Kala Pharmaceuticals Submits of Investigational NDA for KPI-012 for the Treatment of Persistent Corneal Epithelial Defect
Kala Pharmaceuticals announced the submission of an investigational new drug application (NDA) to the FDA for KPI-012 for the treatment of persistent corneal epithelial defect (PCED).
Subject to acceptance of the IND by the FDA, Kala remains on-track to initiate a phase 2b clinical trial of KPI-012 for PCED in the fourth quarter of 2022. Topline safety and efficacy data from the trial is expected in the first quarter of 2024. If positive, this trial could serve as the first of two pivotal trials needed to support the submission of a Biologics License Agreement (BLA) to the FDA. Following acceptance of the IND for KPI-012 by the FDA, Kala will receive the second tranche from the private placement of securities announced earlier today which, together with current cash on hand, Kala expects will extend its projected cash runway into the first quarter of 2025.
“We are pleased to announce the submission of the IND for PCED, which brings us an important step closer to our goal of delivering the promise of mesenchymal stem cell secretome (MSC-S)-based therapies to address severe ocular diseases,” Mark Iwicki, Chief Executive Officer and Chairman of Kala Pharmaceuticals, said in a company news release. “This accomplishment is well timed with the investment commitment announced earlier today from a life sciences-focused investor, which reflects a belief in the power of our MSC-S platform to address significant unmet needs across a range of rare ophthalmic diseases and, in particular, the potential for KPI-012 to become the first approved prescription therapy indicated for PCED patients with a broad range of underlying etiologies. We look forward to initiating this trial before year end.”
About KPI-012 for Persistent Corneal Epithelial Defect (PCED)
Persistent corneal epithelial defect, which is defined as a persistent non-healing corneal defect or wound that is refractory to conventional treatments, is a rare disease with an estimated incidence in the United States of 100,000 cases per year. PCED can have various etiologies, including neurotrophic keratitis, surgical epithelial debridement, microbial/viral keratitis, corneal transplant, limbal stem cell deficiency, and mechanical and chemical trauma and, if left untreated, can lead to infection, corneal ulceration or perforation, scarring, opacification and significant vision loss.
Based on its multifactorial mechanism of action and preclinical and clinical data generated to-date, Kala believes KPI-012 may represent a significant advancement in the treatment of PCED and could become the first approved treatment for PCED across all its various etiologies. Kala intends to initiate a phase 2b clinical trial evaluating the efficacy and safety of two doses of KPI-012 in PCED patients with a broad range of underlying etiologies in the fourth quarter of 2022. If positive, this trial could serve as the first of two pivotal trials needed to support the submission of a Biologics License Agreement (BLA) to the FDA.