Cynata Therapeutics has announced positive results from its Phase 1 clinical trial of CYP-006TK, a topical wound dressing for diabetic foot ulcers (DFU). The trial, conducted across multiple centers in Australia, met its primary objective of safety and tolerability while also demonstrating encouraging efficacy signals in wound healing compared to standard of care.
The results offer a potential new avenue for treating DFUs, a significant complication of diabetes that affects millions worldwide and often leads to amputation. The company is now focusing on further clinical development and engagement with regulatory agencies to bring this innovative product to market.
Phase 1 Trial Design and Outcomes
The Phase 1 trial randomized 30 patients with DFUs to receive either CYP-006TK treatment for four weeks followed by standard of care, or standard of care alone for the duration of the 24-week study. The primary endpoint was safety and tolerability, with secondary endpoints assessing wound healing.
No participants withdrew from the trial due to adverse events, and no suspected serious adverse reactions were reported. Mild to moderate local administration site reactions were the only adverse events possibly related to CYP-006TK, occurring in seven participants.
Efficacy in Wound Healing
Wound surface area was measured using three-dimensional imaging at each follow-up visit. The mean change from baseline in wound surface area was:
- After 12 weeks: a decrease of 181 mm2 in the CYP-006TK group, compared to an increase of 355 mm2 in the control group.
- After 24 weeks: a decrease of 261 mm2 in the CYP-006TK group, compared to an increase of 62 mm2 in the control group.
Expressed as a percentage, the mean change from baseline in wound surface area was:
- After 12 weeks: a decrease of 64.6% in the CYP-006TK group, compared to a decrease of 22.0% in the control group.
- After 24 weeks: a decrease of 83.6% in the CYP-006TK group, compared to a decrease of 47.8% in the control group.
While these differences were not statistically significant, which was expected due to the study not being powered to show efficacy, Cynata's CEO Dr. Kilian Kelly stated that the company believes "there is a clear signal indicating improved wound healing compared to standard of care treatments in this trial."
Enhanced Healing in Larger Wounds
An analysis segmenting participants by wound size at baseline showed that CYP-006TK had a more pronounced benefit in larger wounds (greater than 200 mm2). In this subgroup:
- After 12 weeks: the CYP-006TK group showed a decrease of 262 mm2, while the control group showed an increase of 540 mm2.
- After 24 weeks: the CYP-006TK group showed a decrease of 354 mm2, while the control group showed an increase of 135 mm2.
Expressed as a percentage, the mean change from baseline in wound surface area for larger wounds was:
- After 12 weeks, a decrease (improvement) of 68.4% in the CYP-006TK group compared to an increase of 3.9% in the standard of care control group.
- After 24 weeks, a decrease (improvement) of 84.2% in the CYP-006TK group compared to a decrease of 32.2% in the standard of care control group.
"This indicates that the potential wound healing benefit of CYP-006TK is even greater in larger wounds. This is especially encouraging as patients with larger wounds are more likely to experience an amputation," the company said in a press release.
The Need for New DFU Therapies
Diabetic foot ulcers are a significant health and economic burden. Approximately 38 million Americans have diabetes, and up to 34% of them will develop DFUs. These ulcers can lead to severe pain, infection, and amputation, with approximately 20% of DFU patients requiring amputation. The annual cost to treat DFUs in the U.S. ranges from $9-13 billion.
"Diabetic foot ulcers represent a substantial unmet medical need," said Dr. Jolanta Airey, Cynata’s Chief Medical Officer. "There is a desperate need for more effective interventions to improve wound healing and thus reduce the risk of severe infection and amputation."
Next Steps for CYP-006TK
Cynata is now focusing on the next steps for CYP-006TK, including further clinical development, engagement with regulatory agencies like the FDA, and seeking potential commercial partners. The company believes that these results further validate the commercial potential of its Cymerus™ platform, which has also shown promise in graft-versus-host disease.
