Today, Boehringer Ingelheim announced that they are partnering with VeraSci on an innovative phase III program in cognitive impairment associated with schizophrenia (CIAS) for the investigational treatment BI 425809. The FDA has granted Breakthrough Therapy Designation (BTD) for BI 425809 for the treatment of CIAS.
The program will be using VeraSci’s Pathway eCOA platform, including VeraSci’s Virtual Reality Functional Capacity Assessment Tool (VRFCAT), which simulates key instrumental activities of daily living in a realistic and interactive virtual environment. The VRFCAT, which is sensitive to functional capacity deficits, has been accepted into the FDA’s Clinical Outcome Assessment Qualification Program. The trials will also utilize speech biomarker technology from Aural Analytics, which will provide a richer picture of trial participants’ language function alongside more traditional clinical outcome measures.
“VeraSci is excited to take part in this landmark innovative trial in CIAS,” says VeraSci CEO Dr. Rich Keefe. “Innovative solutions are imperative to making meaningful progress in this difficult illness. We are hopeful that this research will be an important step forward for the field.”