Publication of Invex IIH Phase II Pressure Trial Results
2023-03-13 · Invex Therapeutics Ltd. · original weblink.com.au ↗
Invex Therapeutics Limited │ ABN 29 632 145 334│ Level 2, 38 Rowland St, Subiaco, Perth WA 6008 │ ASX / Media Release 14 March 2023 Invex IIH Phase II ‘Pressure’ Trial Published in the Prestigious Scientific Journal Brain 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 the publication of the Invex Phase II ‘Pressure’ clinical trial , which provid ed initial safety and efficacy of Exenatide in Idiopathic Intracranial Hypertension (IIH) patients. The publication titled “The effect of GLP -1RA exenatide on Idiopathic Intracranial Hypertension: Randomised Clinical Trial” was co-authored by Professor Alex Sinclair, Invex’s Executive Director and Chief Scientific Officer; and Professor of Neurology in the Institute of Metabolism and Systems Research at the University of Birmingham, Honorary Consultant Neurologist at University Hospitals Birmingham NHS Foundation Trust, and Principal Investigator of the Pressure study. Professor Alex Sinclair commented “We are delighted to have been accepted for publication by the prestigious scientific journal Brain. This is a major trial for the rare and debilitating condition IIH that can lead to people, usually women, going blind and suffering disabling daily headaches. There are no current licenced drugs to treat IIH and hence this result is a major step forward for IIH patients. We are delighted to see that the Phase II trial resulted in our treatment group having lower brain pressure both immediately and after 12 weeks and nearly 8 fewer headache days across the 12-week period, and that all the women were able to continue the treatment throughout with few adverse effects. We now hope to see a much larger trial of exenatide to literally ease the pressure for the many people around the world suffering with IIH.” The scientific results of the Pressure trial were released to ASX on 20 May 2020. The Pressure trial was a double-blind, placebo controlled clinical trial of twice per day Exenat ide versus placebo in the treatment of IIH. The primary endpoint of the study was the change in intracranial pressure at 2.5hrs, 24hrs and 12 weeks post drug administration as measured by real -time patient monitoring devices. Secondary outcomes included monthly headache days, headache severity and monthly analgesia days and visual acuity. - ENDS - This release dated 14 March 2023 has been authorised for lodgement to ASX by the Board of Directors of Invex Therapeutics. Invex Therapeutics Limited │ ABN 29 632 145 334│ Level 2, 38 Rowland St, Subiaco, Perth WA 6008 │ 2 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 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.
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