Trefoil Therapeutics was founded by leaders in FGF1 research and ophthalmic drug development with a commitment to improve the lives of patients with corneal diseases who have few current therapeutic options. Trefoil has an experienced management team with over 100 years of collective experience in ophthalmic pharmaceutical development supported by world class ophthalmic physician advisory boards.

Trefoil is developing first-in class products based on our novel, engineered FGF1, TTHX1114, to treat corneal endothelial (back of the cornea) diseases, and corneal epithelial (front of the cornea) conditions. The development of these products has been supported by two rounds of venture financing, totaling $45 million; a significant Collaborative Research and Development Agreement (CRADA) with NIH’s National Center for Advancing Translational Sciences (NCATS); and a U.S. Dept. of Defense grant for proof-of-concept studies of topical TTHX1114 in the treatment of corneal injury.

A proof-of-concept clinical study in Descemet Stripping Only (DSO) has demonstrated faster visual recovery in patients treated with intracameral injection of TTHX1114, including those patients undergoing concomitant cataract surgery. These results support our next step: a Phase 2 study to demonstrate the benefit of TTHX1114 in cataract patients at risk of corneal decompensation.

A Phase 1 safety study has been completed for the topical formulation of TTHX1114 and a Phase 2 trial will begin in late 2023 to assess efficacy in several epithelial conditions.