Kala Bio tanks on Phase IIb KPI-012 miss
US eye disease specialist Kala Bio (Nasdaq: KALA) saw its shares close down almost 90% at $2.04 yesterday, after it revealed disappointing trial results for its KPI-012.
Kala Bio announced that its CHASE (Corneal Healing After SEcretome therapy) Phase IIb clinical trial of KPI-012 for the treatment of persistent corneal epithelial defect (PCED) did not meet the primary endpoint of complete healing of PCED as measured by corneal fluorescein staining. The CHASE trial also failed to achieve statistical significance for key secondary efficacy endpoints and did not show any meaningful difference between either KPI-012 treatment arm and the placebo arm, the company noted.
Due to the failed results, Kalo Bio said it plans to cease development on KPI-012. The investigational drug had previously received both orphan drug and fast track designations from the US Food and Drug Administration (FDA). In addition to ceasing production on KPI-012, the company also plans to end its mesenchymal stem cell secretome (MSC-S) platform.
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