New Phase 2 Data for TTHX1114 Presented at World Cornea Congress for Corneal Dystrophies presented by Francis Price, Jr. MD
Trefoil Therapeutics announced Phase 2 study data from its STORM clinical trial about a new approach to treating corneal diseases that doesn’t require a transplant. Phase 2 studies help determine if a drug works in a limited group of people, and rules out safety concerns before it moves on to be studied in a larger group of people. Results were presented at the World Cornea Congress in Chicago this week.
The study tested TTHX1114, an engineered fibroblast growth factor-1 (FGF1), as an intracameral (into the eye) injection alongside a Descemet Stripping Only (DSO) procedure.
(Learn more about TTHX1114 here). DSO is an alternative to corneal transplantation that does not require donor tissue. DSO removes the potential for graft rejection and the need for postoperative immunosuppression. But, it can also be an unattractive option for many people because of the long recovery time.
People are born with a set number of endothelial cells. When these cells die or stop working, the cornea can swell and lead to corneal dystrophies. The STORM trial data show endothelial cell restoration and patient-reported visual recovery that indicate endothelial cells are regenerating and helping to accelerate healing after DSO and a single injection of TTHX1114. Importantly, the results show that no serious safety side effects were reported.
The investigational medicine has the potential to be the first drug treatment for corneal endothelial dystrophies.