Trefoil Therapeutics announced the release of new data from its phase 2 study assessing the safety and efficacy of TTHX1114, its lead investigational candidate, following Descemet Stripping Only (DSO).
Refresh me on TTHX1114.
TTHX1114 is Trefoil’s first investigational engineered variant of the naturally occurring molecule of Fibroblast Growth Factor-1 (FGF-1).
The topical formulation is designed to accelerate 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).
TTHX1114 is delivered via an intracameral injection.
Now talk about this trial.
The open-label, non-randomized phase 2 STORM trial (NCT04676737) assessed the use of TTHX1114 as an adjunct to DSO in 49 participants (64 eyes; 51% male; mean age of 69.4 years) with (46% of subjects) and without combination cataract surgery.
Patients were administered three active doses:
- Group 2 = Low-dose repeat administration
- Group 3 = High-dose single administration
- Group 4 = High-dose repeat administration
What was measured?
Efficacy measurements were best-corrected visual acuity (BCVA) and central corneal thickness (CCT); a BCVA responder was defined as achieving 20/40 or better following DSO, while a CCT responder was an eye with a post-DSO CCT measurement less than pre-DSO.
Findings?
A faster time to a BCVA of 20/40 was noted in patients with a smaller DSO (4 mm = 4.5, 4.5 mm = 6.7, ≥5 mm = 6.3) and slower in patients with diabetes (7.7 vs 5.2, respectively).
However, there were no significant differences observed in recovery for patients receiving combination cataract surgery versus DSO alone.
Any adverse events?
Not really… mainly mild and moderate, with none determined to be related to TTHX1114.
Bottom line?
Based on the data, TTHX1114 improved visual recovery and corneal deturgescence following DSO in a dose-responsive manner.
Further, visual outcomes for patients receiving DSO did not appear to be affected by simultaneous cataract surgery.
Thoughts.
According to Trefoil CEO and President David Eveleth, PhD, the findings support the hypothesis that FGF-1, “leverages in the inherent regenerative properties of corneal endothelial and epithelial cells with TTHX1114 to restore vision.”