Clinical-stage biopharmaceutical specialist Invex Therapeutics Ltd (ASX:IXC) reports that the first IIH patient has been randomised into the IIH EVOLVE Phase III clinical trial at VisionSA in Adelaide, South Australia.
The first patient randomised under our clinical trial marks a significant milestone for the company and IIH patients generally,” Dr Jason Loveridge, Non-Executive Chairman of Invex, said.
“We certainly thank Associate Professor Chen and her clinical team at VisionSA for their interest and participation in this very important clinical trial. Given the clinical results we have achieved to date, we believe Presendin has the potential to improve clinical outcomes and the quality of life for these IIH patients in a safe and effective manner, where current therapies remain lacking.”
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.
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.
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.