Invex Therapeutics to begin recruiting IIH patients in NZ for clinical trial following regulatory approvals
Invex Therapeutics has gained approvals from the NZ Medicines and Medical Devices Safety Authority and the country’s Health and Disability Ethics Committee to recruit patients into its IIH Evolve phase III trial.
Invex Therapeutics (ASX: IXC) has secured approval to expand its Evolve phase III clinical trial into New Zealand, where it will evaluate its drug Presendin in patients with idiopathic intracranial hypertension (IIH).
The New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) granted approval for the trial along with Invex getting the green light from the country’s Health and Disability Ethics Committee.
Gaining regulatory approvals paves the way for Invex to begin recruiting patients into the New Zealand arm of the trial.
Invex executive director and chief scientific officer Prof Alex Sinclair said the company had received interest from specialist clinicians in New Zealand regarding participating in the IIH Evolve phase III trial.
She said clinicians are seeking new effective therapies to treat IIH due to rising incidences in parallel with increasing obesity rates in the general population.
IIH Evolve
The ability to begin recruiting IIH patients in NZ follows Invex enrolling its first randomised patient at VisionSA in South Australia earlier this week.
Other trial sites have begun actively for recruiting in Australia and the UK, with a total of 40 sites to be opened globally.
All-up, the IIH Evolve phase III trial will take on about 240 patients with newly diagnosed IIH to determine safety and efficacy of Presendin compared to a placebo administered once a week over 24 weeks.
The primary end-points for the trial are to see a change in intracranial pressure from baseline, with secondary end-points relating to vision and headache outcomes.
Idiopathic intracranial hypertension
IIH is caused by “severely raised” intracranial pressure, which can trigger disabling headaches and compress the optic nerve.
The conditional is most prevalent in obese women and onset is usually 20-30 years.
It is a rapidly growing disease, with incidences increasing 350% over the last decade.
Invex’s IIH Evolve phase III trial is designed to meet market approval requirements for the drug to be approved to treat IIH in the European Union, UK, and Australia.