The Phase I trial has been designed for evaluating the dosing profile and safety of TTHX1114 as a topical eye drop formulation for reducing the duration and impact of corneal epithelial defects.
TTHX1114 is an engineered, naturally occurring molecule Fibroblast Growth Factor-1 (FGF1) variant.
FGF1 stimulates cell proliferation and migration and protects cells from injury and stress.
The TTHX1114 topical formulation has been designed for expediting the healing of corneal ulcer wounds by stimulating the growth of epithelial cells.
This will potentially reduce common complications, including inflammation, pain, and vision loss, caused due to corneal scarring.
The company has completed a Phase II trial of TTHX1114, designed as an intracameral injection, to treat people with conditions, including Fuchs Endothelial Corneal Dystrophy (FECD), that affect the back surface of the cornea.
Trefoil Therapeutics president and CEO David Eveleth said: “We are excited to take this important step to research TTHX1114 as a topical therapy.
“We now have promising investigational candidates for both front and back of corneal conditions.
“We’re optimistic about what these medicines could mean for people with corneal diseases, and we’re eager to learn more through our research as TTHX1114 advances through the clinical pathway.”
According to the company, approximately 75,000 incidences of corneal ulcers occur in the US every year.
California Pacific Medical Center in San Francisco corneal transplant programme director and corneal and refractive surgery specialist Mark Mandel said: “There is a clear unmet need for a topical therapy for corneal epithelial defects.
“Corneal epithelial defects can develop quickly from eye trauma, bacterial or viral infections such as a herpes reactivation, or from Sjögren’s syndrome, among many other causes. We need a convenient option that can prevent pain and potential vision loss.”