KALA BIO Completes Patient Enrollment in the CHASE Trial
ARLINGTON, Mass. - KALA BIO, Inc. (NASDAQ: KALA), a pioneering biopharmaceutical entity dedicated to innovative eye treatments, is thrilled to announce that it has successfully completed patient enrollment for its pivotal CHASE trial. This phase 2b clinical trial is focused on evaluating KPI-012, a novel human mesenchymal stem cell secretome treatment intended for persistent corneal epithelial defect (PCED).
Significance of the CHASE Trial
The CHASE trial stands as a multicenter, randomized, double-masked study evaluating the efficacy and safety of two distinct doses of KPI-012—3 U/mL and 1 U/mL—administered topically four times a day over a period of 56 days. This innovative research involves 79 patients from 37 clinical sites across the United States and Latin America who have been diagnosed with verified PCEDs.
Key Objectives and Endpoints
The primary objective of the trial is to achieve complete healing of PCED, as indicated through corneal fluorescein staining analyzed by an independent, masked central reading facility. The anticipated outcomes are to provide critical insights into the therapeutic abilities of KPI-012 and its potential as a groundbreaking treatment for individuals suffering from this debilitating condition.
Expert Insights and Expectations
Kim Brazzell, Ph.D., KALA BIO's Head of R&D and Chief Medical Officer, commented on this major milestone: "Completion of enrollment marks an essential step towards addressing the critical unmet needs of those living with PCED. Currently, there are no FDA-approved treatments that comprehensively target all underlying causes of PCED, making KPI-012 a promising candidate for those affected. We estimate around 100,000 individuals in the U.S. are affected by this condition, highlighting the urgent need for effective treatment solutions."
Future Outlook for KPI-012
KALA anticipates releasing topline results from the CHASE trial by the end of Q3 2025. Provided the data is favorable, there is potential for the trial to serve as a pivotal study necessary for submitting a Biologics License Application (BLA) to the FDA. Notably, KPI-012 has already received both Orphan Drug and Fast Track designations from the FDA, highlighting its significance.
About KALA BIO’s Innovations
KALA is dedicated to innovating therapies for rare and severe ocular diseases. Its proprietary MSC-S platform enables the development of biologics-based therapeutics, with KPI-012 being the lead product candidate. This treatment harnesses a rich array of human-derived biofactors, aimed at rectifying impaired corneal healing, a core concern in severe ocular conditions. KALA is also exploring the potential of KPI-012 in treating Limbal Stem Cell Deficiency and other rare corneal diseases while initiating preclinical studies for retinal degenerative diseases such as Retinitis Pigmentosa and Stargardt Disease.
Frequently Asked Questions
What is the CHASE trial focused on?
The CHASE trial is dedicated to evaluating the safety and efficacy of KPI-012 for treating persistent corneal epithelial defect (PCED).
How many patients were enrolled in the trial?
A total of 79 patients have been enrolled from 37 sites in the United States and Latin America.
What is the expected timeline for topline results?
KALA BIO expects to report topline results by the end of Q3 2025.
What designations has KPI-012 received?
KPI-012 has received both Orphan Drug and Fast Track designations from the FDA.
How is KALA BIO contributing to eye health?
KALA BIO is advancing innovative therapies specifically for rare and severe eye diseases, aiming to provide effective treatments where few exist.
