Fortress Biotech’s positive Phase I CEVA101 signals expected to be repeated in Phase II TBI trials; structural preservation endpoints likely correlate with functional outcomes - experts
Fortress Biotech’s (NASDAQ:FBIO) Phase II trials of CEVA101 are likely to see similar meaningful decreases in brain matter volume loss following traumatic brain injury (TBI) as observed in Phase I, experts said. Phase II's imaging-related endpoint is not necessarily a conventional TBI endpoint but is indeed clinically meaningful and is expected to correlate with global functional outcomes, they added.
Analysts have assigned CEVA101 a low probability of success based on historically poor outcomes in TBI studies. However, experts this news service interviewed said they believed the Phase II CEVA101 trials in adult TBI (NCT02525432) and pediatric TBI (NCT01851083) have a reasonable chance of replicating Phase I success.
The Phase I structural preservation of grey and white matter is likely to be repeated in both children and adults in the Phase II, as it is an objective measure independent of confounding factors, experts said. They added that they believe the preservation of this structure is critical to functional neurocognitive outcome measures. CEVA101 is an autologous bone marrow derived mononuclear cell therapy that is being used to decrease neuroinflammation and preserve brain tissue following TBI.