Imagine a headache so intense that the literal ear-throbbing pain results in blindness or other vision impairments. Even though sometimes it may not be so extreme, Idiopathic Intracranial Hypertension (IIH) can take such a form, making it integral to develop a cure for the same. Invex (ASX: IXC) believes that it has got one with its trademark drug Presendin.

The Company has randomised its first IIH patient into the IIH EVOLVE Phase III clinical trial of its drug at VisionSA in Adelaide, South Australia. Invex is a clinical-stage biopharmaceutical company known for its patented drug Presendin. The medication features exenatide, which alleviates intracranial pressure (pressure on the skull)—a symptom of IIH. Since starting phase II in 2019, the Company is finally at the next stage.

Non-Executive Chairman of Invex, Dr Jason Loveridge, commented, “The first patient randomised under our clinical trial marks a significant milestone for the Company and IIH patients generally. 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.”

In Australia, the incidence of IIH is reportedly more significant than cervical cancer in women aged between 20 to 40 years old dealing with obesity. Overall, IIH’s prevalence has increased by over 300 per cent in the past decade. The urgency to find treatment is evident.

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. Presendin will be administered once weekly over 24 weeks. The trial’s primary goal is to note the change in intracranial pressure from baseline, with critical secondary endpoints related to vision and headache outcome measures. Invex intends to open up to 40 clinical sites globally. 

And it is going full steam ahead with this goal. In October this year, the Company activated two sites, one in Australia and one in the UK, for the EVOLVE phase III trials. In Australia, it opened its first site at VisionSA in Adelaide, South Australia, where the first patient has been randomised, and in the UK, at the University Hospital, Birmingham.

The IIH EVOLVE trials are designed to meet the requirements for market approval of Presendin™ for the treatment of Idiopathic Intracranial Hypertension (IIH) in the European Union (EU), United Kingdom (UK) and Australia.

Moreover, during Q1 FY23, the Company received United States (US) Food and Drug Administration (FDA) Investigational New Drug Application (IND) approval for Presendin™ and the commencement of the IIH EVOLVE Phase III clinical trial in America for patients with IIH. With support from US clinicians, Invex aims to open ten clinical sites in the US.

The Company anticipates receiving further clearances in New Zealand, Israel and Europe from Q4 CY2022 onwards. 

In this quarter, Invex spent $2 million as it started onboarding patients and expanding its base. With $27 million in the bank and R&D rebates from governments, the Company is poised well to see through its mission.

Currently, IIH patients have to resort to surgery or drugs with severe side effects. With Presendin, hopefully, patients will be able to move on relatively easily and live a good quality of life.