KALA - Kala's Combangio granted $15M by CIRM for development of KPI-012 stock rises 9%

2023-04-28 10:06:26 ET

• Kala Pharma's ( NASDAQ: KALA ) subsidiary Combangio has been granted $15M by the California Institute for Regenerative Medicine (CIRM) to develop KPI-012 for the treatment of persistent corneal epithelial defect.
• ( KALA ) has risen 9.4% .
• The grant includes funding for the Phase 2b clinical trial of CHASE (Corneal Healing After SEcretome therapy), as well as the product and process characterization and analytical development necessary for the program.
• The CHASE Phase 2b clinical trial is being conducted in two patient cohorts. In March 2023, positive safety data was reported from the first patient cohort, which was evaluated for the safety of the high dose of KPI-012 (3 U/mL) topically dosed four times per day ( QID ).
• Currently, the second patient cohort is being enrolled in a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study. The study will evaluate the safety and efficacy of two doses of KPI-012 ophthalmic solution (3 U/mL and 1 U/mL) versus vehicle dosed topically QID for 56 days in approximately 90 patients.
• The primary endpoint of the trial is the complete healing of the PCED, as measured by corneal fluorescein staining. The topline safety and efficacy data is expected to be released in the first quarter of 2024.
• Press Release

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