Clinical-stage biopharmaceutical company Invex Therapeutics (ASX: IXC) has announced it has received about £100,000 (A$186,000) in a research and development tax rebate from the UK government for the 2021 financial year.
The rebate relates to research and development activities conducted by its subsidiary Invex UK, including research undertaken in the lead-up to a planned phase three clinical program of its drug Presendin.
Invex is focused on developing and commercialising Presendin for the treatment of neurological conditions relating to raised intracranial pressure.
The tax rebate is part of the UK government’s strategy to encourage investment in innovation in the country. The rebate received by Invex was calculated at 13% of the company’s qualifying research and development expenditure.
Invex executive director Dr Tom Duthy said the receipt of the additional non-dilutive funds reflects the company’s commitment to invest into its core research and development assets with particular emphasis on developing Presendin for idiopathic intracranial hypertension (IIH).
“We anticipate an increase in UK rebates and the commencement of Australian R&D tax rebates in future periods as the company accelerates R&D expenditure necessary to support our important registration directed IIH EVOLVE phase three clinical trial, which is expected to recruit IIH patients in the UK, European Union, Australia and the United States,” Dr Duthy said.
Phase three clinical trial
In early November, Invex confirmed it will proceed with a phase three trial to achieve global registration of Presendin in the treatment of IIH.
The IIH EVOLVE trial will recruit 240 patients across 37 centres in Europe, the UK, Australia and the US who will be randomised to receive either subcutaneous injections of Presendin or a placebo, administered once a week over 24 weeks.
The primary endpoint will assess the mean difference in intracranial pressure from baseline to 24 weeks between patients receiving Presendin and those on placebo.
Secondary endpoints will assess the relative difference in vision (known as perimetric mean deviation and papilloedema) and monthly headache days (MHD) between the two groups over 24 weeks.
Trial steering group chair appointed
Last week, Invex announced it had appointed Professor Michael Wall as the trial steering group chairperson for the IIH EVOLVE trial.
Dr Wall is a Professor of Ophthalmology and Neurology at the University of Iowa College of Medicine and Director of the Iowa Visual Field Reading Centre.
Invex executive director and chief scientific officer Professor Alexandra Sinclair said Professor Wall has a “distinguished career in the field of IIH, has published widely and has significant experience and expertise” in the execution of clinical trials in neurology and ophthalmology for pharmaceutical companies undertaking studies in the US and globally.
“We certainly welcome the opportunity to work with Professor Wall on this important phase three clinical trial in IIH, where approved therapies are lacking,” Professor Sinclair added.