Dr. Vince Clinical Research Announces First Dosing in a Phase II Study in Patients With Depression

Dr. Vince Clinical Research (DVCR), a contract research organization (CRO) specializing in early phase trials, announced the first dosing in a Phase II multicenter trial of SPN-820 in adults with major depressive disorder (MDD). DVCR is acting as the full-service CRO for this trial. MDD is estimated to affect over 17 million adults in the United States, with approximately 30% of these patients being resistant to treatment.

Supernus Pharmaceuticals, in collaboration with Navitor Pharmaceuticals, is developing SPN-820 to provide a rapid-onset antidepressant response via oral administration for adult patients with treatment-resistant depression. The compound has a novel mechanism of action that enhances synaptic activity and cellular metabolism in the brain and has demonstrated a rapid onset of action (signal at two hours) in previous clinical studies. Unlike other rapid-onset compounds currently approved or in clinical development, SPN-820 aims to provide rapid antidepressant efficacy without potential dissociative and neurological side effects.

Jonathan Rubin, M.D., Supernus Pharmaceuticals' Chief Medical Officer, stated, "This study allows us to further evaluate SPN-820's potential rapid onset of effect and the potential to administer this compound once every three days. We are appreciative of the partnership with DVCR for our SPN-820 program."

The Phase II study is being conducted at six U.S. sites and is expected to enroll approximately 50 adult MDD patients. The purpose of the study is to evaluate the efficacy and safety of SPN-820 administered once every three days for a 7-day treatment period. In addition to collecting data from cognitive scales for primary and secondary endpoints, the trial includes multiple pharmacokinetic collections which will be performed during extended study visits.

"Our organization is pleased to contribute toward developing new and potentially more effective treatments for depression," said Brad Vince, DO, DVCR's CEO and Medical Director. "Furthermore, we are excited to continue our strategic growth in this space, enabling us to partner with sponsors beyond their clinical pharmacology studies."

"It has been a collaborative effort with transparent communication between Supernus, study sites and our team which has brought us to this important milestone in this clinical trial," says Korey Nevitt, DVCR's Executive Director of Site Partnerships. "Site identification, feasibility and selection were rapid. This would not have been the case if the sites were not proactive and responsive nor if Supernus' clinical development team was not as passionate about engaging with the sites. I truly believe this is a testament to the unique model DVCR has developed for successfully managing relationships in multicenter trials."

DVCR looks forward to successfully completing this multisite trial and continuing to offer its unique solution to the biopharmaceutical industry.

About Dr. Vince Clinical Research

Dr. Vince Clinical Research (DVCR) is a world-class full-service CRO (Contract Research Organization) with a custom-built, green-designed headquarters and research complex encompassing three buildings in Overland Park, KS. DVCR's complex includes a 90-bed clinical pharmacology unit featuring a combination of luxurious and private research suites and a GMP-compliant pharmacy with positive and negative pressure compounding rooms. DVCR specializes in conducting clinical trials for both healthy normal volunteers and patient populations in a wide variety of early phase trials. By leveraging both technology and one of the country's most experienced leadership teams, DVCR provides Smarter, Faster Data^® to their biopharmaceutical clients.

For more information, go to sponsors.drvince.com. Connect with Dr. Vince Clinical Research on LinkedIn and YouTube.