ROCKVILLE, Md. - Supernus Pharmaceuticals, Inc. (NASDAQ: NASDAQ:SUPN) has disclosed new findings from a Phase 2a clinical study of SPN-820, a novel treatment for major depressive disorder (MDD), which indicate significant reductions in depressive symptoms and suicidal ideation among participants. The study results were presented at Psych Congress 2024.
In the exploratory open-label trial, 40 adults with MDD were administered 2400 mg of SPN-820 every three days as an adjunct to their current antidepressant therapy. Out of these, 38 subjects completed the 10-day treatment period. The medication led to a clinically meaningful decrease in depression severity according to both the Hamilton Depression Rating Scale-6 items (HAM-D6) and the Montgomery Åsberg Depression Rating Scale (MADRS).
Two hours after administration, patients experienced an average reduction of 6.1 points on the HAM-D6, which further improved to a 9.6 point decrease by Day 10. For the MADRS, reductions of 16.6 points at four hours and 22.9 points at Day 10 were observed. Notably, 50% of participants achieved a rapid MADRS response rate, with a reduction of at least 50% in symptoms at four hours, and 35% reached remission. These improvements increased to 84.2% for response rate and 63.2% for remission by Day 10. Additionally, suicidal ideation among participants decreased by 80%.
SPN-820 was well-received by the study subjects, with few adverse events reported. The most common side effects were mild to moderate and included headache, nausea, somnolence, and dizziness. No severe or serious adverse events were reported.
Jonathan Rubin, M.D., Chief Medical Officer and Senior Vice President of Research & Development at Supernus, expressed optimism about SPN-820's potential, highlighting its rapid antidepressant effects and favorable safety profile. SPN-820 is an orally active small molecule that modulates mTORC1, a component of brain cell function, and is anticipated to offer rapid antidepressant efficacy without dissociative side effects.
Further research, including a Phase 2b clinical study in treatment-resistant depression, is ongoing to confirm these findings. This information is based on a press release statement from Supernus Pharmaceuticals.
In other recent news, Supernus Pharmaceuticals has reported promising results from a Phase 2a clinical trial of SPN-820, a treatment for major depressive disorder. The trial showed that 50% of participants experienced a significant reduction in depression symptoms within four hours of treatment. By Day 10, the response rate improved to 84.2%, with a remission rate of 63.2%. The company also reported a 24% year-over-year increase in total revenue for Q2 2024, reaching $168.3 million, and raised its full-year 2024 financial guidance to a range of $600 million to $625 million.
TD Cowen maintained a Buy rating on Supernus, while Piper Sandler downgraded the stock from Overweight to Neutral, both decisions influenced by recent developments. The U.S. Food and Drug Administration has accepted Supernus's resubmitted new drug application for SPN-830, a device designed for continuous treatment of Parkinson's disease motor fluctuations, with a review date set for February 1, 2025. These are among the recent developments for Supernus Pharmaceuticals.
InvestingPro Insights
The promising results from Supernus Pharmaceuticals' Phase 2a clinical study of SPN-820 for major depressive disorder align with several positive financial indicators for the company. According to InvestingPro data, Supernus boasts impressive gross profit margins of 88.34% for the last twelve months as of Q2 2024, reflecting the company's ability to efficiently manage costs in its drug development and commercialization efforts.
An InvestingPro Tip highlights that Supernus holds more cash than debt on its balance sheet, which provides financial flexibility to continue funding critical research and development projects like SPN-820. This strong financial position is crucial for biotechnology companies as they navigate the costly process of drug development and clinical trials.
Another relevant InvestingPro Tip notes that net income is expected to grow this year. This projection, coupled with the company's recent stock performance—showing a 46.21% price total return over the past year—suggests investor confidence in Supernus's pipeline and commercial prospects.
It's worth noting that Supernus's market capitalization stands at $1.88 billion, indicating a mid-cap company with potential for growth. The stock is currently trading near its 52-week high, with a price that is 96.79% of its peak, possibly reflecting market optimism about developments like the SPN-820 study results.
For investors seeking more comprehensive analysis, InvestingPro offers 11 additional tips for Supernus Pharmaceuticals, providing a deeper understanding of the company's financial health and market position.
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