Business
Kala Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Corporate Update
-- Announced positive data from initial safety portion of CHASE Phase 2b clinical trial of KPI-012; now enrolling primary safety and efficacy portion of
About this update from Kala Bio, Inc.
[{"type":"text","content":"-- Announced positive data from initial safety portion of CHASE Phase 2b clinical trial of KPI-012; now enrolling primary safety and efficacy portion of trial, with topline data targeted in 1Q 2024 ---- Received FDA Fast Track designation for KPI-012 for the treatment of PCED ---- Strengthened clinical R&D team with appointment of Dr. Francis Mah as Chief Medical Advisor – -- Awarded $15 million grant from CIRM to support the KPI-012 PCED program -- ARLINGTON, Mass., May 09, 2023 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today reported financial results for the first quarter ended March 31, 2023 and provided a corporate update. “The first quarter and recent months were marked by a number of important milestones across our business. We are particularly encouraged by progress in our efforts to advance KPI-012 as the first potential treatment to address all of the underlying etiologies of PCED. We announced positive data from the initial safety portion of the CHASE Phase 2b trial of KPI-012 for PCED, enabling us to advance into the primary safety and efficacy portion of the trial. The KPI-012 PCED program was also granted Fast Track designation by the FDA, which further underscores the importance of the program and the promise of KPI-012 as a novel solution for thousands of PCED patients in need,” said Mark Iwicki, Chief Executive Officer and Chairman of Kala Pharmaceuticals. “In addition, we strengthened our corporate leadership with the appointment of Dr. Francis Mah, an expert in both corneal disease and clinical trial execution, as Chief Medical Advisor, and our wholly-owned subsidiary, Combangio, Inc., was awarded a $15 million grant from the California Institute for Regenerative Medicine (CIRM). We believe the support from CIRM speaks to the potential of KPI-012 – and our MSC-S platform more broadly – as a regenerative approach to improve the treatment of rare ocular diseases. We look forward to advancing the CHASE trial toward initial data readout targeted in the first quarter of 2024, while exploring opportunities to expand our MSC-S platform into additional indications.” First Quarter and Recent Business Highlights: Development-Stage Pip...