“These preclinical results demonstrate the potential of BAER-101 to improve the current treatment landscape of epilepsy with a differentiated approach designed to improve the safety profile compared to existing drugs, which are often not well-tolerated due to side effects including sedation, cognitive impairment, ataxia and addiction,” said Alexandra MacLean, M.D., Chief Executive Officer of Avenue. “As we advance toward potentially initiating a Phase 2a study in 2024, we are encouraged by these results, showing BAER-101’s best-in-class potential for patients with increased tolerability, potency and efficacy.” BAER-101 underwent preclinical in vivo evaluation in SynapCell's Genetic Absence Epilepsy Rat from Strasbourg (“GAERS”) model of absence epilepsy. The GAERS model mimics behavioral, electrophysiological and pharmacological features of human absence seizures. The GAERS model is a proven, early, informative indicator of efficacy in anti-seizure drug development, with high predictability of response in humans. In the model, BAER-101 demonstrated full suppression of seizure activity with a minimal effective dose of 0.3 mg/kg, PO. The effect was fast in onset and stable throughout the duration of testing. “As an experienced neurologist treating patients with epilepsy, I believe the potency, tolerability and efficacy of BAER-101 is exciting, as it creates an opportunity to improve the treatment of seizures in a field where many of the approved treatments have limited efficacy and/or are dose-limited by side effects,” said Amy Chappell, M.D., FAAN, experienced neuroscience drug developer, former Eli Lilly and Company executive, and consultant to the Company. The detailed study results are expected to be presented at an upcoming scientific meeting.
Absence epilepsy is a form of epileptic syndrome where patients show generalized non-convulsive seizures characterized by a brief unresponsiveness to environmental stimuli and cessation of activity. In human, typical absence seizures are associated with bilateral, synchronous and regular spike-and-wave discharges (“SWD”). SynapCell's world-exclusive model, the GAERS, displays spontaneous SWD and has become the “state of the art” translational a reference model for the past thirty years. Most of the drugs that have been studied in the GAERS model work in focal as well as generalized seizures in humans. Forward-Looking Statements
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