First Phase schizophrenia clinical trial completes initial studies successfully

A potential new treatment for schizophrenia developed by Cardiff University’s Medicines Discovery Institute has successfully completed the first phase (single ascending dose) of a Phase 1 clinical trial.

The drug - MDI-26478 – is a positive allosteric modulator of the AMPA receptor, believed to play a key role in brain health.

Cognitive decline is a core element of schizophrenia and current treatments fail to treat this effectively. The Cardiff team expects MDI-26478 to enhance cognitive performance, focused initially on schizophrenia.

The drug has been invented by the MDI team and this study marks a major milestone, completing the ‘bench to bedside’ journey.

Dr Jennifer Swettenham, who has led the clinical trial on behalf of the Medicines Discovery Institute, said, ‘We are delighted that MDI-26478 has completed our initial studies and has been shown to be safe at all doses. We are focused on completing the remainder of the study

Professor Simon Ward, Director of Cardiff University’s Medicines Discovery Institute, said: “This is the first step of the journey towards developing this treatment. We hope to have initiated an exciting leap forward in the way we will treat schizophrenia in the future.”

The project has drawn on existing healthcare and drug development expertise across South Wales to accelerate the investigation of this drug. The clinical study will run in Merthyr Tydfil, at Simbec-Orion's MHRA Phase I Accredited Unit.

Neuroimaging studies will take place in tandem at Cardiff University Brain Research Imaging Centre (CUBRIC), and neurophysiological screening and monitoring will be provided by The Science Behind, a Cardiff-based Clinical Trial Research Service.

The research and clinical study have been funded by Wellcome. Participants for the trial will be recruited directly through Simbec-Orion.

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.

Cardiff University Brain Research Imaging Centre is a world-leading centre for measuring pharmacological effects with magnetoencephalography (pharmaco-MEG) and MRI. CUBRIC hosts cutting-edge brain scanning facilities and is an internationally renowned site for innovation in neuroimaging methods and best practice.