GAERS

Avenue Therapeutics Reports Full Year 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Monday, March 18, 2024
Research, Epilepsy, PO, Seizure, Partnership, Risk, Patient, Tramadol, Acquisition, American Epilepsy Society, GABAA, Enrollment, NRF1, SBMA, Schedule, Hydromorphone, Society, Therapy, DSM-IV codes, Safety, GAERS, Morphine, Pain, FDA, AES, Annual general meeting, Food, Pharmaceutical industry

MIAMI, March 18, 2024 (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 reported financial results and recent corporate highlights for the year ended December 31, 2023.

Key Points: 
  • “We made considerable progress across our pipeline of differentiated neurologic therapies in 2023," said Alexandra MacLean, M.D., Chief Executive Officer of Avenue.
  • Pending additional financing, we look forward to progressing BAER-101 and IV tramadol for patients facing great unmet need.
  • R&D Expenses: Research and development expenses for the full year 2023 were $6.1 million, compared to $2.7 million in 2022.
  • G&A Expenses: General and administrative expenses for the full year 2023 were $4.2 million, compared to $5.3 million in 2022.

Avenue Therapeutics to Present BAER-101 Preclinical Data at American Society for Experimental Neurotherapeutics (ASENT) 2024 Annual Meeting

Retrieved on: 
Monday, March 11, 2024
Receptor (biochemistry), DSM-IV codes, FAAN, GAERS, Safety, Society, PO, Generalized tonic–clonic seizure, Therapy, Patient, Epilepsy, Human, Pharmaceutical industry

MIAMI, March 11, 2024 (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 epilepsy at the American Society for Experimental Neurotherapeutics (ASENT) 2024 Annual Meeting on Wednesday, March 13, 2024.

Key Points: 
  • The Company's presentation details are as follows:
    Title: BAER-101, a Selective Potentiator of α2- and α3-containing GABAA Receptors, Fully Suppresses Spontaneous Cortical Spike-Wave Discharges in Genetic Absence Epilepsy
    BAER-101 underwent preclinical in vivo evaluation in SynapCell's GAERS model of absence epilepsy.
  • 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.

Avenue Therapeutics Announces Publication in Drug Development Research Highlighting First-In-Class Preclinical Data of BAER-101 in a Translational Model of Absence Epilepsy

Retrieved on: 
Thursday, February 22, 2024
Epilepsy, Pharmacology, DSM-IV codes, Research, GABAA, Drug resistance, 300X, Dizziness, Drug development, PAM, Volunteering, GAERS, Risk, Generalized tonic–clonic seizure, Deficit spending, Rat, Therapy, Ataxia, Memory, MED, Human, Cognition, Patient, Somnolence, Addiction, Partnership, Pharmaceutical industry

MIAMI, Feb. 22, 2024 (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 the publication of preclinical in vivo data in Drug Development Research highlighting BAER-101’s full suppression of seizure activity using the Genetic Absence Epilepsy Rats from Strasbourg (“GAERS”) model of absence epilepsy.

Key Points: 
  • MIAMI, Feb. 22, 2024 (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 the publication of preclinical in vivo data in Drug Development Research highlighting BAER-101’s full suppression of seizure activity using the Genetic Absence Epilepsy Rats from Strasbourg (“GAERS”) model of absence epilepsy.
  • The publication describes the extent of anti-seizure activity of BAER-101 in the GAERS model, a widely used and translationally relevant animal model.
  • The study demonstrated full suppression of seizure activity with a minimal effective dose (MED) of 0.3 mg/kg.
  • “The preclinical data published in Drug Development Research demonstrate BAER-101’s ability to fully suppress seizures in the GAERS model, a translational animal model for anti-seizure drug development with a documented high predictability of response in humans.

Avenue Therapeutics to Present at American Epilepsy Society 2023 Annual Meeting

Retrieved on: 
Friday, December 1, 2023
Generalized tonic–clonic seizure, PO, Risk, Epilepsy, AES, American Epilepsy Society, Therapy, Human, GABAA, FAAN, DSM-IV codes, Patient, Safety, Pharmacology, GAERS, Pharmaceutical industry

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.

Key Points: 
  • 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:
    “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.
  • In the model, BAER-101 demonstrated full suppression of seizure activity with a minimal effective dose of 0.3 mg/kg, PO.
  • 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.

Avenue Therapeutics Announces High Potency and Full Efficacy in a Model of Generalized Seizures for its Novel GABA-A Receptor Potentiator, BAER-101, Supporting Phase 2 Clinical Study

Retrieved on: 
Tuesday, August 1, 2023
Epilepsy, DSM-IV codes, Seizure, Generalized tonic–clonic seizure, Human, Deficit spending, PO, Ataxia, AstraZeneca, Eli Lilly, Patient, GAERS, Addiction, Therapy, FAAN, Safety, Pharmaceutical industry, Avenue

The GAERS model mimics behavioral, electrophysiological and pharmacological features of human absence seizures.

Key Points: 
  • 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 combination of safety, tolerability and efficacy in an established translationally relevant epilepsy model support BAER-101’s continued development.