Trefoil Therapeutics Begins Second Phase 2 “STORM” Clinical Trial with Regenerative Treatment for Fuchs Endothelial Corneal Dystrophy
Trefoil Therapeutics announced it has begun a phase 2 clinical trial of its engineered Fibroblast Growth Factor-1, TTHX1114, to evaluate its safety and efficacy as a regenerative treatment for patients with Fuchs Endothelial Corneal Dystrophy (FECD). The “STORM” study, the second clinical trial of TTHX1114, is designed to assess its potential to enhance corneal recovery and improve visual acuity in FECD patients undergoing Descemetorhexis without Endothelial Keratoplasty (DWEK), which is also referred to as Descemet Stripping Only (DSO), for their disease.
DSO is a surgical procedure which involves the removal of unhealthy endothelial cells and guttae (collagen bodies produced by stressed endothelial cells) in a small central area of the cornea.
“DSO is emerging as a promising alternative to corneal transplantation,” Francis W. Price, Jr., MD, founder and president of Price Vision Group and the Cornea Research Foundation of America (Indianapolis, IN), and an investigator in the trial, said in a company news release. “The procedure relies on the patient’s endothelial cells to migrate and repopulate the region where the cells have been removed to improve the patient’s vision. TTHX1114 is an exciting new option to help endothelial cells regenerate in corneas, and it has the potential to help many people. We are honored to have Price Vision Group participate in this study.”
The multicenter clinical trial is an open label study involving 40 or more patients already scheduled for DSO surgery. The patients will be divided into groups, with one group receiving DSO surgery only, and the other DSO along with TTHX114 intracameral injections. Endpoints being assessed in the study include endothelial recovery, corneal edema & clearing and visual acuity improvement after DSO surgery.
“This clinical trial provides an opportunity to determine whether the striking results we have seen with TTHX1114 in preclinical studies can translate into more rapid recovery of healthy endothelial cells and better vision in the DSO setting,” David Eveleth, PhD, Trefoil Therapeutics’ CEO, said in the news release. “The trial is an important part of our clinical program to develop TTHX1114 as a pharmacological alternative to corneal transplants to improve vision in patients with FECD and other endothelial dystrophies. It also reflects our broader commitment to innovative therapeutics for patients with corneal diseases.”
The company is also developing a topical product based on TTHX1114 for the treatment of corneal epithelial disorders, which is expected to begin clinical trials later this year.