A regulatory agency has approved Invex Therapeutics’ (ASX:IXC)
authorisation to commence the IIH EVOLVE phase 3 clinical trial in the UK, for patients with idiopathic intracranial hypertension.
The biopharmaceutical company said that it intends to open a number of clinical sites across the UK, and will now rapidly progress institutional contracts to commence patient recruitment.
The primary endpoint of the trial is related to the change in intracranial pressure from baseline, with key secondary endpoints related to vision and headache outcome measures.
“Through seeking regulatory approvals sequentially, Invex has achieved a more efficient and cost-effective execution of the global IIH EVOLVE Phase III clinical trial and we now expect the first IIH patient to be randomised and dosed after 30 June 2022,” said non-executive chairman Jason Loveridge.
Invex noted that it remains confident that all necessary approvals in Australia will be completed during the September quarter.
Shares are trading 3.4 per cent higher at 46 cents.