Trefoil Therapeutics Announces First Patient Dosed in Phase 1 Study of TTHX1114 for Treatment of Corneal Epithelial Defects
Trefoil Therapeutics announced dosing of the first patient in its phase 1 safety study evaluating TTHX1114 as a topical eye drop formulation designed to reduce the duration and impact of corneal epithelial defects.
The phase 1 study is designed to assess the safety and dosing profile of TTHX1114 in a topical eye drop formulation. The company has also completed a phase 2 study of TTHX1114 as an intracameral injection for people with conditions that affect the back surface of the cornea, such as Fuchs Endothelial Corneal Dystrophy (FECD). Positive data from the STORM study were presented at the World Cornea Congress 2022.
“There is a clear unmet need for a topical therapy for corneal epithelial defects,” Mark Mandel, MD, a corneal and refractive surgery specialist and director of the corneal transplant program at California Pacific Medical Center in San Francisco, said in a company news release. “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.”
TTHX1114 is an investigational engineered variant of the naturally occurring molecule Fibroblast Growth Factor-1 (FGF1), which stimulates cell proliferation and migration as well as protecting cells from stress and injury. The topical formulation of TTHX1114 is designed to accelerate corneal ulcer wound healing by stimulating epithelial cell growth, potentially reducing common complications associated with corneal ulcers, such as pain, inflammation, and loss of vision due to corneal scarring, according to Trefoil. The company also has a clinical program for TTHX1114 as an intracameral injection into the eye for patients with Fuchs Endothelial Corneal Dystrophy (FECD) and other corneal endothelial dystrophies (CED), aimed at protecting and regenerating corneal endothelial cells lost due to the disease and thereby improving vision.
“We are excited to take this important step to research TTHX1114 as a topical therapy,” said David Eveleth, PhD, President and CEO of Trefoil Therapeutics. “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.”