Cadent Therapeutics announced the U.S. Food and Drug Administration (FDA) has provided clearance to proceed for its Investigational New Drug (IND) application for its lead cognitive disorder asset, CAD-9303, a novel, first-in-class, positive allosteric modulator (PAM) of N-methyl-D-aspartate (NMDA) receptors for the treatment of the cognitive deficits and negative symptoms of schizophrenia. Dosing of patients is now underway in the Phase 1 clinical trial.
“This IND clearance and initiation of dosing represents a critical milestone for Cadent as we progress CAD-9303 forward as the first drug candidate in our psychiatric disorders pipeline,” said Jodie Morrison, Chief Executive Officer. “CAD-9303 serves as the first NMDA PAM to be developed to potentially transform the lives of patients with schizophrenia.”
The Affinity trial is a multicenter, randomized, placebo-controlled study that will evaluate the safety, tolerability, and exploratory efficacy assessments of CAD-9303 in patients with schizophrenia and healthy volunteers. Outcome measures include tests of cognitive function, a standard negative symptom sub-scale, and biomarkers including EEG (electroencephalography) assessment of event-related potentials known to be impaired in patients with schizophrenia.
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“The major unmet need for people living with schizophrenia is the lack of treatments for cognitive deficits and negative symptoms. These are the first symptoms of disease and remain untreated by standard antipsychotic therapy,” said Tim Piser, Chief Scientific Officer, “Clinical neuroscience has strongly implicated NMDA receptor hypofunction in the pathophysiology of schizophrenia, and CAD-9303 may offer the first opportunity to directly address NMDA receptors as a therapeutic approach. We are excited to begin exploring the impact this novel NMDA receptor PAM could have on patient outcomes.”