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KALA BIO, Inc. develops a dual strategy that combines a clinical-stage biologics pipeline for rare and severe eye diseases with an on-premises artificial intelligence infrastructure platform for biotechnology and pharmaceutical clients. Company updates cover the MSC-S platform, the KPI-012 clinical program, Researgency.ai, and the Bionic Intelligence Research Agent for secure research, clinical, regulatory, and data-workflow applications.
News also addresses capital-structure actions and corporate-status developments, including registered equity offerings, debt settlement, Nasdaq listing matters, governance changes, and the completed 1-for-50 reverse stock split of KALA common stock.
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Kala Pharmaceuticals (NASDAQ:KALA) announced that the FDA has granted Fast Track designation for its KPI-012 therapy, aimed at treating persistent corneal epithelial defect (PCED), a rare and serious eye condition affecting approximately 100,000 patients in the U.S. This designation aims to expedite the development and review process, facilitating more frequent interactions with the FDA. KPI-012, based on a human mesenchymal stem cell secretome (MSC-S) platform, seeks to address the unmet medical needs of PCED patients, for whom no approved treatments currently exist. Kala is advancing its Phase 2b clinical trial, with promising initial safety results reported, and aims to present topline data in Q1 2024, potentially using this trial as one of the two pivotal studies required for a Biologics License Application (BLA).
Kala Pharmaceuticals (NASDAQ: KALA) has appointed Dr. Francis Mah as Chief Medical Advisor. Dr. Mah, an expert in corneal disease, will support the company’s clinical development, particularly for KPI-012, its treatment for Persistent Corneal Epithelial Defect (PCED). Recently, Kala reported positive safety data from its CHASE Phase 2b trial of KPI-012. Dr. Mah's extensive experience and research background will aid in advancing KPI-012 and exploring its application for other rare ocular diseases. PCED affects approximately 100,000 people annually in the U.S., underscoring the need for effective therapies.
Kala Pharmaceuticals announced positive safety data from the first cohort of its CHASE Phase 2b trial for KPI-012, aimed at treating persistent corneal epithelial defect (PCED). The initial cohort involved two patients treated with a high-dose regimen, both of whom completed the treatment without safety issues. The trial is now progressing to Cohort 2, which will assess the safety and efficacy of two doses of KPI-012 in about 90 patients. Topline data is expected in Q1 2024, and positive results could pave the way for pivotal trials supporting a Biologics License Application to the FDA.
Kala Pharmaceuticals, Inc. (NASDAQ: KALA), a clinical-stage biopharmaceutical firm focused on innovative therapies for severe eye diseases, will present at the Oppenheimer 33rd Annual Healthcare Conference on March 15, 2023. A virtual fireside chat with management is scheduled for 12:00 p.m. ET, along with one-on-one meetings available on the same day. Kala is advancing its lead product candidate, KPI-012, designed to address persistent corneal epithelial defect and has received orphan drug designation from the FDA. The company aims to explore additional indications, including Partial Limbal Stem Cell Deficiency and retinal degenerative diseases.