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Kala Pharmaceuticals Announces Positive Safety Update from Cohort 1 of CHASE Phase 2b Clinical Trial Evaluating KPI-012 in Patients with PCED
--No safety issues identified in Cohort 1 ---- Now proceeding to Cohort 2 to evaluate the safety and efficacy of two doses of KPI-012 in a multicenter,
About this update from Kala Bio, Inc.
[{"type":"text","content":"--No safety issues identified in Cohort 1 ---- Now proceeding to Cohort 2 to evaluate the safety and efficacy of two doses of KPI-012 in a multicenter, randomized, double-masked, vehicle-controlled trial ---- Topline data for Cohort 2 targeted for 1Q 2024; if positive, trial could potentially serve as first of two pivotal trials required to support submission of a BLA -- ARLINGTON, Mass., March 27, 2023 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today announced positive safety data from the first cohort of the CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial evaluating KPI-012, a human mesenchymal stem cell secretome (MCS-S), for the treatment of persistent corneal epithelial defect (PCED). The first cohort enrolled two patients, treated with a high dose of KPI-012 (3 U/mL) four times per day (QID). Both patients successfully completed at least one week of dosing with no safety issues observed. The trial will now advance to Cohort 2. The CHASE trial includes two patient cohorts. The first cohort is an open-label study to evaluate the safety of the high dose of KPI-012 (3 U/mL) dosed topically QID in two patients. The second cohort is a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study to evaluate the safety and tolerability 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. Kala is targeting reporting topline safety and efficacy data in the first quarter of 2024. If the results are positive, and subject to discussion with regulatory authorities, Kala believes this trial could serve as the first of two pivotal trials required to support the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration. “We are encouraged by the early safety data from the CHASE Phase 2b trial. Generating positive safety data at the high dose and moving to Cohort 2 represents a significant milestone for our KPI-012 development program. Based on these results, we are moving quickl...