Invex Therapeutics Ltd. announced the first IIH patient has been randomised into the IIH EVOLVE Phase III clinical trial at VisionSA in Adelaide, South Australia. 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.

Invex intends to open up to 40 clinical sites globally. Information on the trial is available at clinicaltrials.gov under Identifier NCT05347147.