IIH EVOLVE

Pivotal Phase III Clinical Trial of Presendin™ (Sustained-Release Exenatide) versus placebo in Idiopathic Intracranial Hypertension (IIH)

Trial Steering Committee Chairperson –
Professor Michael Wall

Michael Wall, M.D. is a professor of Neurology and Ophthalmology at the University of Iowa. His undergraduate and medical school education was at Tulane University, his neurology residency at Washington University in St. Louis and his fellowship at Harvard University. As a neuro-ophthalmologist he is involved in patient care, teaching and research. He is the author of 124 peer-reviewed journal articles and three books. He has been involved in idiopathic intracranial hypertension research for 30 years and was the Study Director of the NIH funded Idiopathic Intracranial Hypertension Treatment Trial. He had consecutive funding for over 25 years through the VA Merit system. This research focused on the development of new and improved perimetric methods and strategies and mechanisms of perimetric variability. He is the director of the Iowa Visual Field Reading Center, established in 2008. The reading center features a fully digital secure system. Its goal is to provide researchers with a means to access and evaluate both raw and processed visual field data and to provide timely feedback to researchers and clinicians. The reading center has been involved in successfully completing 12 clinical trials involving both the NIH and pharma.

Trial Steering Committee Member –
Associate Professor Clare Fraser

Associate Professor Fraser trained at Sydney Eye Hospital, and did fellowships at Moorfields Eye Hospital (London, UK) and Emory Eye Center (Atlanta, USA). She has specialised in neuro-ophthalmology, strabismus and visual electrodiagnostics. She is a consultant Visiting Medical Officer at both Sydney Eye Hospital and Liverpool Hospital and is also in private practice in Sydney. At the University of Sydney, she holds the title of Associate Professor of Neuro-ophthalmology. Dr Fraser served as Vice President of The Neuro-Ophthalmology Society of Australia, is Chair of the North American Neuro-Ophthalmology Society International Committee and is on the committee for the Neuro-Ophthalmology Virtual Education Library and on the editorial boards for several high impact ophthalmology journals.

Trial Steering Committee Member –
Professor Patricia Pozo-Rosich

Professor Pozo-Rosich is a Head of Section in the Neurology Department at Vall d’Hebron University Hospital in Barcelona and Director of the Migraine Adaptive Brain Centre. Professor Pozo-Rosich is also Coordinator of the Brain, Mind & Behaviour eCORE and in charge of the Headache Research Laboratory at the Vall d’Hebron Institute of Research. Professor Pozo-Rosich is the Honorary Secretary of the International Headache Society and a Scientific Advisory Board member of the Lilly Foundation in Spain. She is the Editor for Headache for Revista de Neurologia, and Associate Editor of Cephalalgia, Headache, Neurologia, Frontiers in Neurology (Headache Medicine) and a member of the Editorial Advisory Board of The Journal of Headache and Pain.

Trial Steering Committee Member –
Professor Susan Mollan

Professor Mollan is Honorary Professor at the University of Birmingham and a Consultant Neuro-ophthalmologist at University Hospitals Birmingham (UHB), in the United Kingdom. She is the Director of Ophthalmology Research and the Data Officer for INSIGHT (a Health Data Research UK hub for eye health) at UHB. She is an International Senior Examiner for the Royal College of Ophthalmologists and an active committee member at the North American Neuro-Ophthalmology Society.  She is a key opinion leader in IIH and was the lead author of the IIH consensus guidelines (2018); and the European Headache Federation IIH guidelines (2019).

Trial Steering Committee Member –
Professor Helen Danesh-Meyer

Professor Danesh-Myer is Professor, Faculty of Medical and Health Sciences, Ophthalmology and holds the Sir William and Lady Stevenson Chair in Ophthalmology and Head of Academic Neuro-ophthalmology and Glaucoma, University of Auckland and Director of the Eye Institute. She heads the Optic Nerve Research Unit which is involved in translational research investigating the role of neuroinflammation in optic nerve and retinal injury. She is also recognized internationally for her pioneering work on the role of ocular imaging in neuro-ophthalmology. Professor Danesh-Meyer is an international authority in glaucoma and neuro-ophthalmology.

Trial Steering Committee Member –
Professor Dr Wolf Lagrèze

Professor Lagrèze is Professor of Ophthalmology at the University Medical Center Freiburg, Germany, where he holds the Chair of Neuro-ophthalmology and Pediatric Ophthalmology. He studied Medicine at the University of Frankfurt and did his MD thesis at the Max Planck-Institute for Brain Research, Frankfurt. Dr Lagrèze directs the Interdisciplinary Center for Orbital Diseases at the same institution and has a strong research interest in pediatric ophthalmology, neuro-ophthalmology and orbital diseases.

Thank you for your interest in the Invex Therapeutics IIH EVOLVE Phase III Clinical Study.  To contact us please see our advice below:

IIHEVOLVE@invextherapeutics.com

This email address should be used by healthcare professionals either with an interest in or already working on Invex’s phase III IIH-EVOLVE clinical study.   Please note that all information on ongoing clinical trials including eligibility criteria and contact information are posted on the https://clinicaltrials.gov/ website under ClinicalTrials.gov Identifier: NCT05347147.

For IIH patient enquiries:

Please do not send us any information regarding your condition.

Should you want to see if you could be eligible for our IIH-EVOLVE study you can find more information and contact suggestions at https://clinicaltrials.gov/ct2/show/NCT05347147

Alternatively, you could contact your healthcare provider or find more information regarding your condition from patient organisations in your country of residence, for example:

For the UK – https://www.iih.org.uk/
For Australia – https://headacheaustralia.org.au or http://www.ihaustralia.org.au

For General Corporate or Investor enquiries:

info@invextherapeutics.com

This email address is for all queries regarding Corporate or Investor matters only.