Phase 1 clinical studies for MDI-478: An AMPA receptor positive allosteric modulator for the treatment of cognitive impairment associated with schizophrenia (360G-Wellcome-222159_Z_20_Z)

The funding requested will be used to demonstrate that the AMPAR PAM MDI-478: \- Is safe and well-tolerated. \- Enters the CNS by measuring CSF drug concentrations. \- Has a pharmacokinetic profile suitable for further clinical development. \- Enters the CNS and engages the target (AMPARs) to produce a functional effect as measured either using magnetoencephalography (MEG), functional magnetic resonance imaging (fMRI), mismatch negativity (MMN) and/or cognitive testing. These data will then be used to compile the documentation required to support the use of MDI-478 as a Phase 2-ready drug for the treatment of CIAS. As the project progresses, we will keep potential partners informed such that upon completion of this project, MDI-478 can either be out- licensed or attract the commercial funding required to establish a spin-out and fund the compound through Phase 2 Proof-of-Concept studies. The ultimate aim will therefore be to complete Phase 2 and Phase 3 efficacy studies and achieve the Regulatory Approval required for MDI-478 to be a First-in-Class drug that will treat the CIAS that remains a significant barrier to the full functional recovery of schizophrenia patients.