Trefoil Therapeutics chose AGC Biologics, a CDMO, for the manufacture of its lead compound TTHX1114, an engineered form of FGF-1 to restore lost vision in patients with corneal diseases by regenerating corneal tissue.

“AGC Biologics’ extensive experience in cGMP manufacturing makes them an ideal company to help us move TTHX1114 forward,” says  David Eveleth, PhD, CEO, Trefoil Therapeutics, “We believe our engineered FGF-1, which is expected to enter clinical trials during 2020 in an intracameral formulation for the treatment of corneal endothelial dystrophies, has the potential to make a substantial difference in patients’ lives.”

AGC Biologic’s bioprocessing capabilities include a cGMP-compliant facility in Heidelberg, Germany, which will begin manufacturing TTHX1114 in the next few months.

TTHX1114 is an engineered form of FGF-1 designed to stimulate proliferation and migration of corneal endothelial cells. The intracameral injectable formulation of TTHX1114, which is undergoing IND-enabling studies, is designed to regenerate the endothelial cell layer and reduce or eliminate the symptoms associated with endothelial dystrophy, the leading cause of cornea transplantation surgeries.  The topical eye drop formulation of TTHX1114, in preclinical development, is designed for the treatment of ulcerative conditions on the front surface of the cornea.

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