TTHX1114 for Fuchs' Dystrophy

No longer recruiting at 12 trial locations

Overseen By Thomas M Tremblay, RN, BSN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Trefoil Therapeutics, Inc.

Disqualifiers: Secondary corneal pathology, Prior refractive surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TTHX1114, combined with a procedure known as DWEK/DSO, to assist individuals with Fuchs Endothelial Cell Dystrophy (FECD), a condition where the cornea becomes cloudy. The study includes different groups: some receive TTHX1114 injections with DWEK/DSO, while others undergo the procedure without injections. The trial aims to determine if the combination aids better corneal recovery. Individuals with FECD for over six months who are scheduled for the DWEK/DSO procedure might be suitable candidates for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in FECD treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that TTHX1114, when used with the DWEK/DSO procedure, is generally safe. One study found that participants experienced positive safety outcomes, with only minor side effects. Most side effects were mild and temporary, such as slight discomfort or mild irritation at the injection site.

Additionally, patients in previous studies who received TTHX1114 generally tolerated it well. These findings suggest that TTHX1114 is safe for individuals in the clinical trial process. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for corneal endothelial dysfunction, like corneal transplants, involve invasive surgical procedures and lengthy recovery times. Researchers are excited about TTHX1114 because it offers a potentially less invasive approach by combining with a procedure called DWEK/DSO, which selectively removes diseased cells. Unlike traditional methods, TTHX1114 could stimulate the regeneration of healthy corneal cells, potentially speeding up recovery and improving outcomes. This treatment is unique because it uses a novel mechanism to promote the natural healing process of the cornea, which could reduce the need for transplants in the future.

What evidence suggests that this trial's treatments could be effective?

Research shows that TTHX1114, one of the treatments in this trial, may help treat corneal problems when used with a procedure called DWEK/DSO. Studies have found that this combination can improve vision and increase corneal thickness, both positive signs of healing. In this trial, some participants will receive TTHX1114 with DWEK/DSO, while others will undergo DWEK/DSO without TTHX1114. An earlier study found that patients who received TTHX1114 after surgery experienced better vision recovery. TTHX1114 works by using substances that help repair and regenerate tissue. While more research is needed, these findings suggest that TTHX1114 could improve outcomes for people with corneal conditions. ^{1 3 5 6 7}

Who Is on the Research Team?

Thomas Tremblay

Principal Investigator

Trefoil Therapeutics.com

Are You a Good Fit for This Trial?

Inclusion Criteria

Fuchs Endothelial Cell Dystrophy (FECD) diagnosed more than 6 months

Scheduled for DWEK/DSO with a planned central descemetorhexis of approx 4 to 5 mm

Subjects in Group 2 must have a stable Fellow Eye with adequate function

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TTHX1114 injections and undergo DWEK/DSO

12 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TTHX1114(NM141)

How Is the Trial Designed?

Group I: Group 3a Experimental Treatment 1 Intervention

Study subjects in Group 3a will consist of subjects who had participated in in Group 3 if not recovered from DWEK/ DSO by the median time observed in Group 2 and will receive TTHX1114 (4 injections)

Group II: Group 3 TTHX1114 in combination with DWEK/DSO Experimental Treatment 1 Intervention

Study subjects in Group 3 will receive TTHX1114 (1 injection) and undergo DWEK/ DSO

Group III: Group 2 TTHX1114 in combination with DWEK/DSO Experimental Treatment 1 Intervention

Study subjects in Group 2 will receive TTHX1114 (5 injections) and undergo DWEK/ DSO

Group IV: Group 1a Experimental Treatment 1 Intervention

Study subjects in Group 1a will consist of subjects in Group 1 if not recovered from DWEK/ DSO by Day 84 and will receive TTHX1114 (5 injections)

Group V: Group 1 DWEK/DSO Active Control 1 Intervention

Study subjects in Group 1 will undergo DWEK/ DSO and will not receive any TTHX1114

Who Is Running the Clinical Trial?

Trefoil Therapeutics, Inc.

Lead Sponsor

Trials

4

Recruited

120+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04676737

TTHX1114(NM141) in Combination With DWEK/DSO It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

2. trefoiltherapeutics.com trefoiltherapeutics.com/trefoil-therapeutics-announces-positive-tthx1114-phase-2-study-data-showing-corneal-regeneration-and-vision-recovery-following-descemet-stripping-only-dso-surgery/

Trefoil Therapeutics Announces Positive TTHX1114 Phase ... The Phase 2 STORM trial results showed multiple positive efficacy outcomes for TTHX1114 as an adjunct to DSO and a favorable safety profile, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11034696/

Therapeutic future of Fuchs endothelial corneal dystrophy In this review, we aim to summarize the status of FECD treatment, with a particular emphasis on new clinical trials and related research on nonsurgical ...

4. glaucomatoday.com glaucomatoday.com/articles/2024-jan-feb-insert3/the-potential-of-fibroblast-growth-factors-in-corneal-disease

The Potential of Fibroblast Growth Factors in Corneal ... Effectiveness outcomes with TTHX1114 in the STORM 2 clinical trial. Furthermore, 46% of the enrolled patients underwent cataract surgery concurrently with DSO ...

5. ophthalmologytimes.com ophthalmologytimes.com/view/ascrs-2023-trefoil-therapeutics-tthx1114-improves-rate-of-visual-recovery-after-dso-in-phase-2-storm-data

ASCRS 2023: Trefoil Therapeutics' TTHX1114 improves ... The study results showed TTHX1114 improved best-corrected visual acuity (BCVA) and central corneal thickness (CCT) after DSO in the 49 subjects/ ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/37/NCT04676737/Prot_SAP_000.pdf

Clinical Study Protocol TTHX-002 20220922 A7 • To update Section 2.2.2 with preliminary safety data from Study TTHX-001 (10mcL ... ط DWEK DSO Procedure ↑ TTHX1114 administration ... As the DWEK/DSO procedure ...

7. trial.medpath.com trial.medpath.com/clinical-trial/63ad1bf623a191d1/nct04676737-safety-efficacy-tthx1114-corneal-endothelial-cells

TTHX1114(NM141) in Combination With DWEK/DSO - MedPath Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19. CompletedPhase 1. Bausch ...