• Recce Pharma says Phase 1/2 study is achieving primary endpoints
  • Cynata also reports also reports good progress in Phase 1
  • Cardiex is back on the ASX!


Recce to expand diabetes foot ulcer Phase 1/2 trial

An independent Safety Committee has unanimously agreed that Recce Pharma’s (ASX:RCE) Phase I/II clinical trial is safe, well tolerated and fit for expanded access.

Recce’s Phase I/II Diabetic Foot Infection (DFI) clinical trial is achieving its primary endpoints, and the independent Safety Committee of Liverpool Hospital NSW has now recommended its expansion to more patients, based on the interim data of the patients that were successfully treated with RECCE 327 (R327).

R327 is a non-invasive method to treat diabetic foot ulcer infections. The drug’s potential as a topical broad-spectrum, anti-infective treatment is the objective of this clinical trial.

Initial results from the trial show that administering R327 daily or once every second day resolved or even cured bacterial infections in diabetic foot ulcers.

Of the estimated 537 million people worldwide who have diabetes, 19% to 34% will develop a diabetic foot ulcer (DFU) in their lifetime.

Approximately 20% of people who develop a DFU will require lower-extremity amputation, either minor (below the ankle), major (above the ankle), or both.

“It gives hope to better patient outcomes and avoiding limb amputation, as is so commonly the case with these complicated patients,” said Professor Hugh Dickson, the principal investigator of the trial.


Cynata’s drug reduces wound surface area in diabetic foot ulcers

Cynata Therapeutics (ASX:CYP) has also updated the market on the progress of its diabetic foot ulcers clinical trial.

Cynata said it has completed its initial analysis of wound surface area in the first 16 patients in its Phase 1 clinical trial of CYP-006TK in DFU, up to the 10-week follow-up time point.

Results show that the median percentage reduction in wound surface area in patients taking CYP-006TK group after 10 weeks was 87.6%, compared to 51.1% in the control group.

For clarity, a 100% reduction in wound surface area means complete wound healing.

These findings are consistent with the results observed from the first six patients enrolled in this trial up to Day 28, which were released in April 2023.

“These initial results are very promising, and consistent with the previous data readout,” said Dr Jolanta Airey, Cynata’s chief medical officer.

“We look forward to completing enrolment in the near future, which will take us a step closer to our objective of demonstrating safety and efficacy of CYP-006TK in DFU.”


CardieX has come out of a 5-month voluntary suspension

Meanwhile, Cardiex (ASX:CDX) has re-listed on the ASX, with its shares available for trading starting today.

CardieX has been on voluntary suspension since September 2023, when the company withdrew its proposed Nasdaq listing due to negative market conditions in the US.

Since that time, CardieX has completed a significant fund raising totalling around $14m, which gives the company a solid capital base going forward.


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