Cynata Therapeutics Completes Patient Enrolment for Phase 1 Trial of Diabetic Foot Ulcers

Cynata Therapeutics Ltd (ASX: CYP) continues to advance its cell therapeutics focus with the completion of patient enrolment in its Phase 1 clinical trial of CYP-006TK in diabetic foot ulcers (DFU).

CYP-006TK is a novel silicone dressing seeded with Cynata’s Cymerus mesenchymal stem cells (MSCs).

Due to reduced blood flow, patients with diabetes are at risk of developing non-healing wounds on the feet and lower limbs.

In addition to causing severe pain and discomfort, DFU poses a significant risk of infection, and if therapy is unsuccessful, amputation may be necessary.

In this trial, CYP-006TK is being investigated as a potential treatment to promote wound healing in patients with DFU.

Encouraging results

Cynata recently announced very encouraging initial data from the first 16 patients enrolled in this study after 10 weeks’ follow-up, with a median percentage reduction in wound surface area of 87.6% in the active CYP-006TK group.

This compares to 51.1% in the control group.

Phase 1 sample size

The pre-specified sample size has now been reached, with a total of 30 patients with DFU randomised on a 1:1 basis.

They will receive either CYP-006TK treatment for four weeks, followed by standard-of-care treatment for the rest of the study.

Or the standard of care treatment throughout the study.

Following the study protocol, patients will be followed for 24 weeks following treatment initiation, which means that the last patient visit in this trial is expected to occur around September 2024.

The market opportunity for diabetic foot ulcers is US$9.6 billion.

Cynata is well-funded with $11 million in cash at the end of 2023.

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