CHARLOTTESVILLE, Va. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Cavion, Inc., a clinical stage biotechnology company developing novel therapeutics for neurological diseases, announced today that their first-in-class T-type calcium channel modulator CX-8998 significantly suppressed seizures in two translational animal models of absence epilepsy. CX-8998 was more effective than the commonly prescribed anti-epileptic drug ethosuximide in reducing absence seizures in Genetic Absence Epilepsy Rats from Strasbourg (GAERS), a highly predictive model of absence epilepsy. In the GAERS rats, CX-8998 showed near complete suppression of seizure activity (99% reduction in both number and cumulative duration of spike wave discharges) at 10 mg/kg, a well-tolerated dose that results in human-achievable drug concentrations. In contrast, ethosuximide suppressed 60% of seizure activity at exposures associated with the optimal human dose. The poster being presented today in the Anticonvulsant and Antiepileptic Therapies Session (289.21) of the Society for Neuroscience Annual Meeting held in San Diego, CA, also described CX-8998’s preclinical efficacy against seizure as tested previously in the WAG/Rij rat model.
“Based on this promising preclinical research, Cavion is conducting T-WAVE, an open-label Phase 2a clinical trial assessing the safety, tolerability and efficacy of CX-8998 in adolescents and adults with absence seizures,” said Margaret Lee PhD, Cavion’s Senior Vice President, Preclinical and Translational Sciences. “T-WAVE will study whether CX-8998 can significantly reduce seizures and improve outcomes for humans who have not achieved satisfactory response to currently available therapies.”
“CX-8998 is one of the most powerful compounds that we have seen in the GAERS model for absence seizures to date – virtually eliminating them. The analysis was conducted using EEG, the most rigorous assessment of seizures possible,” said Corinne Roucard, CEO of SynapCell, exclusive provider of the predictive translational GAERS model for more than 13 years.
About the T-WAVE Study
T-WAVE (ClinicalTrials.gov NCT03406702) is an open-label 15-patient Phase 2a epilepsy clinical trial assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of CX-8998 in adolescents and adults with generalized epileptic syndromes with absence seizures. Efficacy and pharmacodynamics will be evaluated using digital diaries and quantitative ambulatory EEG readings.
About Generalized Epilepsy with Absence Seizures
Generalized epilepsies constitute nearly one third of all epilepsies. While some generalized epileptic syndrome patients with absence seizures respond to first line antiepileptic drugs and have a generally good prognosis, a significant proportion fail to achieve adequate control with existing therapeutics or experience intolerable side effects. For these patients, the goal is to achieve seizure control while limiting side effects and negative impacts, especially on cognitive outcomes.
About Cavion, Inc.
Cavion, Inc. is a privately held clinical stage biotechnology company creating therapies aimed at modulating the T-type calcium channel for the treatment of chronic and rare neurological diseases. Cavion’s portfolio of T-type calcium channel modulators is being developed to restore the brain’s natural rhythms in a variety of neurological diseases such as essential tremor, Parkinson’s disease tremor, neuropathic pain, and epilepsy with absence seizures. Cavion recently announced promising results of their T-CALM proof-of-concept study assessing CX-8998 for essential tremor.
SynapCell is an innovative, brain-focused biotechnology company that provides pharmaceutical companies with a set of predictive solutions designed to evaluate drug candidates’ efficacy on central nervous system disorders. Having first developed its solutions for epilepsy, the company expanded its offerings in 2015 to address motor (Parkinson’s disease) and cognitive (Alzheimer’s disease, autism and schizophrenia) disorders, providing its international clients with Go/No-Go decision capability to progress the discovery of new treatments for CNS disorders.
This press release contains forward-looking statements that are subject to risks and uncertainties and includes statements that are not historical facts. Actual results could differ significantly from results discussed. Cavion, Inc. disclaims any intent or obligation to update forward-looking statements, except as required by law.