Restoration Through Regeneration

We are dedicated to restoring sight to the millions of people who live with corneal diseases through the advancement of regenerative therapies. One Molecule. Two Products. Multiple Potential Indications. Trefoil is advancing two products based on TTHX1114 to treat a spectrum of corneal diseases affecting the back or the front of the cornea. The company’s lead investigational medicine, TTHX1114, is an investigational engineered form of Fibroblast Growth Factor (FGF-1) that has the potential to be first-in-class and is being studied for the treatment of corneal endothelial dystrophies and conditions via intracameral injection. A topical formulation of the product is also under development for the treatment of multiple epithelial indications where corneal ulcerations are present.

NEWS: Our Positive Phase 2 Data Shows Corneal Regeneration and Vision Recovery Following Descemet Stripping Only (DSO) Surgery. Learn more.

An FGF-1 Designed for Pharmaceutical Use

Fibroblast growth factor one (FGF-1) has an extremely short half-life, making it unsuitable for use as a pharmaceutical… until now.

Endothelial Regeneration Program

Intracameral injection of TTHX1114 to restore vision in patients with back of cornea diseases, including the most common, Fuchs Endothelial Corneal Dystrophy (FECD).

Corneal Ulcers Program

TTHX1114 eye drops to reduce the duration and impact of ocular herpes virus related ulcers (herpetic keratopathy) and other corneal ulcers.

Proven Leaders in Cornea Therapeutics

Overview of STORM Phase 2 Trial Study Results with Lead Investigator Dr. Francis Price.

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Trefoil Therapeutics was founded by leaders in FGF-1 research and ophthalmic drug development with a commitment to improve the lives of patients with corneal diseases who have few current therapeutic options. Our team brings more than 100 years of collective experience in ophthalmic pharmaceutical development to our programs.

We are developing first-in class products based on our novel, engineered FGF-1, TTHX1114, to treat corneal endothelial (back of the cornea) diseases, and corneal epithelial (front of the cornea) conditions such as ulcers caused by herpes viruses. The development of these products has been supported by two rounds of venture financing, totaling $33 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.

Based on our progress to date, intracameral injection of TTHX1114, our lead product, has entered clinical trials in 2020 in patients with FECD, with our TTHX1114 topical product expected to begin clinical studies in 2021 for herpetic keratopathy.

Recent News

Trefoil Therapeutics Announces First Patient Dosed in Phase 1 Study of TTHX1114 for Treatment of Corneal Epithelial Defects

Topical formulation of TTHX1114 has potential to accelerate the healing of epithelial defects – a leading cause of blindness worldwide SAN DIEGO–(BUSINESS WIRE)–Trefoil Therapeutics, a clinical-stage biotechnology company focused on restoring sight to people with corneal diseases, today announced the

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Trefoil Therapeutics Announces Positive TTHX1114 Phase 2 Study Data Showing Corneal Regeneration and Vision Recovery following Descemet Stripping Only (DSO) Surgery

Chicago – September 29, 2022 – Trefoil Therapeutics, a clinical-stage biotechnology company focused on restoring sight to people with corneal diseases, today announced positive Phase 2 results for TTHX1114 in patients with Fuchs Endothelial Corneal Dystrophy (FECD). TTHX1114, a proprietary

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Trefoil Therapeutics Announces Third Tranche of $28 Million Series A Financing Based on Achievement of Clinical Trial Objectives

San Diego, CA, December 1, 2021 – Trefoil Therapeutics today announced that after review of the interim clinical data from the INTREPID and STORM studies, the Series A investors have funded the third tranche of its $28 million Series A

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