Antares said it will conduct the trial following US Food and Drug Administration clearance of its investigational new drug application (IND).
The clinical study is expected to investigate several dose strengths of Vibex MTX delivered with Antares’ proprietary auto-injector versus conventional needle and syringe administered by a healthcare professional.
Antares Product Development senior vice president Kaushik Dave said this IND is the result of a dedicated effort by the Antares team to develop a novel product based on the self injection technology that enables patients to administer drugs like methotrexate safely and effectively in a home setting, where there is a clearly defined market need for rheumatoid arthritis patients.
