LA JOLLA, Calif.--(BUSINESS WIRE)--Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, today announced that it will host a conference call to discuss topline data from the PACIFIC Study, a Phase 1b/2a clinical trial evaluating bexicaserin (LP352) in participants with a broad range of Developmental and Epileptic Encephalopathies (DEEs). Bexicaserin is a potentially best-in-class, oral, novel, 5-HT2C receptor superagonist with no observed impact on 5-HT2B and 5-HT2A receptor subtypes.
Conference Call and Webcast Details
Longboard will host a conference call tomorrow, January 2, at 8:30am ET. Stockholders and other interested parties may participate in the call by following the instructions below. The live webcast can be accessed on the Events & Presentations portion of the investor page of Longboard’s website at https://ir.longboardpharma.com. A replay will be available on Longboard’s website shortly after completion of the event and will be archived for up to 30 days.
Participant Webcast Link: https://edge.media-server.com/mmc/p/sqg9yxpf
Participant Call Link: https://register.vevent.com/register/BIb92b4a3dd66f44fdbc3fcd202fca9caf
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Click on the call link and complete the online registration form. |
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Upon registering you will receive the dial-in info and a unique PIN to join the call as well as an email confirmation with the details. |
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Select a method for joining the call; |
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i. Dial-In: A dial in number and unique PIN are displayed to connect directly from your phone. |
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ii. Call Me: Enter your phone number and click “Call Me” for an immediate callback from the system. The call will come from a U.S. number. |
ABOUT BEXICASERIN (LP352)
Bexicaserin is an oral, centrally acting, 5-HT2C superagonist in development for the potential treatment of seizures associated with DEEs such as Lennox-Gastaut syndrome, Dravet syndrome, SCN2A-related epilepsies, CDKL5 deficiency disorder, and other epileptic disorders. Bexicaserin is designed to modulate GABA and, as a result, suppress the central hyperexcitability that is characteristic of seizures. Bexicaserin has novel chemistry and attributes, and was designed to be highly specific and selective for the 5-HT2C receptor subtype, giving it the potential to reduce seizures in patients with DEEs while overcoming the known or perceived safety limitations of available drugs in the 5-HT2 class.
ABOUT THE PACIFIC STUDY
The PACIFIC Study is a Phase 1b/2a double-blind, placebo-controlled clinical trial to assess the safety, tolerability, efficacy and pharmacokinetics of bexicaserin (LP352) in 52 participants between the ages of 12 and 65 years old at 34 sites across the U.S. and Australia. Following a 5-week screening period and baseline evaluations, study participants initiated a dose titration over a 15-day period and subsequently continued on the highest tolerated dose throughout the maintenance period of 60 days. Following the maintenance period, participants were then titrated down and eligible participants were given the opportunity to enroll in a 52-week open-label extension program. The primary efficacy measure is median percent change from baseline in countable motor seizure frequency over the 75-day treatment period.
ABOUT LONGBOARD PHARMACEUTICALS
Longboard Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases. Longboard is working to advance a portfolio of centrally acting product candidates designed to be highly selective for specific G protein-coupled receptors (GPCRs). Longboard’s small molecule product candidates are based on more than 20 years of GPCR research. Longboard is evaluating bexicaserin (LP352), an oral, centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist with no observed impact on 5-HT2B and 5-HT2A receptor subtypes. Bexicaserin is currently in a Phase 1b/2a clinical trial, the PACIFIC Study, evaluating participants ages 12 to 65 years old with a broad range of Developmental and Epileptic Encephalopathies (DEEs), including Dravet syndrome, Lennox-Gastaut syndrome and other DEEs. Longboard is also evaluating LP659, an oral, centrally acting, next-generation sphingosine-1-phosphate (S1P) receptor subtypes 1 and 5 modulator, which is in development for the potential treatment of rare neuroinflammatory conditions in a Phase 1 single-ascending dose (SAD) clinical trial in healthy volunteers.
FORWARD-LOOKING STATEMENTS
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. In some cases, you can identify forward-looking statements by words such as “to be held”, “focused on”, “will”, “potential”, “may”, “after”, “emerging”, “opportunity”, “expected”, “designed to”, “working to”, or the negative, plural or other tenses of these words or other comparable language, and they include, without limitation, statements about the following: Longboard’s planned conference call and webcast; bexicaserin (LP352), including its potential to be best-in-class, its potential to treat seizures associated with a broad range of DEEs, and its selectivity, design, chemistry, and attributes; and Longboard’s clinical and preclinical programs and product candidates, ability to develop product candidates and deliver medicines, and focus. For such statements, Longboard claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Longboard’s expectations. Factors that could cause actual results to differ materially from those stated or implied by Longboard’s forward-looking statements include, but are not limited to, the following: topline data may not accurately reflect the complete results of a particular study or trial and remain subject to audit, and final data may differ materially from topline data; PACIFIC Study participants’ diagnoses are as of time of screening and are subject to change; risks related to Longboard’s limited operating history, financial position and need for additional capital; Longboard will need additional managerial and financial resources to advance all of its programs, and you and others may not agree with the manner Longboard allocates its resources; risks related to the development and commercialization of Longboard’s product candidates; Longboard’s product candidates are in the early phases of a lengthy research and development process, the timing, manner and outcome of research, development and regulatory review is uncertain, and Longboard’s product candidates may not advance in research or development or be approved for marketing; enrolling participants in Longboard’s ongoing and intended clinical trials is competitive and challenging; nonclinical and clinical data is voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Longboard or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; macroeconomic events stemming from the COVID-19 pandemic or evolving geopolitical developments such as the conflicts in Ukraine and the Middle East, including but not limited to the impact on Longboard’s clinical trials and operations, the operations of Longboard’s suppliers, partners, collaborators, and licensees, and capital markets, which in each case remains uncertain; risks related to unexpected or unfavorable new data; risks related to principal stockholders or management selling some or all of their stock; risks related to relying on licenses or collaborative arrangements; other risks related to Longboard’s dependence on third parties; competition; product liability or other litigation or disagreements with others; government and third-party payor actions, including relating to reimbursement and pricing; risks related to regulatory compliance; and risks related to Longboard’s and third parties’ intellectual property rights. Additional factors that could cause actual results to differ materially from those stated or implied by Longboard’s forward-looking statements are disclosed in Longboard’s filings with the Securities and Exchange Commission (SEC). These forward-looking statements represent Longboard’s judgment as of the time of this release. Longboard disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
