KALA BIO Announces Topline Results from CHASE Phase 2b Clinical Trial Evaluating KPI-012 for the Treatment of Persistent Corneal Epithelial Defect (PCED) Did Not Meet Primary Endpoint

Core Insights - KALA BIO, Inc. announced that its Phase 2b clinical trial of KPI-012 for treating persistent corneal epithelial defect (PCED) did not meet its primary endpoint of complete healing at Week 8, nor did it achieve statistical significance for secondary endpoints [1][2] - The company plans to cease the development of KPI-012 and its mesenchymal stem cell secretome (MSC-S) platform, while exploring strategic options and preserving cash through workforce reduction and cost-saving measures [2][3] Clinical Trial Details - The CHASE Phase 2b trial was a multicenter, randomized, double-masked, vehicle-controlled study involving 79 patients across 37 sites in the U.S. and Latin America, evaluating two doses of KPI-012 (3 U/mL and 1 U/mL) [4] - The primary endpoint was complete healing of PCED, assessed by corneal fluorescein staining photographs analyzed by a masked central reading center [4] Company Background - KALA BIO is a clinical-stage biopharmaceutical company focused on innovative therapies for rare and severe eye diseases, utilizing its proprietary MSC-S platform [5] - KPI-012, the lead product candidate, is a human MSC-S containing various biofactors and has received Orphan Drug and Fast Track designations from the FDA for treating PCED [5]