Cadent Therapeutics Announces FDA Clearance of IND Application and Dosing of Subjects of CAD-9303 for Schizophrenia

“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,” stated 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.

“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.”

About Cadent Therapeutics

Cadent Therapeutics is creating therapies for the treatment of movement, mood, and cognitive disorders. The company combines target specificity, patient selection, drug design and optimization, and novel quantitative endpoints to create first-in-class molecules to treat movement and cognitive disorders. Cadent Therapeutics is rapidly advancing its pipeline of positive allosteric modulators within indications including schizophrenia and spinocerebellar ataxia. Successful Phase 2 data in essential tremor was obtained in 2019. The company has an exclusive license and collaboration agreement with Novartis to develop a negative allosteric modulator, now in Phase 2 for the treatment of treatment resistant depression. Investors include Atlas Venture, Cowen Healthcare Investments, Qiming Venture Partners, Access Industries, Clal Biotechnology Industries, Novartis Corporate and Slater Technology Fund. For more information, please visit cadenttx.com.

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