MEDSAFE and Ethics Approval for IIH EVOLVE Trial in NZ

Invex Therapeutics Limited │ ABN 29 632 145 334│ Level 2, 38 Rowland St, Subiaco, Perth WA 6008 │ ASX / Media Release 25 November 2022 MEDSAFE and Ethics Approval for IIH EVOLVE Trial in New Zealand Invex Therapeutics Ltd (Invex, ASX:IXC, or the Company) a clinical-stage biopharmaceutical company focused on the development and commercialisation of Presendin™ (sustained release Exenatide) for neurological conditions relating to raised intracranial pressure , today announces approval to commence the IIH EVOLVE Phase III clinical trial has been received from the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) for patients with Idiopathic Intracranial Hypertension (IIH). In addition, the Company has received formal approval from the New Zealand Health and Disability Ethics Committee, which is an additional requirement to undertake clinical trials of new medicines in the country. Professor Alex Sinclair, Executive Director and Chief Scientific Officer of Invex said “We are pleased to be recruiting patients for the IIH EVOLVE clinical trial in New Zealand, where specialist clinicians have conveyed to the Invex team an interest in participating in our trial as they seek new effective therapies to treat IIH, where the incidence is rising, consistent with incre asing rates of obesity in the general population.” 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, administered once week ly over 24 weeks . The primary endpoint of the trial is the change in intracranial pressure from baseline, with key secondary endpoints related to vision and headache outcome measures. Invex intends to open up to 40 clinical sites globally . Information on the trial is available at clinicaltrials.gov under Identifier NCT05347147. - ENDS - This release dated 25 November 2022 has been authorised for lodgement to ASX by the Board of Directors of Invex Therapeutics. For more information, please contact: Company/Investors Dr Thomas Duthy Executive Director [email protected] +61 402 493 727 Media Margie Livingston Ignite Communications [email protected] +61 438 661 131 Invex Therapeutics Limited │ ABN 29 632 145 334│ Level 2, 38 Rowland St, Subiaco, Perth WA 6008 │ 2 To subscribe to Invex email alerts, please visit www.invextherapeutics.com and follow us on Twitter @InvexThera_ASX About Invex Therapeutics Ltd Invex is a biopharmaceutical company focused on the repurposing of an already approved drug, Exenatide, for efficacious treatment of neurological conditions derived from or involving raised intracranial pressure, such as Idiopathic Intracranial Hypertensio n (IIH), acute stroke and traumatic brain injury. Invex has trademarked its repurposed Exenatide as Presendin ™. www.invextherapeutics.com. About Idiopathic Intracranial Hypertension (IIH) IIH features severely raised intracranial pressure which causes disabling daily headaches and can compress the optic nerve. The usual age of onset is 20 -30 years, and it is most common in women who are obese. IIH is a rapi dly growing orphan indication: its incidence has increased by more than 350% in the last 10 years. About Presendin™ Presendin™ is a once per week, sub -cutaneous, sustained -release (SR) Exenatide microsphere formulation originally developed by Peptro n, Inc. (KOSDAQ: 087010). In September 2021 Invex entered into an exclusive collaboration, manufacturing and supply agreement with Peptron for Presendin™ in IIH for all major markets, with the exception of South Korea. Exenatide is a small peptide and a synthetic version of the GLP-1 agonist exendin-4, which is currently approved for the treatment of type 2 diabetes. In 2017, Invex received orphan drug designation for Exenatide in IIH from the US Food and Drug Administration and European Medicines Agency. About the IIH EVOLVE Clinical Trial The Phase III IIH EVOLVE trial is a randomised, placebo -controlled, double-blind, multi-centre trial that will randomise 240 patients with newly diagnosed IIH to determine the efficacy and safety of Presendin™ versus placebo, administered once weekly. Patients with a confirmed diagnosis of IIH will be randomised on a 1:1 basis to either Presendin™ or placebo for 24 weeks. The primary endpoint of the trial is the change in intracranial pressure (ICP), as measured by lumbar puncture, at baseline and at 24 weeks. Secondary endpoints include the change in perimetric mean deviation (PMD), papilloedema and monthly headache days over 24 weeks. IIH EVOLVE is 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. Further study details can be found at clinicaltrials.gov website under Identifier NCT05347147 or by visiting: https://clinicaltrials.gov/ct2/show/NCT05347147

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