Invex Therapeutics Ltd. announced approval to commence the IIH EVOLVE Phase III clinical trial has been received from the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) for patients with Idiopathic Intracranial Hypertension (IIH). In addition, the Company has received formal approval from the New Zealand Health and Disability Ethics Committee, which is an additional requirement to undertake clinical trials of new medicines in the country. IIH EVOLVE is a randomised, placebo-controlled, double-blind trial that will randomise 240 patients with newly diagnosed IIH to determine the efficacy and safety of PresendinTM versus placebo, administered once weekly over 24 weeks.

The primary endpoint of the trial is the change in intracranial pressure from baseline, with key secondary endpoints related to vision and headache outcome measures.