US-based biotech Longboard Pharmaceuticals has announced positive topline data from the Phase Ib/IIa study investigating LP352 (bexicaserin) to treat patients with developmental and epileptic encephalopathies (DEEs).
The randomised, double-blind, placebo-controlled PACIFIC trial (NCT05364021) enrolled 52 patients with DEEs, evaluating the safety and efficacy of LP352 at doses of 6mg, 9mg and 12mg three times daily versus a placebo.
The primary endpoint of the trial was a median change in countable motor seizure frequency, with patients treated with LP352 showing a 53.3% decrease compared to a 20.8% decrease in the placebo group.
The drug demonstrated favourable safety and tolerability, with 85.7% of patients tolerating the highest dose. All of the participants who completed the study opted for an ongoing open-label extension.
Longboard’s stock price has soared by 316% following the announcement of the results since closing on the last trading day of 29 December 2023.
On the same day as the data announcement, the company also initiated an underwritten public offering to raise $150m through the issuance and sale of its voting common stock.
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Longboard’s CEO Kevin Lind said that the company is continuing with Phase III preparations as it looks at the broader dataset.
In December 2022, Longboard reported data from a Phase I study evaluating pharmacokinetics (PK) and pharmacodynamics (PD) of LP-352 in healthy volunteers. The topline data demonstrated the characterisation of safety and tolerability of doses with titration and taper, and the characterisation of plasma and cerebrospinal fluid (CSF) PK.
According to GlobalData’s Pharmaceutical Intelligence Center, LP352 is forecasted to generate $258m in sales in 2029.
GlobalData is the parent company of Clinical Trials Arena.
LP352 is a drug that targets G protein-coupled receptors (GPCRs), integral membrane proteins involved in cellular signalling. These drugs aim to modulate GPCRs, regulating signalling pathways to manage epilepsy by influencing neuronal activity and reducing seizures.
This marks progress for GPCR drugs, with several other companies in the space. In October 2023, Genentech expanded a deal with Sosei Heptares, following similar deals between the latter and pharma giants AbbVie, Pfizer, and Eli Lilly and . Under the agreement, Sosei Heptares will develop new small molecules and biologics that modulate GPCR targets identified by Genentech.