CAMBRIDGE, Mass., January 23, 2020 – Cadent Therapeutics, a clinical stage biopharmaceutical company focused on the development of therapies to improve the lives of patients with movement, mood, and cognitive disorders, today announced the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to initiate a Phase 2 clinical trial for CAD-1883, a novel, first-in-class, positive allosteric modulator (PAM) of SK channels (calcium-sensitive potassium ion channels) for the treatment of spinocerebellar ataxia (SCA).
“The FDA acceptance of our second IND application for CAD-1883 signifies another important milestone for Cadent” stated Jodie Morrison, Chief Executive Officer, “With our clinical proof of concept (POC) data in hand for the SK channel, we now look forward to driving to Phase 2 efficacy data in our lead indication of SCA, where no current approved therapies exist for this underserved population.”
Spinocerebellar ataxia is an inherited genetically defined movement disorder. It is characterized by increasing problems with coordination that often affect the legs, hands and speech. More than 30 subtypes of SCA have been described.
“The ability to test a therapeutic with the potential to provide symptomatic benefit is a critical advancement for patients,” said Christopher Kenney, M.D., Chief Medical Officer. “We are pleased to provide participating patients with this promising new treatment and are looking forward to initiating our Phase 2 trial.”
The Phase 2 trial is a multicenter, randomized, placebo-controlled study that will evaluate the safety and efficacy of CAD-1883. Efficacy outcome measures include change from baseline in the Scale for the Assessment and Rating of Ataxia (SARA) and multiple objective biomarker measures through twelve weeks following oral administration of CAD-1883 compared to placebo.