Invex Therapeutics aims to repurpose a diabetic drug for brain disorders

Invex Therapeutics ASX IXC repurpose diabetic drug brain disorders Exenatide IPO
Invex Therapeutics aims to reformulate an approved diabetic drug to treat neurological conditions including idiopathic intracranial hypertension, traumatic brain injury and acute stroke.

Biopharmaceutical company Invex Therapeutics is planning to make its ASX debut this week under the ticker code “IXC” with ambitions to repurpose an approved diabetes drug for some neurological conditions.

Through its initial public offering (IPO), the Perth-based company is aiming to raise a minimum of $10 million by offering 25 million shares at $0.40 each.

Invex non-executive director David McAuliffe told Small Caps the listing date was an indicative timeframe with some documents still needing to be finalised, but if all goes to plan the company should be set to float on Thursday or Friday.

Reducing pressure on the brain

Invex is focused on developing effective treatments for neurological conditions derived from or involving raised intracranial pressure, which is pressure inside the skull including the brain tissue and cerebrospinal fluid.

This pressure can be caused by a number of factors including conditions such as idiopathic intracranial hypertension (IIH), traumatic brain injury, and acute stroke.

The company was founded based on research undertaken by its chief scientific officer Dr Alexandra Sinclair at the University of Birmingham in the United Kingdom, which demonstrated that the drug Exenatide could reduce this intracranial pressure.

Exenatide is already approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of Type II diabetes.

According to Invex, Dr Sinclair has demonstrated in animal models that the drug, when injected under the skin, can reduce intracranial pressure by reducing cerebral spinal fluid secretion in the choroid plexus of the brain.

“We are planning to reformulate Exenatide and target a number of different diseases that involve increased brain pressure,” Mr McAuliffe said.

“Over 10 years of research has gone into this project prior to the IPO and numerous papers have been published in prestigious medical journals around all the work to date,” he added.

Invex non-executive chairman Dr Jason Loveridge said the company’s first target indication will be IIH, which is a condition of unknown cause but is typically associated with obesity, young people and, particularly, females.

IIH is a debilitating condition that can result in daily headaches and even the loss of sight, as the pressure can compress the nerves supplying the eye.

“Invex is utilising its knowledge of both the disease and the mechanism of action of the drug Exenatide to repurpose the drug and enable delivery kinetics that are matched to the needs of the disease,” Dr Loveridge said in the chairman’s letter of the company’s prospectus.

Proof of concept study

Invex has partially sponsored a phase two proof of concept study exploring the physiological effects of Exenatide in reducing intracranial pressure in IIH patients.

The study involves 16 female patients with IIH being treated with either Exenatide or a placebo for 12 weeks.

In addition to measuring intracranial pressure, several other measurements will be taken to evaluate secondary endpoints including headaches and visual assessments.

According to the company, the study is currently underway with 10 out of 16 patients completed and data is expected to be published in the first half of 2020.

Patent applications

The University of Birmingham has filed patent applications to use Exenatide for a range of indications including IIH. It also has orphan drug designations for the drug in IIH in the US and Europe.

Invex said these patent applications and orphan designations would be assigned to the company at the completion of its IPO.

Development plans

Invex’s IPO funds will be used to continue the repurposing and commercialisation of Exenatide by funding a series of development activities.

These include acquiring the relevant intellectual property from the University of Birmingham and paying patent costs, as well as completing the reformulation of Exenatide.

In addition to completing its phase two proof of concept clinical study on IIH, the company will initiate proof of concept studies for other indications such as traumatic brain injury and stroke.

Invex is also aiming to initiate a phase two clinical study to support approval for the use of Exenatide in treating IIH in the US and Europe.

Dr Loveridge said Invex was looking to take advantage of the “significant commercial opportunity” that IIH presents as the market is underpinned by “a pool of poorly treated existing patients coupled with accelerating incidence in-line with growing obesity in Western countries”.

He added that the company has the potential to speed up development and reduce costs as well as risk since its research is based on the reformulation of an already approved drug, which has a record of safe use over extended periods in diabetic patients.

Mr McAuliffe said he hopes Invex’s listing will attract Australian technology investors as the company “moves the technology towards commercialisation”.