ROCKVILLE, Md. - Supernus Pharmaceuticals, Inc. (NASDAQ: NASDAQ:SUPN), a biopharmaceutical company specializing in central nervous system (CNS) diseases, today announced interim data from its Phase 2a clinical study of SPN-817, a novel acetylcholinesterase inhibitor being tested as an adjunctive therapy for treatment-resistant seizures in adults.
The interim results, based on data as of May 1, 2024, show that SPN-817 led to a median reduction in focal seizures of 75% during the maintenance period at doses between 3mg and 4mg twice daily. During the open-label extension period, the median reduction in focal seizures was 86% at the same dosage levels.
Furthermore, the responder analysis indicated that 81% of subjects with focal seizures experienced a reduction of 30% or more in seizure frequency during the maintenance period, with 63% achieving a reduction of 50% or more, and 19% experiencing a reduction of 75% or more. For subjects with a higher severity of seizures, the median reduction was 74% in the maintenance period and 86% in the open-label extension period.
The study also found that SPN-817 was safe and generally well-tolerated. The most common adverse events related to the drug were consistent with the known profile of acetylcholinesterase inhibitors, including nausea, diarrhea, and headache. The discontinuation rate due to adverse events was 22% during the titration period and 2.4% during the maintenance period.
President and CEO of Supernus, Jack Khattar, stated that the interim data provide strong evidence of SPN-817's clinical utility in epilepsy and will inform the design of the upcoming Phase 2b clinical study, planned to start before the end of 2024. The company aims to report full topline results from the Phase 2a study, excluding the new extension period, in the second half of 2024.
SPN-817 has been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA) for both Dravet Syndrome and Lennox-Gastaut Syndrome. The company is also working on optimizing the synthesis process of the synthetic drug and developing a novel dosage form.
InvestingPro Insights
As Supernus Pharmaceuticals (NASDAQ: SUPN) continues to make strides in its clinical studies, investors are closely monitoring the company's financial health and market performance. The latest data from InvestingPro shows a market capitalization of 1.53 billion USD for the company, reflecting its standing in the biopharmaceutical industry. Despite the challenges of developing treatments for CNS diseases, Supernus boasts an impressive gross profit margin of 87.17% for the last twelve months as of Q1 2024, underscoring its operational efficiency in generating revenue from its sales.
While the company's P/E ratio stands at -97.85, indicating investor caution, the PRONEWS24 promo code can provide savvy investors with an additional 10% off a yearly or biyearly Pro and Pro+ subscription to access deeper insights. This includes a comprehensive list of 7 additional InvestingPro Tips, which highlight key aspects such as the company's cash position relative to debt, the expectation of net income growth this year, and the prediction by analysts that the company will turn profitable within the year.
Investors interested in the long-term potential of Supernus may also note the PEG ratio of 0.74, suggesting that the company's earnings growth might be undervalued relative to its peers. Additionally, the fair value assessments from analysts and InvestingPro set at 41 USD and 32.86 USD respectively, provide a benchmark for evaluating the company's current share price. With the next earnings date scheduled for August 6, 2024, stakeholders will be keen to see how the latest clinical developments might impact the company's financial trajectory.
These financial metrics and InvestingPro Tips could be particularly relevant for investors who are looking to balance the clinical progress of the company with its financial stability and growth prospects.
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