The New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) has granted approval to Invex Therapeutics to begin the Phase III IIH EVOLVE clinical trial of Presendin (sustained release (SR) Exenatide) to treat idiopathic intracranial hypertension (IIH) patients.
The company also received the Health and Disability Ethics Committee’s approval, which is needed to carry out trials of new therapies in the country.
To be carried out at up to 40 study centres across the globe, the trial will enrol 240 subjects with recently diagnosed IIH.
The randomised, placebo-controlled, double-blind, multi-centre trial will evaluate the efficacy and safety of Presendin compared to a placebo, given once a week for more than 24 weeks.
The variation in intracranial pressure (ICP), as evaluated by lumbar puncture, from baseline to 24 weeks is the trial’s primary endpoint.
Secondary endpoints of the trial comprise the variation in perimetric mean deviation (PMD), papilloedema, and monthly headache days over 24 weeks.
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A subcutaneous, sustained-release (SR) Exenatide microsphere formulation, Presendin was initially developed by Peptron.
Invex signed an exclusive partnership, manufacturing, and supply agreement with Peptron in September last year for Presendin in IIH for all key markets, excluding South Korea.
A small peptide and a synthetic form of the GLP-1 agonist exendin-4, Exenatide is approved to treat type 2 diabetes.
Invex executive director and chief scientific officer professor Alex Sinclair said: “We are pleased to be recruiting patients for the IIH EVOLVE clinical trial in New Zealand, where specialist clinicians have conveyed to the Invex team an interest in participating in our trial as they seek new effective therapies to treat IIH, where the incidence is rising, consistent with increasing rates of obesity in the general population.”
In July this year, the company received approval in Australia to commence the IIH EVOLVE trial of Presendin for IIH in the country.