speaker
Operator
Conference Operator

Good afternoon, ladies and gentlemen, and welcome to the Longboard Pharmaceutical Earnings Incorporate update call. As a reminder, this conference call is being recorded. I would now like to turn the call over to Brandi Roberts, Longboard's Chief Financial Officer. You may begin.

speaker
Brandi Roberts
Chief Financial Officer

Thank you, and good afternoon, everyone. Welcome to Longboard's conference call and webcast, where we'll be providing a corporate update, including results from our LP659 Single Ascending Dose Study. Before we begin today, I would like to remind everyone that this conference call and webcast will contain forward-looking statements about the company, including, without limitation, statements about the potential of our product candidates, the anticipated timing and design of clinical trials, top-line data, commercial opportunities, and financial guidance. These statements are subject to risks and uncertainties that could cause actual results to differ. Factors that could cause actual results or outcomes to differ materially from those expressed in or implied by such forward-looking statements are discussed in greater detail in our most recent report filed with the SEC. Please note that these forward-looking statements reflect our opinions only as of the date of this call, and we undertake no obligation to revise or publicly release the results of any revisions to these forward-looking statements in light of new information or future events. With that, I'll hand the call over to Kevin Lind, Longboard's President and CEO. Kevin?

speaker
Kevin Lind
President and Chief Executive Officer

Thanks, Brandy. And thank you very much to everyone joining us today during what is a very exciting time for Longboard. I'm extremely proud of what we have accomplished in 2024 across the entire organization and portfolio. I'm going to start off by providing an update on our lead asset, Bexacacerin, a highly selective and specific 5-HT2C receptor agonist, and then hand it over to Dr. K to provide an update on LP659. And then Brandy will give an update on our financials before we opened the call for Q&A. We kicked off the year with a positive top-line data from our Phase 1b-2a Pacific study evaluating bexacastrin in developmental and epileptic encephalopathies, or DEEs. We were incredibly pleased that bexacastrin achieved a median reduction of countable motor seizures of approximately 60% in highly refractory participants. And on top of three to four other anti-seizure medications, in Druvet, Lennox-Gesto, and a number of other DEE participants. Then in June, we had a very busy month. First, we shared an interim analysis of our open-label extension study of Pacific, demonstrating a sustained response over an approximate six-month period with continued favorable safety and tolerability, as well as successful titration of all of our placebo participants onto Bexacastrin. Second, we completed our end of phase two meeting. And third, the FDA granted breakthrough therapy designation for seizures associated with DEEs down to the age of two. We are the first and only company to receive this designation for DEEs. The Pacific Data and Breakthrough Therapy designation have been the most rewarding achievements since the founding of Longboard. Both of these support our thesis and strengthen what we believe we have been working towards which is to treat DEEs broadly and provide more equitable access to patients that are tremendously underserved. We have been overwhelmed by the outpouring of excitement and support from caregivers, advocates, and physicians. We're committed to making a difference for those living with DEEs. To that end, we are moving forward with our innovative design to study all DEEs in our global phase three program. We are so pleased to have the opportunity to collaborate with the FDA with the goal of addressing the tremendous unmet medical need for this population in an optimized manner. We're expeditiously preparing to start our phase three program, which will include two pivotal studies, one for Dravet syndrome and one DEE study that will include Lennox-Gastaut and all the other DEEs. We intend to initiate our phase three program in the second half of this year, and we'll provide additional details on the studies at an upcoming investor and analyst day on September 16th. With that, I'd like to switch over to our second clinical stage asset, LP659, a highly selective S1P1-5 receptor modulator. LP659 was created and optimized by ARENA's world-class GPCR research team, the same team that discovered Atrazimod. LP659 was designed to be a centrally acting S1P receptor modulator with some of the same differentiating characteristics built into a TRASMOD. S1P receptor modulators are considered well understood, and early data has been shown to be generally predictive of clinical effectiveness. We have been doing a lot of translational work here. That, coupled with additional learnings from the INI space, has opened up several orphan CNS indications that we think could be very interesting and have attractive commercial opportunities. LP659 works centrally to modulate S1P receptors, which play a crucial role in the immune and nervous systems. It exhibits a rapid onset and offset of action, making it potentially more effective and manageable in clinical settings. Its high selectivity to S1P1 and S1P5 receptors minimizes off-target effects, enhancing its therapeutic profile, and preclinical studies have shown no significant impact on S1P2 and P3, indicating a targeted approach. LP659 has high oral bioavailability, meaning it is effectively absorbed when taken orally, and it directly impacts CNS glial cell S1P receptors. It has shown promising results in preclinical models for various conditions. The market for S1P receptor modulators is substantial, with these treatments already generating significant revenue in CNS and applications, primarily in multiple sclerosis. In multiple sclerosis mouse models, LP659 demonstrated lymphocyte modulation, suggesting its potential efficacy in similar human conditions. However, based on advancements in our understanding of S1Ps, we believe that LP659's unique properties provide it with the potential to be a best-in-class CNS-focused S1P addressing a range of orphan neurological disorders. With that, I'll turn it over to Randall.

Disclaimer

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