Avenue Therapeutics to Present at American Epilepsy Society 2023 Annual Meeting
- BAER-101 showed full suppression of seizure activity in the GAERS model with a minimal effective dose of 0.3 mg/kg, PO
- The molecule selectively targets GABAA α2 and α3 subtypes, potentially improving anticonvulsant and anxiolytic activity while minimizing the risk of tolerance and abuse
- The safety and tolerability of BAER-101 in hundreds of patients support its continued development in a Phase 2a trial
- None.
MIAMI, Dec. 01, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Amy Chappell, M.D., FAAN, will be presenting preclinical in vivo data evaluating BAER-101 using the SynapCell's Genetic Absence Epilepsy Rat from Strasbourg (“GAERS”) model of absence epilepsy at the American Epilepsy Society (AES) 2023 Annual Meeting in Orlando, FL on December 2, 2023.
The Company's presentation details are as follows:
Title: A Phase 2- Ready Potentiator of α2/3-Containing GABAA Receptors Potently and Fully Blocks Seizures in Rats with Genetic Absence Epilepsy
Poster Session and Location: Session 1; West Hall C, Level 2
Session Date/Time: Saturday, December 2, 2023, 12:00 p.m. ET
Board Number: 1.444
“We are pleased with the progress made with BAER-101, a molecule with unique pharmacology which has demonstrated that it can significantly suppress seizures in a translational animal model of absence epilepsy,” said Alexandra MacLean, M.D., Chief Executive Officer of Avenue. “The presentation of preclinical results from this trial showcase BAER-101’s selectively targeting of GABAA α2 and α3 subtypes more than α1 and α5, potentially improving anticonvulsant and anxiolytic activity while minimizing the risk of tolerance and abuse associated with existing treatments in this drug class. With these compelling preclinical results in-hand, along with the drug’s proven safety profile in numerous clinical trials, we are encouraged by BAER-101’s potential to address the unmet needs of epilepsy patients.”
BAER-101 underwent preclinical in vivo evaluation in SynapCell's Genetic Absence Epilepsy Rat from Strasbourg (“GAERS”) model of absence epilepsy. The GAERS model, which is a proven, early, informative indicator of efficacy in anti-seizure drug development with high predictability of response in humans, mimics behavioral, electrophysiological and pharmacological features of human absence seizures. 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. The combination of safety and tolerability in hundreds of patients and the preclinical efficacy data support BAER-101’s continued development in a Phase 2a trial.
The Company’s poster at AES 2023 will be available on the Publications section of Avenue’s website at https://avenuetx.com/publications/.
About BAER-101
Avenue is developing BAER-101 via its subsidiary Baergic Bio for epilepsy disorders. BAER-101 is a positive allosteric modulator of α2,3 subunit‐containing GABAA receptors with minimal activity at α1 or α5‐containing receptors, which are believed to mediate many of the issues impacting the medical use of benzodiazepines such as those noted with diazepam use (tolerance, dependence, abuse, sedation and impaired cognition). As a result, BAER-101 may have the potential to treat epilepsy, anxiety and other disorders in which benzodiazepines are currently used, while minimizing the benzodiazepine associated adverse effects. BAER-101 was licensed in from AstraZeneca with a large safety database in over 700 patients and an efficacy signal in a subset of patients with anxiety.
About Epilepsy
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 reference model for the past thirty years. Most of the drugs that have been studied in the GAERS model show efficacy in focal as well as generalized seizures in humans.
About Avenue Therapeutics
Avenue Therapeutics, Inc. (Nasdaq: ATXI) is a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases. The Company is currently developing three assets including AJ201, a first-in-class asset for spinal and bulbar muscular atrophy, BAER-101, an oral small molecule selective GABAA α2/3 receptor positive allosteric modulator for CNS diseases, and IV tramadol, which is in Phase 3 clinical development for the management of acute postoperative pain in adults in a medically supervised healthcare setting. Avenue is headquartered in Miami, FL and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.avenuetx.com.
Forward-Looking Statements
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Contact:
Jaclyn Jaffe
Avenue Therapeutics, Inc.
(781) 652-4500
ir@avenuetx.com
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