KALA BIO Completes Phase 2b PCED Trial Enrollment, No FDA-Approved Options Exist
核心洞察
KALA BIO (搜索) has completed enrollment of 79 patients in the CHASE Phase 2b trial evaluating KPI-012 for persistent corneal epithelial defect (搜索) (PCED (搜索)), with topline results expected by Q3 2025.
The trial represents a significant milestone for treating an estimated 100,000 Americans with PCED (搜索), as no FDA-approved products currently exist with broad indication for all underlying etiologies.
KPI-012, a human mesenchymal stem cell secretome (搜索) therapy, has received both Orphan Drug and Fast Track designations from the FDA for PCED (搜索) treatment.
KALA BIO (搜索) has completed patient enrollment in its Phase 2b CHASE clinical trial evaluating KPI-012 for the treatment of persistent corneal epithelial defect (搜索) (PCED (搜索)), marking a significant milestone in addressing a rare ocular condition with no approved therapeutic options.
The CHASE (Corneal Healing After SEcretome therapy) trial enrolled 79 patients across 37 sites in the United States and Latin America, all with verified PCEDs at baseline. The multicenter, randomized, double-masked, vehicle-controlled, parallel-group study is evaluating the safety and efficacy of two doses of KPI-012 ophthalmic solution (3 U/mL and 1 U/mL) versus vehicle, administered topically four times daily for 56 days.
Addressing Critical Unmet Medical Need
"The completion of enrollment in the CHASE trial is a significant milestone in our pursuit to develop and deliver a treatment that addresses the high unmet need for patients with PCED (搜索)," said Kim Brazzell, Ph.D., Head of R&D and Chief Medical Officer of KALA BIO (搜索). "There are currently no U.S. Food and Drug Administration (FDA)-approved products with a broad indication covering all underlying etiologies of PCED."
The condition affects an estimated 100,000 people in the United States, representing a substantial patient population with limited treatment options. PCED (搜索) is characterized by impaired corneal healing, which can result from multiple underlying etiologies.
Novel Therapeutic Approach
KPI-012 is a human mesenchymal stem cell secretome (搜索) (MSC-S (搜索)) that contains numerous human-derived biofactors, including growth factors, protease inhibitors, matrix proteins, and neurotrophic factors. These components are designed to potentially correct the impaired corneal healing that underlies multiple severe ocular diseases.
"Given its potential to treat all underlying etiologies of PCED (搜索), we believe KPI-012 could be a significant advance for the treatment of the estimated 100,000 people with PCED in the United States," Brazzell noted.
Trial Design and Regulatory Status
The primary endpoint of the CHASE trial is complete healing of PCED (搜索) as measured by corneal fluorescein staining photographs analyzed by a masked central reading center. This objective measurement approach ensures standardized assessment of treatment efficacy across all study sites.
KPI-012 has received both Orphan Drug and Fast Track designations from the FDA for the treatment of PCED (搜索), reflecting the regulatory agency's recognition of the significant unmet medical need and the therapy's potential clinical benefit.
Timeline and Regulatory Pathway
KALA expects to report topline data from the CHASE trial in the third quarter of 2025. Contingent on positive results and subject to discussion with regulatory authorities, the company believes the CHASE trial could potentially serve as a pivotal trial required to support a Biologics License Application (BLA) submission to the FDA.
The company's broader development strategy includes targeting KPI-012 for other rare corneal diseases, including Limbal Stem Cell Deficiency (搜索), and has initiated preclinical studies to evaluate the potential utility of its MSC-S (搜索) platform for retinal degenerative diseases such as Retinitis Pigmentosa (搜索) and Stargardt Disease (搜索).