Clinical-stage biopharmaceutical company Invex Therapeutics Ltd (ASX:IXC) has received approval to commence the IIH EVOLVE Phase III clinical trial has been received from the Central Ethics Committee (CEC) and State of Israel Ministry of Health for patients with Idiopathic Intracranial Hypertension (IIH) in Israel.
Invex intends to activate up to nine clinical sites in Israel as part of the IIH EVOLVE Phase III clinical trial. All proposed sites have been previously qualified, with Invex to immediately commence contractual discussions with these individual sites.
As a result of this approval, we look forward to moving rapidly to activate a number of clinical sites in Israel where clinician interest for our trial has been particularly strong and the incidence of IIH for females of child bearing age is growing,” Professor Alex Sinclair, Executive Director and Chief Scientific Officer of Invex, said.
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.
About Idiopathic Intracranial Hypertension (IIH)
IIH features severely raised intracranial pressure which causes disabling daily headaches and can compress the optic nerve. The usual age of onset is 20-30 years, and it is most common in women who are obese. IIH is a rapidly growing orphan indication: its incidence has increased by more than 350% in the last 10 years.
About Presendin
Presendin is a once per week, sub-cutaneous, sustained-release (SR) Exenatide microsphere formulation originally developed by Peptron, Inc. (KOSDAQ: 087010). In September 2021 Invex entered into an exclusive collaboration, manufacturing and supply agreement with Peptron for Presendin in IIH for all major markets, with the exception of South Korea.
Exenatide is a small peptide and a synthetic version of the GLP-1 agonist exendin-4, which is currently approved for the treatment of type 2 diabetes. In 2017, Invex received orphan drug designation for Exenatide in IIH from the US Food and Drug Administration and European Medicines Agency.
