiona Stanley hospitals are among the 10 hospitals set to be involved in the double-blind trial, which will enrol 92 patients.
Argenica has previously said it was hoped ARG-007 would eventually be administered by first responders, if the drug was approved.
Argenica shares fell nine per cent following the announcement, to 70 cents per share.
