On-track to initiate Phase 2b trial in 4Q 2022, with topline data expected in 1Q 2024 --
-- Cash runway extended into 1Q 2025, pending receipt of second tranche from previously announced financing, due upon FDA acceptance of KPI-012 IND --
Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare diseases of the eye, today announced the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (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.
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