Development Strategy

Our Approach

Invex is focused on the development of therapeutics to treat diseases caused by raised intracranial pressure. Elevated intracranial pressure is caused by alterations in the volume of either cerebral blood, cerebrospinal fluid (CSF), or brain tissue. CSF volume is tightly regulated and depends on the balance between CSF secretion, which is modulated predominantly by the choroid plexus, and drainage through the arachnoid granulations and lymphatics. We aim to utilise our understanding of the mechanisms that regulate pressure in the brain to repurpose an already approved drug – Exenatide – to reduce intracranial pressure in diseases such as Idiopathic Intracranial Hypertension (IIH). Invex has been granted Orphan Drug Designation for Exenatide by both European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in IIH and holds an extensive portfolio of relevant intellectual property. Invex has trademarked its repurposed Exenatide as Presendin™.

Exenatide

Exenatide is a glucagon-like peptide-1 receptor agonist approved for the treatment of type II diabetes. Invex has focussed on reformulating Exenatide to deliver it in a way that enables exploitation of its previously unknown ability to reduce cerebral spinal fluid secretion in the choroid plexus of the brain. By exploiting the safety record of Exenatide and successfully solving the required reformulation challenges, Invex has plans to conduct clinical trials of Exenatide to treat pressure-related neurological conditions including traumatic brain injury. In addition, Invex has established a collaboration with the Tessara Therapeutics, gaining access to their ADBrain™ platform, a 3D human brain model that replicates the neurodegeneration seen in Alzheimer’s Disease (AD). Initial results are very encouraging.

Idiopathic Intracranial Hypertension (IIH)

IIH is a condition of unknown cause (idiopathic) but results from raised intracranial pressure in the brain that can result in daily headaches and loss of sight, which can be permanent. The usual age of onset is 20-30 years, and it is most common in women (>90% of cases) who are obese. IIH is a rapidly growing orphan indication, with its incidence has increased by more than 350% in the last 10 years. Historically, the rate of a diagnosis of IIH was approximately 60%; however, with the introduction of diagnostic criteria (2015) and consensus treatment guidelines (2018), the awareness of IIH is growing and diagnostic rates are anticipated to improve. Apart from drastic weight loss and invasive neurosurgical (brain) or ophthalmological (eye) surgical interventions, there are currently no FDA or European Medicines Agency (EMA) approved drugs to treat IIH. Invex’s strategic objective is to gain approval of Presendin™ for IIH across all major jurisdictions. This represents an annual market opportunity of A$1.6 billion in the US and Europe/UK.

Exenatide Meets Key Endpoints in Clinical Trial in IIH

A Phase II, double-blind, placebo-controlled clinical trial was completed in patients with IIH in May 2020 demonstrating a statistically significant reduction in key endpoints in the Exenatide arm, including all three primary endpoints related to intracranial pressure as well as in key measures of clinical benefit, including headache and vision. The data supports the progression of Presendin™ into a single Phase III registration trial in IIH in Europe, the UK and Australia according to our orphan drug designation. In addition, the Company is including US centres in the Phase III trial under an Investigational New Drug Application (IND) to build clinical/patient awareness and facilitate future discussions with the FDA. Invex’s Phase III plans are well advanced and expects to commence the trial, known as IIH EVOLVE in 2022.