Invex Therapeutics (ASX:ISC) has received regulatory approval in Germany to commence the IIH EVOLVE Phase III clinical trial for patients with Idiopathic Intracranial Hypertension (IIH).
Invex says it's the first national regulatory clearance in Europe, and is a key step towards obtaining market approval of its drug, Presendin™, in the European Union, United Kingdom, and Australia.
IIH EVOLVE is a randomised, placebo-controlled, double-blind trial that will randomise 240 patients to receive either Presendin™ or placebo, administered once weekly over 24 weeks.
The primary endpoint is the change in intracranial pressure from baseline, with key secondary endpoints related to vision and headache outcome measures.