Longboard Pharmaceuticals, Inc. LBPH announced positive top-line results from the early to mid-stage PACIFIC study evaluating its lead investigational candidate, bexicaserin (LP352), for the treatment of seizures associated with a broad range of Developmental and Epileptic Encephalopathies (DEEs).

Bexicaserin is Longboard Pharma’s potentially best-in-class and highly selective, oral, novel 5-HT2C receptor superagonist, which is being developed for DEEs. Participant DEE diagnoses included DS, LGS and other qualifying DEEs (DEE Other).

Per the data readout from the study, evaluable patients treated with bexicaserin experienced a median reduction of 53.3% in the countable motor seizure frequency from baseline compared with a 20.8% decrease for those receiving placebo. This comprised the primary efficacy endpoint of the PACIFIC study.

The company also reported the achievement of a median seizure reduction of 72.1%, 48.1% and 61.2% in DS, LGS and DEE Other cohorts, respectively.

Longboard Pharma’s stock skyrocketed 316.3% in the last trading session as the investors cheered the encouraging top-line results from the PACIFIC study of bexicaserin for the treatment of seizures associated with DEEs. Over the past year, shares of LBPH have rallied 395.1% against the industry’s 11.9% fall.

Image Source: Zacks Investment Research

The phase Ib/IIa PACIFIC study is evaluating the safety, tolerability, efficacy and pharmacokinetics of thrice-daily, three doses of bexicaserin (6 mg, 9 mg and 12 mg) in 52 patients aged between 12 and 65 years compared with placebo. All enrolled patients eventually received the highest tolerated dose of bexicaserin.

In the study, bexicaserin demonstrated a favorable safety and tolerability profile. Although there were a few discontinuations in the bexicaserin group due to an adverse event, most participants completed the PACIFIC study. Per Longboard Pharma, all patients who completed the PACIFIC Study elected to enroll in the ongoing 52-week open-label extension study.

The company plans to share additional data from the study at an upcoming medical conference. LBPH plans to advance bexicaserin into global phase III development.

However, it is important to note that there are other players in the market developing novel therapies for various epilepsy indications, an example being Xenon Pharmaceuticals XENE. Xenon is currently developing its lead candidate, XEN1101, in late-stage development for treating focal onset seizures (FOS). Under the phase III epilepsy program, two identical phase III studies, X-TOLE2 and X-TOLE3, are currently evaluating XEN1101 (15 mg or 25 mg) as an adjunctive treatment in patients with FOS.