SPN-820 Shows Promise as Rapid-Acting Antidepressant in Phase 2 Trial
Rapid-Acting Antidepressant Shows Promise in Phase 2 Trial
Phoenix, Arizona – A novel, first-in-class antidepressant called SPN-820 demonstrated rapid symptom advancement and a favorable safety profile in a phase 2 clinical trial presented at the 63rd Annual Meeting of the American College of Neuropsychopharmacology.
The open-label study, lead by Himanshu Upadhyaya, MBBS, MBA, investigated SPN-820 as an adjunctive therapy for adults with major depressive disorder (MDD) who had not found relief with existing FDA-approved treatments.
“Conventional antidepressants can take weeks to work, and they don’t help everyone,” Dr. Upadhyaya explained in an interview with Psychiatric Times. “There’s a critical need for faster-acting antidepressants that can also address suicidal thoughts.”
The trial enrolled 40 adults with MDD and evaluated SPN-820’s safety, tolerability, and preliminary efficacy using a unique every-3-day dosing schedule.
“We found SPN-820 to be very well tolerated,” Dr. Upadhyaya reported. While approximately 60% of participants experienced adverse events, these where primarily mild, with headache, nausea, somnolence, and dizziness being the most common. Importantly, no serious or severe adverse events were reported, and no participants discontinued the study due to side effects.
Rapid Symptom Improvement Observed
Efficacy assessments using the Montgomery-Åsberg Depression Rating Scale (MADRS), the Hamilton Depression Rating Scale (HAM-D 6), and the Clinical Global Impression Scale (CGIS) revealed rapid and significant improvements.
“We saw a very rapid improvement in HAM-D 6 scores within just 2 hours of the first dose,” Dr.Upadhyaya noted. “Subsequent doses further enhanced this improvement.”
MADRS scores also showed positive trends, and a reduction in suicidal ideation was observed.
Unique Mechanism of Action
Unlike other rapidly acting antidepressants that work indirectly through NMDA or 5HT receptors, SPN-820 targets intracellular mTORC1 activity, potentially offering several advantages.“by bypassing those receptors, we believe SPN-820 may have a lower risk of abuse potential and dissociative symptoms, which have been observed with some other rapid-acting antidepressants,” Dr. Upadhyaya explained.
The promising results of this phase 2 trial pave the way for further examination of SPN-820 as a potential new treatment option for MDD, offering hope for faster relief and improved outcomes for patients struggling with this debilitating condition.
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Hope on the horizon: Q&A with Dr. Himanshu Upadhyaya on SPN-820, a Novel Fast-Acting Antidepressant
Dr.Upadhyaya,your phase 2 trial on SPN-820 has generated meaningful interest. Can you describe the unmet need this novel antidepressant aims to address?
Conventional antidepressants can take weeks to work, and they don’t help everyone.Ther’s a critical need for faster-acting antidepressants that can also address suicidal thoughts.
What were the key findings of your study investigating SPN-820 as an adjunctive therapy for major depressive disorder (MDD)?
We found SPN-820 to be vrey well tolerated. While approximately 60% of participants experienced adverse events, these were primarily mild, with headache, nausea, somnolence, and dizziness being the most common. Importantly, no serious or severe adverse events were reported, and no participants discontinued the study due to side effects.
Efficacy assessments using the MADRS,HAM-D 6,and CGIS revealed rapid and significant improvements. We saw a very rapid betterment in HAM-D 6 scores within just 2 hours of the first dose. Subsequent doses further enhanced this improvement.MADRS scores also showed positive trends, and a reduction in suicidal ideation was observed.
SPN-820 has a unique mechanism of action compared to other rapidly acting antidepressants. Can you elaborate on that?
Unlike other rapidly acting antidepressants that work indirectly through NMDA or 5HT receptors, SPN-820 targets intracellular mTORC1 activity. By bypassing those receptors, we believe SPN-820 may have a lower risk of abuse potential and dissociative symptoms, which have been observed with some other rapid-acting antidepressants.
What are the next steps for SPN-820 development?
The promising results of this phase 2 trial pave the way for further examination of SPN-820 as a potential new treatment option for MDD.