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Supernus Announces Promising Interim Data from Ongoing Open-Label Phase 2a Study of SPN-817 in EpilepsySPN-817 is a novel, first-in-class highly selective acetylcholinesterase (AChE) inhibitor for epilepsy Company to host webcast today at 4:30 p.m. ET to discuss the interim data ROCKVILLE, Md., May 23, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced data from the planned interim analysis of the exploratory open-label Phase 2a clinical study of SPN-817 for treatment-resistant seizures. The study is examining the safety and tolerability of SPN-817 as adjunctive therapy in adult patients with treatment-resistant seizures, as well as finding effective doses in various treatment-resistant seizure types. The interim analysis is as of May 1, 2024, and is based on 41 enrolled subjects, of which 19 completed the maintenance period. Of these 19 subjects, 16 subjects had focal seizures. Summary of the Interim Data
“This planned interim analysis of our Phase 2a clinical study provides early, yet what seems to be strong evidence, of the clinical utility of SPN-817 in epilepsy. In addition, the data provide important insights for the design of the upcoming Phase 2b clinical study that we plan on initiating before year end 2024,” said Jack Khattar, President and CEO of Supernus. “We will continue to analyze the valuable inormation provided on safety and tolerability of SPN-817 and the effective dose range in subjects. We will extend the current Phase 2a study to explore potential approaches that we have identified to further improve the tolerability during titration. Full topline results from the Phase 2a study excluding this new extension period are still on track to report in the second half of 2024. We believe SPN-817 could provide a novel, differentiated treatment option for this hard-to-treat and underserved patient population by currently available therapies.” Webcast Details A live webcast with presentation slides will be available via this webcast link or in the Events & Presentations section of the Company’s Investor Relations website at www.supernus.com/investors. Following management’s prepared remarks and discussion of the interim trial results, the call will open for questions. Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time. Following the live call, a replay will be available on the Company's Investor Relations website at www.supernus.com/investors. The webcast will be available on the Company’s website for 60 days following the live call. About SPN-817 (huperzine A) SPN-817 represents a novel mechanism of action (MOA) for an anticonvulsant. SPN-817 is a novel synthetic form of huperzine A, whose MOA includes potent acetylcholinesterase inhibition, with pharmacological activities in CNS conditions such as epilepsy. The development will initially focus on the drug's anticonvulsant activity, which has been shown in preclinical models to be effective for the treatment of partial seizures and Dravet Syndrome. SPN-817 has received Orphan Drug designation for both Dravet Syndrome and Lennox-Gastaut Syndrome from the U.S. Food and Drug Administration (FDA). We are focused on completing and optimizing the synthesis process of the synthetic drug as well as developing a novel dosage form. Given the potency of SPN-817, a novel extended-release oral dosage form is critical to the success of this program because initial studies with the immediate-release formulations of non-synthetic SPN-817 have shown serious dose-limiting, side effects. An open-label Phase 2a clinical study of SPN-817 in adult patients with treatment-resistant seizures is ongoing. About the Phase 2a Clinical Study The study is a Phase 2a multicenter, three-phase, long-term open-label study assessing the safety and tolerability of SPN-817 in adults 18-70 years of age with treatment resistant seizures, as well as assessing efficacy. The screening period is up to 8 weeks in duration. For eligible participants, treatment period is 20 weeks in duration followed by an option open-label extension period which is up to 52 weeks in duration. The primary outcome measure is incidence of AEs and AEs leading to discontinuation. Key secondary outcome measures include: 1) Percent Change from Baseline (PCB) in quantifiable motor seizure frequency per 28 days throughout SPN-817 dosing during maintenance period and open-label extension, 2) Treatment response defined as =30%, =50%, and =75% reduction in quantifiable motor seizure frequency per 28 days relative to the baseline period, 3) Change from baseline in Clinical Global Impression-Severity (CGI-S) scores, and 4) Change from baseline in cognitive profile as assessed by EpiTrack®. About Supernus Pharmaceuticals, Inc. Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, ADHD, hypomobility in Parkinson’s disease (PD), cervical dystonia, chronic sialorrhea, dyskinesia in PD patients receiving levodopa-based therapy, and drug-induced extrapyramidal reactions in adult patients. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders. For more information, please visit www.supernus.com. Forward Looking Statements CONTACTS: Jack A. Khattar, President and CEO or INVESTOR CONTACT: ![]() |