Trefoil Therapeutics Secures $28M Series A Financing to Advance TTHX1114 for Corneal Endothelial Diseases and Plans IND Submission to FDA in Early 2020

On July 16, 2019, VCBeat (WeChat ID: vcbeat) learned that biopharmaceutical company Trefoil Therapeutics announced the completion of a $28 million Series A financing round. The round was led by Bios Partners, with participation from all existing investors, including Access Biotechnology, Hatteras Venture Partners, Aju IB Investment, Correlation Ventures, ExSight Ventures, and InFocus Capital Partners. Dr. Steos M. Robertson will join Trefoil’s Board of Directors; he is a co-founder of Bios Partners and Vice President of R&D at Alcon Laboratories.

Trefoil will use the funds from this financing round to advance its lead candidate, TTHX1114, into human clinical trials and support the completion of a Phase 2a proof-of-concept study for corneal endothelial dystrophy, including Fuchs’ syndrome (heterochromic iridocyclitis), a condition that causes deterioration of the endothelial layer on the posterior surface of the cornea.

Trefoil is expected to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in early 2020 and initiate clinical trials. Trefoil will also use the funds from this financing round to advance the IND application for the topical formulation of TTHX1114 for the treatment of corneal ulcers, and plans to submit a second IND application for corneal epithelial disorders in 2021.

Trefoil Therapeutics is a private biopharmaceutical company headquartered in San Diego, California, USA. The company is dedicated to developing best-in-class therapeutics for severe corneal endothelial and epithelial diseases by leveraging its engineered fibroblast growth factor-1 (eFGF-1) protein technology platform.

Trefoil’s lead candidate product is TTHX1114, an engineered form of FGF-1. TTHX1114 is designed to reverse vision loss by stimulating cell proliferation and migration. The foundational technology of the Trefoil platform was developed by the company’s co-founder, Dr. Michael Blaber, and licensed from Florida State University.

Preclinical data indicate that TTHX1114 accelerates corneal clearance in animal models of corneal endothelial dystrophy and enhances healing in cases of chemical corneal injury and herpetic keratopathy. In human corneal organ culture models, TTHX1114 stimulates the proliferation and migration of endothelial tissue in both normal and diseased corneas, addressing the key deficit in corneal endothelial dystrophy.

“Beyond corneal transplantation, there are limited treatment options for endothelial corneal diseases. Corneal transplantation is invasive, costly, and may require lifelong steroid use for immunosuppression,” said Dr. Richard L. Abbott, Professor Emeritus of Cornea and External Diseases at the University of California, San Francisco. “There is a significant unmet need for pharmacological treatments for Fuchs’ dystrophy and other corneal endothelial diseases, which are among the leading indications for corneal transplantation. TTHX1114 enables earlier intervention for these conditions, potentially minimizing or eliminating the need for surgical procedures.”

“Trefoil is developing TTHX1114, a regenerative therapeutic agent designed to treat corneal dystrophies by reversing vision loss associated with these conditions, while minimizing the need for extensive surgical intervention,” said Dr. David Eveleth, Founder and CEO of Trefoil. “We appreciate the support of all our investors. We are confident in our ability to make a meaningful impact on the lives of patients with corneal diseases, and we look forward to initiating Phase I clinical trials early next year.”

Bios Partners is a venture capital firm focused on investing in early-stage biopharmaceutical and medical device companies. Founded in 2014 and headquartered in Fort Worth, Texas, USA, Bios Partners is dedicated to investing in innovative early-stage and growth-stage biotechnology and medical device companies.

Hatteras Venture Partners, established in 2000 and headquartered in Durham, North Carolina, USA, is a venture capital firm. Hatteras Venture Partners focuses on investing in biopharmaceuticals, medical devices, diagnostic manufacturing, human medicine, and related fields. The company manages three funds with assets under management exceeding $120 million.

Aju IB Investment, established on September 1, 1974, is headquartered in Seoul, South Korea. Aju IB Investment is a venture capital firm specializing in providing investment and consulting services to small and medium-sized enterprises (SMEs). The company manages approximately $1 billion in capital.

Correlation Ventures, established on May 1, 2006, is headquartered in San Diego, California, USA. As an emerging venture capital firm, Correlation Ventures leverages world-class analytics to provide better options for entrepreneurs and other venture capitalists. Backed by its investors, Correlation manages assets exceeding $350 million.

ExSight Ventures, founded in 2014 and headquartered in New York, USA, is a company focused on investing in the medical diagnostics sector, specializing in early-stage investments in innovative ophthalmic diagnostic and therapeutic solutions. The firm is composed of two experienced retinal surgeons and a team of investment professionals who provide funding to early-stage ophthalmology companies.

InFocus Capital Partners specializes in providing early-stage funding for ophthalmic research companies. The leadership and advisory team at InFocus comprises clinical ophthalmologists, ophthalmology business experts, clinical research specialists, and experienced financial executives.

(Compiled by Cheng Tao)