SPN-820 is being developed as a rapid-acting treatment for major depressive disorder. Credit: shisu_ka via Shutterstock.

Supernus Pharmaceuticals has said its candidate SPN-820, demonstrated a “rapid and substantial” effect in a Phase IIa trial for adults with major depressive disorder (MDD).

The Phase IIa study (NCT06235905) met its primary endpoint – showing a clinically meaningful improvement of -6.1 on the Hamilton Depression Rating Scale-6 items (HAM-D6) at two hours, improving to -9.6 by day 10. Suicidal ideation decreased by 80%, from 12.5% at baseline to 2.6% on day ten.

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Commonly used antidepressants, such as selective serotonin reuptake inhibitors (SSRIs), often take several weeks to start showing noticeable effects. In contrast, SPN-820 is under development as a rapid-acting treatment, designed to provide faster symptom improvement. This offers quicker relief for patients with MDD, particularly those at risk of suicidal ideation.

Out of the 40 adults enrolled in the open-label study, 38 completed the 10-day treatment period. Supernus said that SPN-820 was well-tolerated in the study with adverse events (AEs) including headache, nausea, and sleepiness.

SPN-820 is a first-in-class, oral small molecule drug designed to enhance synaptic function in the brain by activating the mechanistic target of the rapamycin complex 1 (mTORC1) pathway. This mechanism boosts synaptic activity and cellular metabolism, leading to improved brain function. The company expects SPN-820 to offer rapid antidepressant benefits without the dissociative side effects associated with other antidepressants.

SSRIs, such as Pfizer’s Zoloft (sertraline) and GSK’s Paxil (paroxetine), are associated with side effects like dizziness, weight gain, and sexual dysfunction. These side effects can affect patients’ adherence to the drugs, leading to relapse or worsening of depression symptoms.

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Supernus’ CEO Jack Khattar said: “These Phase IIa data underscore our belief that SPN-820 has the potential as a novel treatment option for patients with depression, with the opportunity to decrease symptoms quickly and without certain burdensome side effects.” 

A Phase IIb study (NCT05066672) of SPN-820 in approximately 227 adult patients with treatment-resistant depression is ongoing. The company expects to complete enrolment in November of this year, with topline results expected in H1 2025, added Khattar.

Beyond the MDD space, September 2024 saw Bristol Myers Squibb’s (BMS) first-in-class schizophrenia drug Cobenfy (xanomeline-trospium) win US Food and Drug Administration (FDA) approval. The novel drug introduces a new mechanism of action by targeting cholinergic receptors as opposed to dopamine receptors.

Enrolment of patients with mental health diagnoses in clinical trials has been an ongoing challenge for the industry due to lack of diagnosis, finding the right participants and ensuring they have the necessary support.