Cynata Therapeutics Limited (ASX:CYP) Reports Positive DFU Trial Results

Clinical Trial Results

Cynata Therapeutics Limited (ASX:CYP) has successfully completed its Phase 1 clinical trial of CYP-006TK for diabetic foot ulcers (DFU). The trial demonstrated that CYP-006TK is both safe and well-tolerated, with no participants withdrawing due to adverse events. Significant efficacy data showcased improved wound healing when compared to the standard of care control group.

Key Performance Indicators

After 12 weeks, the CYP-006TK group exhibited a mean decrease in wound surface area of 181 mm², while the control group showed an increase of 355 mm². At the end of the 24-week period, the CYP-006TK group achieved a decrease of 261 mm² compared to an increase of 62 mm² in the control group. Notably, the treatment group demonstrated a mean percentage reduction in wound area of 64.6% at 12 weeks and 83.6% at 24 weeks, contrasting with 22.0% and 47.8% in the control group.

CEO Comments

Dr Kilian Kelly, CEO and Managing Director of Cynata, expressed his satisfaction with the trial outcomes, stating, “We are very pleased and encouraged by these results. First and foremost, the trial achieved its primary objective of safety. Furthermore, while the trial was not powered to show statistically significant efficacy, we believe there is a clear signal indicating improved wound healing compared to standard treatments.”

Future Developments

The company plans to engage with regulatory agencies and potential commercial partners to further the development of CYP-006TK. Cynata awaits results from three more clinical trials expected within the next 18 months, enhancing the commercial potential of its Cymerus™ platform technology.

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