Longboard Pharmaceuticals, Inc. announced that it has completed enrollment of its Phase 1b/2a clinical trial, the PACIFIC Study, which is evaluating LP352, an oral, centrally acting 5-HT2C receptor superagonist, in 52 participants with Developmental and Epileptic Encephalopathies (DEEs). The PACIFIC Study data are expected to inform the design and characteristics of the planned Phase 3 program for LP352. Participants who complete the PACIFIC Study are eligible to roll over into the ongoing open-label extension (OLE) trial should they choose to do so.

The PACIFIC Study is a Phase 1b/2a clinical trial evaluating participants with Developmental and Epileptic Encephalopathies (DEEs). The primary objectives of the study are to assess the safety and tolerability of LP352. The PACIFIC Study will also evaluate change in seizure frequency over the treatment period.

The study enrolled 52 participants with a variety of treatment resistant seizures that fall into the category of DEE across approximately 30 study sites in the United States and Australia. The PACIFIC Study data are expected to inform the design and characteristics of the planned Phase 3 program for LP352. Participants who complete the PACIFIC Study are eligible to roll over into the ongoing open-label extension (OLE) trial should they choose to do so.

The OLE is a Phase 2 multicenter, open-label, multiple-dose, long-term extension clinical trial designed to evaluate long-term safety of LP352 in participants with DEEs who have completed the PACIFIC Study. DEEs refer to a group of severe heterogeneous epilepsies that are characterized by drug resistant seizures and significant developmental delay. Importantly, if seizure control can be improved, developmental delay may slow.

Most DEEs begin early in life, often starting in infancy. Children can have frequent and severe seizures which may be of multiple types. Epileptic spasms, tonic or atonic seizures and myoclonic seizures, among other seizure types, can be seen.

In many cases, seizures are life long, although in some instances they can abate with time with certain syndromes or specific causes.