Invex Therapeutics Ltd. announced the approval to commence the IIH EVOLVE Phase III clinical trial has been received from the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) in Germany for patients with Idiopathic Intracranial Hypertension (IIH). In addition, Invex has secured Central Ethics Committee (CEC) approval for commencement of the IIH EVOLVE trial. Both BfArM and CEC approval are required to commence a clinical trial in Germany.

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.