Trefoil Therapeutics announced it raised $28 million in an oversubscribed Series A financing. The company is developing novel engineered fibroblast growth factor-1 proteins (eFGF-1) as a regenerative pharmacologic therapy to treat serious corneal endothelial diseases and epithelial disorders.
Trefoil’s lead candidate TTHX1114 is an engineered form of the FGF-1 protein designed to reverse vision loss by stimulating endothelial cell proliferation and migration. Preclinical data has demonstrated TTHX1114’s ability to accelerate corneal clearing in animal models of corneal endothelial dystrophy and enhance healing in corneal chemical injury and herpetic keratopathy, according to Trefoil. In human cornea organ culture models, TTHX1114 stimulates the proliferation and migration of endothelial tissue in both normal and diseased corneas, addressing the key defect in corneal endothelial dystrophies.
This funding supports the completion of a phase 2a proof-of-concept study in corneal endothelial dystrophy, including Fuchs dystrophy, a disease which leads to the deterioration of the endothelial layer on the back surface of the cornea. Trefoil anticipates filing an investigational new drug (IND) application with the FDA in early 2020 and initiating the clinical trial soon thereafter.
“Therapeutic options for endothelial corneal diseases are limited aside from cornea transplant surgery, which is invasive, expensive and may require life-long steroid use for immunosuppression,” Richard L. Abbott, MD, Professor Emeritus, Cornea and External Diseases, UCSF Department of Ophthalmology, and Research Associate, Francis I. Proctor Foundation, said in a company news release. “Fuchs dystrophy and other corneal endothelial diseases are among the leading causes of corneal transplantation. There is a high unmet need for a pharmacologic option that would allow treatment of these diseases earlier and potentially reduce or eliminate the need for surgical intervention.”
The funding also enables Trefoil to move forward with IND-enabling studies of a topical formulation of TTHX1114 for the treatment of ulcerative conditions of the cornea, with a planned submission of a second IND for corneal epithelial conditions in 2021.
“Trefoil is developing TTHX1114 with the goal of providing the first regenerative therapeutic agent for the treatment of corneal dystrophy to reverse the vision loss associated with these conditions without the need for surgery for many patients,” David Eveleth, PhD, Co-Founder and Chief Executive Officer of Trefoil, said in the news release. “We are grateful to our new and existing investors, who recognize the opportunity we have to make a meaningful difference in the lives of people with sight-destroying corneal diseases and conditions. We look forward to initiating our first clinical study early next year.”
“Trefoil’s regenerative approach offers a promising opportunity to develop first-in-class pharmacologic treatments for corneal diseases,” said Dr. Robertson. “With its strong scientific foundation, compelling preclinical data and leadership team’s depth of experience in ophthalmic drug development, Trefoil is well-positioned to bring these therapies to market. We are pleased to support Trefoil at this pivotal time.”
The financing included new investors Bios Partners, which led the round, and Access Biotechnology. All existing investors, including Hatteras Venture Partners, Aju IB Investment, Correlation Ventures, ExSight Ventures and InFocus Capital Partners, participated in this financing. Stella M. Robertson, PhD, co-founder of Bios Partners, and a former vice president in Research & Development at Alcon Laboratories, will join Trefoil’s Board of Directors.