Longboard Pharmaceuticals Receives Breakthrough Therapy Designation for Bexicaserin (LP352)
-Longboard Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, today announced that the FDA has granted Breakthrough Therapy designation for its investigational drug bexicaserin for the treatment of seizures associated with Developmental and Epileptic Encephalopathies (DEEs) for patients two years of age or older.
“The FDA will work closely with us to provide guidance on subsequent development of bexicaserin to help us design and conduct a development program as efficiently as possible. We are looking forward to initiating our global Phase 3 program later this year.We are thrilled to receive Breakthrough Therapy designation for bexicaserin and believe this important milestone underscores our innovative approach to potentially treating a broad range of DEE patients,” stated Dr. Randall Kaye, Longboard’s Chief Medical Officer.
“I am excited about what this designation means for the DEE community. Most of those living with DEEs do not have access to novel medications, nor have they had the opportunity to participate in trials designed to collect data specific to their condition. I am thrilled that we are making strides towards advancing DEE research for the broader population and pleased that there is a move towards increased equity and access for underserved patients and families to clinical trials and potential novel treatments,” stated Gabrielle Conecker, MPH, Executive Director & Co-Founder of Decoding Developmental Epilepsies, home of the International SCN8A Alliance, DEE-P Connections, and The Inchstone Project.
Breakthrough Therapy designation is a process designed to expedite the development and regulatory review of drugs that are intended to treat serious or life-threatening conditions and preliminary clinical evidence indicates that the drug may demonstrate a substantial improvement over available therapy on at least one clinically significant endpoint. A drug that receives Breakthrough Therapy designation is eligible for more intensive guidance on an efficient drug development program and organizational commitment involving senior managers from the FDA.
Bexicaserin and LP659 are investigational compounds that are not approved for marketing by the FDA or any other regulatory authority.
July 5, 2024
