Invex Therapeutics recruits first idiopathic intracranial hypertension patient to Presendin trial
Invex Therapeutics aims to reformulate an approved diabetic drug to treat neurological conditions including idiopathic intracranial hypertension, traumatic brain injury and acute stroke.
Clinical-stage biopharmaceutical company Invex Therapeutics (ASX: IXC) has randomised the first idiopathic intracranial hypertension (IIH) patient into its IIH Evolve Phase III clinical trial using lead drug Presendin.
The patient was recruited at VisionSA in South Australia, and other clinical trial sites have since become active and open for recruitment in Australia and the UK.
Non-executive chairman Dr Jason Loveridge said it represents a significant milestone for the company and IIH patients in general.
“Given the results we have achieved to date, we believe Presendin has the potential to improve clinical outcomes and the quality of life for IIH patients in a safe and effective manner, where current therapies remain lacking,” he said.
About the clinical trial
Evolve is a placebo-controlled, double-blind trial which will randomise 240 patients with newly-diagnosed IIH to determine the efficacy and safety of Presendin versus placebo, administered once weekly over a six month period.
The primary endpoint of the trial is a 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 worldwide.
Dr Loveridge said the trial is designed to meet the requirements for market approval of Presendin for the treatment of IIH in the European Union, United Kingdom and Australia.
Microsphere formulation
Presendin is a once-per-week, subcutaneous, sustained-release Exenatide microsphere formulation originally developed by South Korean biopharma company Peptron Inc, which develops sustained-release peptide-based medicines with high technological barriers to treat life-threatening and chronic diseases.
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.
Disabling headaches
IIH features severely raised intracranial pressure which causes disabling daily headaches and can compress the optic nerve.
The usual age of onset is around 30 years and the condition is most common in women who are obese.
IIH is a rapidly-growing orphan indication, with an incidence that has increased by more than 350% in the last 10 years.