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 Drugs Agency (FDA) in IIH and holds an extensive portfolio of relevant intellectual property. Invex has trade marked its repurposed Exenatide as Presendin™.
Exenatide is a glucagon-like peptide-1 receptor agonist approved for the treatment of type II diabetes. Invex will focus 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 intends to progress expediently to clinical evaluation and undertake the registration of different formulations of Exenatide optimised to treat different neurological conditions.
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 some key measures of clinical benefit. The Company believes the data supports, subject to regulatory authority input, progression of Presendin™ into a single Phase III registration study in IIH in the US, Europe and Australia according to our orphan drug designation. Invex will now work towards initiating this study in 1H 2021.
Idiopathic Intracranial Hypertension (IIH)
IIH is a condition of unknown cause but results from raised pressure in the brain that can result in daily headaches and loss of sight, which can be permanent.