H. Lundbeck A/S (Lundbeck) today announced that data will be presented for bexicaserin, a novel, highly selective investigational potential treatment in development for seizures associated with Developmental and Epileptic Encephalopathies (DEEs), in poster sessions at the 2024 AES Annual Meeting.

As recently announced, Longboard Pharmaceuticals has been acquired by Lundbeck. Longboard developed bexicaserin and conducted the phase II program, the PACIFIC Study. The acquisition strengthens Lundbeck's late-stage pipeline and advances the ambition of building a neuro-rare franchise.

"Bexicaserin's differentiated and potentially best-in-class profile addresses a significant unmet need in severe epilepsies where few treatments exist. Bexicaserin has achieved Breakthrough Therapy Designation (BTD) for DEEs, as well as Orphan Drug Designation and Rare Pediatric Disease Designation for Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS) from the FDA. The AES Annual Meeting provides a good opportunity to engage with key opinion leaders and advocacy groups and discuss bexicaserin's potential," said Johan Luthman, EVP and Head of Research & Development at Lundbeck.

Presentation & Event Details:
 

Saturday, December 7, 2024, 12:00 - 2:00pm PT:

Title: Bexicaserin's Safety, Tolerability and Efficacy in a Cohort of Participants with Developmental and Epileptic Encephalopathies: Interim Results of a Phase 1b/2a PACIFIC Study Open-Label Extension (OLE)

Poster number: 1.509

Title: Additional Efficacy Analyses of the Bexicaserin PACIFIC Study in Participants with Developmental and Epileptic Encephalopathies: Responder Rates, Number Needed to Treat, and Seizure-Free Days

Poster number: 1.402

Title: Bexicaserin Reduces Seizures and Respiratory Arrest in a Mouse Model of SUDEP

Poster number: 1.505

Title: Bexicaserin Exhibits High Selectivity and Specificity for the 5-HT2C Receptor with Low Potential for Off-Target Activity

Poster number: 1.506

Title: Preliminary Results from a Controlled Study of Sleep Disruption in Caregivers of Individuals with Lennox-Gastaut Syndrome (LGS)

Poster number: 1.531
 

Monday, December 9, 2024, 12:00 -1:45pm PT

Title: Bexicaserin Demonstrates Similar Reduction of Countable Motor Seizures in Adolescents and Adults with Developmental and Epileptic Encephalopathies: Analysis of the Phase 1b/2a PACIFIC Study

Poster number: 3.399

Title: Bexicaserin has Negligible Drug-Drug Interaction Potential with Frequently Used Antiseizure Medications in a Phase 1b/2a Study in Participants with Developmental and Epileptic Encephalopathies

Poster number: 3.400

Title: Cocktail Approach for Assessment of Drug-Drug-Interaction Potential of Bexicaserin as a Perpetrator on the Pharmacokinetics of Substrates for Renal, Hepatic, Efflux Transporters, and CYP/UGT Enzymes

Poster number: 3.401
 

Monday, December 9, 2024, 2:00 - 5:00pm PT

Scientific Exhibit: Bexicaserin: A Novel Serotonergic Medication in Development for the Treatment of Seizures Associated with Developmental and Epileptic Encephalopathies
Location: Room 404 AB, Los Angeles Convention Center

About Bexicaserin
Bexicaserin (LP352) is an oral, centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist with no observed impact on 5-HT2B and 5-HT2A receptor subtypes. It is being evaluated in a global Phase III clinical program (the DEEp Program). The FDA has granted Breakthrough Therapy designation for bexicaserin for the treatment of seizures associated with Developmental and Epileptic Encephalopathies (DEEs) for patients two years of age and older. Bexicaserin is an investigational compound that is not approved for marketing by the FDA or any other regulatory authority.

Contacts

About H. Lundbeck A/S
Lundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases.

Brain disorders affect a large part of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments.

As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole.

Lundbeck has approximately 5,500 employees in more than 50 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us via LinkedIn.