Promising Advances in Diabetic Foot Ulcer Treatment: Phase 1 Trial Results of Cynata's CYP-006TK

Cynata Therapeutics Limited (ASX: CYP), a clinical-stage biotech company focusing on cell therapeutics, has released initial data from its Phase 1 clinical trial of CYP-006TK for diabetic foot ulcers (DFU).

Key Findings:

·After 10 weeks, the median reduction in wound surface area for patients treated with CYP-006TK was 87.6%, versus 51.1% in the control group.
·25 out of a planned 30 participants have been enrolled in the trial.
CYP-006TK utilizes Cynata's Cymerus™ technology, an iPSC-derived MSC topical wound dressing. DFUs are a severe complication for diabetic patients, leading to non-healing wounds and potentially requiring amputation if untreated. This trial investigates CYP-006TK's efficacy in promoting wound healing in DFU patients. Participants receive either CYP‑006TK for four weeks followed by standard care or only standard care throughout the study.

The trial includes follow-up visits up to 24 weeks post-treatment, during which specialized cameras capture three-dimensional images of the ulcers. Wound surface areas are then calculated by an independent technician.

The data for the first 16 patients (split into two groups of eight) showed a significant median reduction in wound surface area for those treated with CYP-006TK at 87.6%, compared to 51.1% in the control group. These promising results align with earlier findings from the first six patients in the trial.

Given these encouraging outcomes, the trial will continue with a goal of enrolling all 30 participants. Cynata's Chief Medical Officer, Dr. Jolanta Airey, expressed optimism about the trial's progress and its potential to demonstrate the safety and efficacy of CYP-006TK in DFU treatment.

Cynata Therapeutics specializes in the development of regenerative treatments based on their Cymerus™ platform, which allows for economical production of stem cell therapies using iPSCs. Their lead product, CYP-001, has shown positive results for treating steroid-resistant acute graft-versus-host disease in a Phase 1 trial. The Cymerus platform is also being tested in Phase 2 and Phase 3 trials for various conditions, including GvHD and osteoarthritis, with additional trials for renal transplant on the horizon. Preclinical models have shown the platform's potential in a range of diseases, from heart attacks to asthma and sepsis.

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