After receiving approval from the regulatory authorities, Kala Pharmaceuticals Inc. (Nasdaq: KALA) is soaring on the charts today, up 42.47% to trade at $17.78 at the last check in premarket trading.
What does KALA receive the all-clear for?
The U.S. Food and Drug Administration (FDA) has acknowledged an investigational new drug (IND) application, according to Kala Pharmaceuticals (KALA). For its flagship product prospect, KPI-012, a human mesenchymal stem cell secretome (MSC-S) that was initially developed to treat chronic corneal epithelial deficiency, Kala Pharmaceuticals submitted the IND application (PCED).
The approval of the KPI-012 IND is a significant accomplishment for KALA as the clinical-stage biotech firm strives to realize the potential of its MSC-S platform and improve the lives of those who suffer from uncommon ocular surface illnesses. The first quarter of 2023 will see the start of a Phase 2b clinical study for KPI-012 for PCED as KALA now shifts its attention to clinical execution.
The goal of the Phase 2b clinical trial is to assess the safety and effectiveness of two doses of KPI-012 corneal solution applied externally four times per day (QID) for 56 days to the vehicle in a randomized, multicenter, parallel-group, double-masked investigation. About 90 adult PCED patients are anticipated to join the study, and corneal fluorescein staining will be used to determine the PCED’s full healing as the trial’s primary outcome.
How will KALA develop going forward?
KALA anticipates starting the trial’s enrolment in the first quarter of 2023 and anticipates disclosing top-line findings in the first quarter of 2024. If the trial’s findings are encouraging, KALA thinks it may be the first of two pivotal studies needed to back up the filing of a biologics license application (BLA) to the FDA.
Kala hopes that KPI-012 may represent a substantial improvement in the treatment of PCED and might become the first authorized medication for PCED across all of its many etiologies based on its multifaceted mode of action and clinical and preclinical evidence obtained to date.
KALA took an equity action
In addition, Kala Pharmaceuticals (KALA) this week sold a total of 43,478 shares of Series E Convertible Non-Redeemable Preferred Stock to a life sciences focused-investor for $575.00 per share, generating gross proceeds of $25.0 million. This was done in accordance with the terms of the private placement announced on November 28, 2022, and after the FDA accepted the IND application for KPI-012. KALA raised $31.0 million in total gross funds from the private placement.