Phase 2b Clinical Study of KPI-012 Topical Ophthalmic Human Mesenchymal Stem Cell Secretome for the Treatment of Persistent Corneal Epithelial Defect
Grant Award Details
Grant Type:
Grant Number:
CLIN2-14516
Investigator(s):
Disease Focus:
Human Stem Cell Use:
Award Value:
$15,000,000
Status:
Active
Grant Application Details
Application Title:
Phase 2b Clinical Study of KPI-012 Topical Ophthalmic Human Mesenchymal Stem Cell Secretome for the Treatment of Persistent Corneal Epithelial Defect
Public Abstract:
Therapeutic Candidate or Device
KPI-012 is a human bone marrow mesenchymal stem cell secretome formulated as a topical ophthalmic therapeutic
Indication
Treatment of persistent corneal epithelial defect, a cornea defect refractory to conventional treatments that can lead to blindness
Therapeutic Mechanism
KPI-012 is intended to restore normal corneal wound healing, providing a curative solution to chronic corneal epithelial lesions and avoiding pathologic sequalae associated with loss of vision. The anticipated benefits are restoration of vision, reduction or elimination of pain, reduced treatment burden, and increased quality of life.
Unmet Medical Need
No effective PCED therapies exist that address all etiologies, as they do not target the multiple dysregulated pathways in persistent wounds. With its ability to target multiple healing pathways, KPI-012 has the potential to heal PCEDs, thereby helping to protect vision and reduce pain.
Project Objective
Phase 2b trial completed and results published
Major Proposed Activities
KPI-012 is a human bone marrow mesenchymal stem cell secretome formulated as a topical ophthalmic therapeutic
Indication
Treatment of persistent corneal epithelial defect, a cornea defect refractory to conventional treatments that can lead to blindness
Therapeutic Mechanism
KPI-012 is intended to restore normal corneal wound healing, providing a curative solution to chronic corneal epithelial lesions and avoiding pathologic sequalae associated with loss of vision. The anticipated benefits are restoration of vision, reduction or elimination of pain, reduced treatment burden, and increased quality of life.
Unmet Medical Need
No effective PCED therapies exist that address all etiologies, as they do not target the multiple dysregulated pathways in persistent wounds. With its ability to target multiple healing pathways, KPI-012 has the potential to heal PCEDs, thereby helping to protect vision and reduce pain.
Project Objective
Phase 2b trial completed and results published
Major Proposed Activities
- • Complete a Phase 2b clinical study to demonstrate safety and efficacy of the therapeutic candidate
- • Conduct product and process characterization studies to support product development
- • Evaluate and develop additional analytical methods for product comparability studies
Statement of Benefit to California:
One of the major contributing factors to development of PCED is diabetes. Over 3 million Californians have diabetes, approximately 43% of whom are at risk for diabetic keratopathy and associated PCED. The availability of an approved curative treatment for PCED will improve quality of life by avoiding loss of vision and its associated loss in productivity for this population.
