Invex Therapeutics Ltd. announced the opening of the Company's first United States (US) clinical site at the Eye Wellness Center in Bellaire, Texas with Dr. Rosa Tang. On 19 August 2022, the Company received US Food and Drug Administration (FDA) Investigational New Drug Application (IND) approval for PresendinTM and for the commencement of the IIH EVOLVE Phase III clinical trial in the US for patients with IIH. 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 Presendin 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.