First Dose Administered in Phase I Trial of Novel Treatment for Cognitive Impairment Associated with Schizophrenia

February 27, 2023

Simbec-Orion are pleased to share that dosing with MDI-26478, Cardiff University’s Medicines Discovery Institute’s (MDI) potential novel treatment for cognitive impairment associated with schizophrenia and a range of disorders connected with the brain and central nervous system, has commenced in our MHRA Accredited Phase I Unit in South Wales. This is an exciting milestone for Cardiff University’s MDI where the discovery originated, and it is hoped that the eventual outcome will be a therapeutic that will improve brain health for individuals living with schizophrenia and other similar disorders associated with the brain and central nervous system.

The study also brings together two other organisations from South Wales, as not only will neuroimaging be conducted at the Cardiff University Brain Research Imaging Centre (CUBRIC), but Cardiff based niche CRO The Science Behind are performing the EEG assessments in the Phase I unit.  The clinical study in healthy volunteers is funded by the Wellcome Trust and builds on the Medicines Discovery Institute’s preclinical project which was also funded by the Wellcome Trust.

In the UK about 1 in 6 people will seek treatment for mental health conditions during their lifetime. Currently, there are limited treatment options available to manage schizophrenia conditions effectively and so there is an unmet need to develop new treatments which could be more effective. The illness affects men and women alike and sufferers are from all walks of life with a significant impact on the overall quality of life due to the severity of day-to-day symptoms. The Cardiff University MDI team hope that their drug will help patients manage their symptoms more effectively and offer a new and more novel treatment for individuals with these conditions.

Ceri Edwards, Managing Director, Clinical Pharmacology noted “Simbec-Orion are delighted to be supporting Cardiff University’s Medicines Discovery Institute (MDI) and proud to be collaborating with our colleagues across South Wales on this project. It is a fantastic example of how the scientific and drug development network in our region can be utilised to drive promising discoveries towards commercialisation. Discoveries that will ultimately transform the lives of patients living with neurological conditions such as schizophrenia.”

Simbec-Orion is a full-service Contract Research Organisation (CRO) who for the last four decades, have been providing clinical trial management services across a wide range of therapeutic indications and phases. Their MHRA Accredited Phase I Clinical Pharmacology Unit, Laboratories and team of experienced management, clinical research and pharmacology specialists are based in a purpose-built facility in Merthyr Tydfil, Wales, UK.

The Medicines Discovery Institute is the leading, university-based, CNS drug discovery group in Europe, delivering modern drug discoveries to improve treatments for neurological illnesses. Grounded in the academic & clinical excellence of Cardiff University, the team combines profound insight with industry-standard drug discovery. A robust pipeline of novel drug projects stretches from early drug screening through to human clinical trials, run at Cardiff. The Institute is led by Professors Simon Ward & John Atack.

The Science Behind combines neuroscience, neurology and psychology expertise and technology to provide a service that offers an array of electro-diagnostic markers to assess human brain excitability and functionality in health and disease. For those looking to measure target engagement, evaluate in-vivo markers for pharmacological activity and/or in-vivo markers for specific biological processes The Science Behind supports trials with protocol design, delivery, data analysis and reporting.

Wellcome supports science to solve the urgent health challenges facing everyone. We support discovery research into life, health and wellbeing, and we’re taking on three worldwide health challenges: climate and health, mental health, and infectious disease.

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