Kala Pharmaceuticals, Inc. 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 quickly to initiate the second patient cohort,” said Kim Brazzell, PhD, head of R&D and CMO of Kala Pharmaceuticals. “We believe the multifactorial mechanism of action of KPI-012 can address impaired corneal healing at multiple points in the healing process, potentially enabling us to provide the first therapy to address all underlying etiologies of PCED. We believe KPI-012 could fill a large unmet need in this rare disease and look forward to the continued development of KPI-012 for the estimated 100,000 people annually suffering from PCED in the United States and the thousands of other PCED patients around the world.”