The approvals include those from Human Research Ethics Committee (HREC) and the clearance for Clinical Trial Notification (CTN) scheme by the Australian Therapeutic Goods Administration (TGA).
Developed by Peptron , Presendin is a sustained release (SR) Exenatide microsphere formulation intended to be administered subcutaneously once a week.
Invex signed an exclusive partnership, manufacturing and supply agreement with Peptron for Presendin in IIH for key markets, excluding South Korea, in September last year.
The current approval from HREC covers various private hospital sites in the country that will carry out this trial while Invex also plans to submit another application to the committee for a single public hospital in Australia soon.
The company has initiated Australian IIH EVOLVE trial sites and plans to begin subject recruitment on obtaining separate institutional authorisations.
This placebo-controlled, randomised, double-blind trial will enrol 240 newly diagnosed IIH patients to assess the safety and efficacy of Presendin compared to placebo over 24 weeks.
The variation in intracranial pressure (ICP), as assessed by lumbar puncture, from baseline is the trial’s primary endpoint.
Secondary endpoints comprise the variation in perimetric mean deviation (PMD), papilloedema and monthly headache days over 24 weeks.
Up to 40 clinical sites will be launched across the globe to analyse Presendin.
Invex Therapeutics executive director and chief scientific officer professor Alex Sinclair said: “We are delighted to receive the approvals from the HREC and TGA to commence this ground-breaking study in IIH.
“We believe the lack of approved therapies for IIH and the associated unmet medical need in this study population augers well for strong clinician support, efficient patient enrolment and execution of this high quality randomised controlled clinical trial.”