Kala Bio Halts Eye Drug Development After Phase 2b Trial Failure
New Delhi: KALA BIO, Inc. a clinical-stage biopharmaceutical company focused on eye diseases, announced that its CHASE Phase 2b trial for KPI-012 in the treatment of persistent corneal epithelial defect (PCED) did not meet its primary endpoint of complete healing by Week 8. Secondary efficacy endpoints also failed to reach statistical significance.
Despite the disappointing efficacy results, the trial confirmed that KPI-012 was well tolerated, with no treatment-related serious adverse events observed.
Based on these outcomes, KALA BIO plans to cease further development of KPI-012 and its mesenchymal stem cell secretome (MSC-S) platform. The company will now explore strategic alternatives, including discussions with its secured lender, and take steps to preserve cash — such as workforce reductions and cost controls.
“We are disappointed to see the results of the CHASE study … 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,” said Kim Brazzell, Ph.D., Head of R&D and Chief Medical Officer at KALA.
The CHASE trial was a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study comparing two doses of KPI-012 ophthalmic solution (3 U/mL and 1 U/mL) against vehicle (placebo) administered topically four times daily (QID) for 56 days. The trial enrolled 79 patients across 37 sites in the United States and Latin America, all of whom had verified PCED at baseline.
The primary endpoint was defined as complete healing of PCED, assessed by corneal fluorescein staining images interpreted by a masked central reading center.
The failure of KPI-012 to demonstrate efficacy in this phase 2b trial marks a major setback for KALA BIO’s MSC-S platform. With the program discontinued, the company will need to pivot or reallocate resources to other pipeline assets, or evaluate mergers, partnerships, or licensing opportunities. The announced cost-saving measures and cash-preserving steps reflect the company’s need to maintain solvency during this transition.
KALA also cautioned that its statements about strategic plans, cost reductions, and future expectations are forward-looking and subject to risks and uncertainties.
