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

SAN DIEGO--(BUSINESS WIRE)--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 financing to support the development of its engineered FGF-1, TTHX1114 products for the regenerative treatment of corneal diseases. This funding allows Trefoil to expand the STORM clinical program and initiate a clinical trial of the topical formulation.

Christy Shaffer, PhD, General Partner of Hatteras Venture Partners and Trefoil board member commented: “Trefoil has exceeded our expectations. They are defining a new category for the treatment of corneal endothelial dysfunction. With the clinical data the company has generated, Trefoil has the potential to transform how diseases like Fuchs dystrophy are treated. My co-investors and I are proud to have backed this highly focused management team that is advancing innovative science to the benefit of patients who currently have limited treatment options.”

“The funding for this tranche reflects the significant clinical advances we have made with our intracameral product for Fuchs and other corneal endothelial dystrophies, as well as progress in our preclinical program for topical TTHX1114 for the treatment of corneal ulcers,” said David Eveleth, PhD, Trefoil’s, CEO. “Over the last 15 months, we completed the first-in-human, Phase 1/2, INTREPID, safety trial of TTHX1114. We are now nearing completion of the Phase 2 STORM trial to evaluate our product’s potential to enhance corneal recovery and improve visual acuity in Fuchs patients undergoing Descemet Stripping Only (DSO) procedures.”

TTHX1114 is a patented, engineered form of FGF-1 designed to leverage the protein’s natural activity to stimulate cell proliferation and migration as well as protect cells from injury and stress. Trefoil’s clinical program for TTHX1114 in Fuchs and other corneal endothelial dystrophies (CED) is aimed at regenerating corneal endothelial cells lost due to the disease and thereby improving vision. Fuchs Dystrophy is the leading cause of corneal transplantation in the U.S. Corneal transplant is currently the only treatment option for many people with CED. Although transplant surgery with human donor corneas may be effective in restoring vision, post-surgical recovery can be challenging, and most patients require long‑term immune suppression therapy to minimize the risk of graft rejection. TTHX1114 has also shown in animal models a reduction in the severity of both chemical and herpes-induced corneal damage. Trefoil’s clinical program for the topical formulation of TTHX114 will assess the decrease in corneal opacity associated with these conditions and corneal ulcers in general.

About Trefoil Therapeutics

Trefoil Therapeutics is a clinical stage biotechnology company focused on leveraging its engineered FGF-1 protein technology platform to develop first-in-class pharmacologic treatments for serious corneal endothelial diseases and epithelial disorders. Trefoil’s lead product candidate is TTHX1114, an engineered form of naturally occurring FGF-1 designed to stimulate corneal endothelial cell proliferation and migration, thereby reversing vision loss caused by CED. The technology underlying Trefoil’s platform was developed by co-founder Michael Blaber, Ph.D., and is licensed from Florida State University. Learn more at www.trefoiltherapeutics.com.

Safe Harbor Statement

The research discussed in this press release is preliminary and the outcome of such studies may not be predictive of the outcome of later clinical trials. Future clinical trial results may not demonstrate safety and efficacy sufficient to obtain regulatory approval related to the nonclinical research findings discussed in this press release.

Robert Gottlieb
RMG Associates, LLC
857-891-9091 (mobile)
Robertmg52@gmail.com