Generalized tonic–clonic seizure

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

Retrieved on: 
Monday, March 11, 2024

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

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.

Empatica Reveals Next Generation FDA-Cleared Epilepsy Watch and Launches AI Seizure Forecasting Study

Retrieved on: 
Wednesday, February 28, 2024

Empatica, a leader in remote health monitoring powered by AI, is proud to announce the official launch of EpiMonitor , the latest advancement in wearable epilepsy monitoring.

Key Points: 
  • Empatica, a leader in remote health monitoring powered by AI, is proud to announce the official launch of EpiMonitor , the latest advancement in wearable epilepsy monitoring.
  • In December 2023, Empatica also announced plans to conduct a groundbreaking study to develop a seizure forecasting algorithm, based on the world’s largest real-world data set in epilepsy patients.
  • “Our FORESIGHT clinical study is an incredibly exciting opportunity to advance personalized seizure forecasting,” said Dr. Marisa Cruz, Empatica’s Chief Medical Officer.
  • In 2018, Empatica’s Embrace wearable received FDA clearance for seizure monitoring, making it the world's first epilepsy watch to be cleared by the FDA.

Human medicines European public assessment report (EPAR): Vimpat, lacosamide, Date of authorisation: 29/08/2008, Revision: 48, Status: Authorised

Retrieved on: 
Monday, January 8, 2024

Human medicines European public assessment report (EPAR): Vimpat, lacosamide, Date of authorisation: 29/08/2008, Revision: 48, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Vimpat, lacosamide, Date of authorisation: 29/08/2008, Revision: 48, Status: Authorised

Seizures Identified as Potential Cause of Sudden Unexplained Death in Children

Retrieved on: 
Thursday, January 4, 2024

Most are infants in what is referred to as sudden infant death syndrome, or SIDS, but 400 or more cases involve children aged 1 and older, and in what is called sudden unexplained death in children (SUDC).

Key Points: 
  • Most are infants in what is referred to as sudden infant death syndrome, or SIDS, but 400 or more cases involve children aged 1 and older, and in what is called sudden unexplained death in children (SUDC).
  • These seizures lasted less than 60 seconds and occurred within 30 minutes immediately prior to each child's death, say the study authors.
  • For decades, researchers have sought an explanation to sudden death events in children, noticing a link between those with a history of febrile seizures (seizures accompanied by fever).
  • Further research, Devinsky notes, is also needed to determine precisely how seizures with or without fever may induce sudden death.

Human medicines European public assessment report (EPAR): Vimpat, lacosamide, Date of authorisation: 29/08/2008, Revision: 47, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Vimpat, lacosamide, Date of authorisation: 29/08/2008, Revision: 47, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Vimpat, lacosamide, Date of authorisation: 29/08/2008, Revision: 47, Status: Authorised

Neurona Therapeutics Presents New Clinical Data from First Cohort in Ongoing Phase I/II Open-Label Trial of NRTX-1001 Cell Therapy for Drug-resistant Mesial Temporal Lobe Epilepsy (MTLE)

Retrieved on: 
Friday, December 1, 2023

SAN FRANCISCO, Dec. 01, 2023 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a clinical-stage biotherapeutics company advancing regenerative cell therapy candidates for the treatment of neurological disorders, announced presentation of positive preliminary clinical data from the first cohort of five subjects in its ongoing open-label, single-arm Phase I/II clinical trial of NRTX-1001, an investigational allogeneic cell therapy candidate that is being developed for treatment of drug-resistant MTLE. The data will be presented at the Annual Meeting of the American Epilepsy Society, which is being held December 1-5, 2023 in Orlando, Florida.

Key Points: 
  • The data will be presented at the Annual Meeting of the American Epilepsy Society, which is being held December 1-5, 2023 in Orlando, Florida.
  • “The early data from the first cohort in the trial have been very encouraging, with substantial, durable seizure reduction in the first subjects with drug-resistant MTLE.
  • All subjects who received NRTX-1001 in the ongoing clinical trial entered the study with a history of significant monthly seizure activity that was not controlled by anti-seizure medications.
  • No severe adverse events from the cell therapy, delivery procedure, or immunosuppression regimen have been reported thus far in the ongoing clinical trial.

Avenue Therapeutics to Present at American Epilepsy Society 2023 Annual Meeting

Retrieved on: 
Friday, December 1, 2023

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.

Praxis Precision Medicines to Showcase Largest Pipeline of Precision Epilepsy Programs and Breadth of Commitment to Epilepsy Treatments at Upcoming Meetings

Retrieved on: 
Tuesday, November 28, 2023

Presentations at the American Epilepsy Society (AES) Annual Meeting, as well as related scientific and patient advocacy meetings, will cover new patient data, updates on clinical progress and new paradigms for developing epilepsy therapies.

Key Points: 
  • Presentations at the American Epilepsy Society (AES) Annual Meeting, as well as related scientific and patient advocacy meetings, will cover new patient data, updates on clinical progress and new paradigms for developing epilepsy therapies.
  • ET [Platform D | Epilepsy Therapies]
    Summary: Combined preclinical and clinical data demonstrate PRAX-628 is differentiated from standard of care, with the potential to be best-in-class for focal epilepsy.
  • Summary: This study provides novel insights into the clinical validity of commonly used preclinical seizure models across the clinical epilepsy spectrum.
  • Oral presentation highlighting clinical updates from our PRAX-562 small molecule platform at the annual clinician, researcher, and family gathering for SCN8A

Avenue Therapeutics Reports Third Quarter 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Monday, November 13, 2023

MIAMI, Nov. 13, 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 reported financial results and recent corporate highlights for the third quarter ended September 30, 2023.

Key Points: 
  • “In the third quarter, Avenue continued to successfully execute across our pipeline of innovative CNS treatments," said Alexandra MacLean, M.D., Chief Executive Officer of Avenue.
  • Topline data for the Phase 1b/2a clinical trial of AJ201 in SBMA are expected in the second quarter of 2024.
  • R&D Expenses: Research and development expenses for the third quarter of 2023 were $0.9 million, compared to $0.2 million for the third quarter of 2022.
  • G&A Expenses: General and administrative expenses for the third quarter of 2023 were $1.2 million, compared to $0.5 million for the third quarter of 2022.