OVERLAND PARK, Kan.—(BUSINESS WIRE)—Dr. Vince Clinical Research (DVCR), a contract research organization specializing in early phase trials, announced the first dosing in a Phase II multi-center 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 towards 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 which DVCR has developed for successfully managing relationships in multi-center trials.”
DVCR looks forward to successfully completing this multi-site trial and continuing to offer its unique solution to the biopharmaceutical industry.
About Dr. Vince Clinical Research
Dr. Vince Clinical Research (DVCR) is a full-service contract research organization (CRO) specializing in early phase trials in both healthy normal volunteers and patient populations across a wide range of trial designs and multiple therapeutic areas such as neuroscience, psychiatry, substance abuse, pain, cardiometabolic disorders, infectious diseases and others. CRO services include project management, data management, biostatistics, monitoring, PK/PD analysis, medical writing as well as site feasibility and management for multi-center trials. Additionally, DVCR operates one of the most innovative and technologically advanced clinical pharmacology units in the world with over 90 beds for overnight confinement, a cGMP compliant pharmacy as well as luxurious amenities to support diverse study participant recruitment and retention. By leveraging technology and one of the country’s most experienced leadership teams in early clinical development, DVCR provides Smarter Faster Data® to their biopharmaceutical clients.
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DVCR Contact
Zach Bader
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(913) 333-3000
Dr. Vince Clinical Research
info@drvince.com