Published in Pipeline

First patient dosed in phase 1 study for CED treatment

This is editorially independent content
2 min read

Trefoil Therapeutics announced that it has dosed the first patient in a phase 1 safety study assessing TTHX1114, its lead investigational candidate, for the reduction in duration and impact of corneal epithelial defects (CED).

I need a quick background on Trefoil Therapeutics.

The clinical-stage biotech company is centered on using novel engineered fibroblast growth factor-1 (e-FGF-1) compounds—which protects cells from stress and injury and stimulates cell proliferation and migration—to restore sight to patients diagnosed with corneal diseases and disorders. (via)

Tell me about TTHX114.

TTHX114 is Trefoil’s first investigational FGF-1 with a topical formula designed to advance corneal ulcer wound healing by stimulating epithelial cell growth and potentially reducing complications often associated with corneal ulcers (pain, inflammation, loss of vision due to corneal scarring). (via)

How does it work?

An intracameral injection of TTHX114 is administered into the eye, directly behind the cornea, using a small needle.

What else should I know?

Trefoil recently completed a phase 2 trial (NCT04676737) where TTHX114 was studied as an intracameral injection—into the anterior chamber of the eye—for patients with Fuchs’ endothelial dystrophy and other conditions affecting the back surface of the cornea. The company reported positive data in September 2022. (via)

Tell me about this new study.

The phase 1 study (NCT04812067) is assessing TTHX114’s safety and dosing as a topical eye drop formulation for the treatment of CED.

Significance?

Per Trefoil’s President and CEO David Eveleth, PhD, the launch of this latest trial studying TTHX114 as a topical therapy gives the company the potential for investigational candidates for both the front and back of corneal conditions.

When can we expect results?

No word yet … stay tuned!