Kala Bio, Inc. announced in a press release that its CHASE (Corneal Healing After SEcretome therapy) phase 2b 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 company also said that 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.

Based on the CHASE trial results, Kala said it plans to cease development of KPI-012 and its mesenchymal stem cell secretome (MSC-S) platform. Kala also said that it plans to evaluate its strategic options and as part of its evaluation to engage in discussions with its secured lender. In the interim, the company plans to take steps to preserve cash, including by conducting a reduction in workforce and other cost-saving measures.

“We are disappointed to see the results of the CHASE study given the positive results KPI-012 yielded in the phase 1b study," said Kim Brazzell, PhD, head of R&D and chief medical officer of Kala Bio, in the press release. "KPI-012 continued to be well-tolerated and demonstrated a favorable safety profile but did not demonstrate the efficacy results that would warrant advancing the program for treatment of front-of-the-eye diseases. We would like to thank all of the patients and investigators who participated in the CHASE trial.”