Cadent Therapeutics announced the U.S. FDA has accepted its Investigational New Drug (IND) application to initiate a Phase 2 clinical trial for CAD-1883 in patients with Spinocerebellar Ataxia.
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.
In preclinical disease models, CAD-1883 has demonstrated the ability to regulate neuronal firing, improve motor control and reduce tremor. CAD-1883 is completed a Phase 1 dose escalation trial and has been well-tolerated at all doses with only mild, transient adverse effects observed to date. A Phase 2 trial has been completed in essential tremor and a signal was observed. Responder profile analysis from this trial are on-going.
CAD-1883 is a first-in-class selective positive allosteric modulator of SK channels (small conductance, calcium-activated potassium ion channels). SK channels are expressed throughout the central nervous system and are responsible for regulating the amount of potassium that enters a cell and affect the inherent excitability of neurons and communication between synapses. Through SK channel modulation, Cadent Therapeutics aims to control the firing rate (amount of times a neuron fires at any given time) and the firing pattern (allocation of firing over time), thereby restoring balance to the brain’s rhythms.
About Spinocerebellar ataxia
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.Source: Cadent Therapeutics