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news.Cavion announced that the first patient has been enrolled in its new T-CALM Study (Tremor Cav3 Modulation Study), a Phase 2 clinical trial using the company’s T-type calcium channel modulator CX-8998 for patients with Essential Tremor (ET).
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Movement disorders like Essential Tremor are associated with abnormal activity of the brain’s neural networks. T-type calcium channels, called Cav3, control the firing and signaling between neurons.
CX-8998 is an oral drug that was designed to selectively modulate these calcium channels, restoring the brain’s natural rhythms. Data from preclinical models suggest that CX-8998 reduces tremor by regulating abnormal neural activity in relevant brain regions.
“We are excited to enroll the first patient with Cavion’s first-in-class agent for movement disorders,” said Cavion CEO and President Andrew Krouse.
“We believe that Cavion’s new therapy may significantly improve the quality of life of people with Essential Tremor, offering hope to them and their families,” added Spyros Papapetropoulos, Cavion's Executive Vice President of Research & Development and Chief Medical Officer.
“There is a tremendous need for new, safe, and effective treatments for essential tremor. The International Essential Tremor Foundation (IETF) is pleased to see a promising new approach studied in such a robust clinical trial for people with essential tremor,” said Foundation Executive Director Patrick McCartney.
T-CALM is a multi-center randomized, double-blind, placebo-controlled study designed to assess the efficacy of CX-8998 in reducing tremors and improving quality of life. The study will enroll up to 92 patients at 18 medical research centers across the United States.
The study will utilize a combination of standard clinical trial scales and state-of-the-art digital biomarkers to objectively quantify tremor. The effect of CX-8998 on neuronal networks will be further explored in a planned sub-study using electrophysiological measures.
Essential Tremor is the most common movement disorder and causes progressively disabling rhythmic trembling of the hands, head, voice, legs or trunk. ET affects an estimated 10 million Americans of all ages and millions more worldwide.