Kala Halts Development of Investigational PCED Eye Drop After Phase 2b Trial Fails to Meet Endpoints

Kala Bio said it is ceasing development of KPI-012 and its mesenchymal stem cell secretome (MSC-S) platform after its phase 2b trial evaluating KPI-012 in persistent corneal epithelial defect (PCED) did not meet its primary or secondary efficacy endpoints.

The CHASE (Corneal Healing After SEcretome therapy) trial was a multicenter, randomized, double-masked, vehicle-controlled trial designed to test the safety and efficacy of KPI-012 administered topically four times daily over 56 days. Patients enrolled had verified PCEDs at baseline and were eligible for inclusion in the primary efficacy analysis. The trial evaluated two concentrations of KPI-012 ophthalmic solution (3 U/mL and 1 U/mL) against placebo in 79 patients across 37 sites in the US and Latin America. The primary endpoint was defined as complete healing of PCED as measured by corneal fluorescein staining, assessed by a masked central reading center. Neither KPI-012 treatment arm demonstrated a statistically significant benefit compared to placebo. 

The therapy continued to show a favorable safety profile, consistent with earlier studies, but efficacy was not sufficient to warrant further development.

Following these results, Kala said it is evaluating strategic options, including discussions with its secured lender, and will implement cost-saving measures, such as a workforce reduction and other cash-preservation initiatives.

“We are disappointed to see the results of the CHASE study given the positive results KPI-012 yielded in the phase 1b study," said Dr. Kim Brazzell, Head of R&D and Chief Medical Officer of Kala BIO. "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.”