- Review of blinded data indicates strong efficacy across study population
- RECCE 327 gel continues to demonstrate excellent safety and tolerability
- profile
- Independent data monitoring committee will review unblinded data from phase 3 trial
- Patient recruitment and dosing remain ongoing during this process
Recce Pharmaceuticals (ASX: RCE) has reported a review of blinded data of its current phase 3 trial has indicated a strong efficacy along with a very positive safety profile.
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A data set of 75 patients has now been formally submitted to the data monitoring committee (DMC) who will unblind the data for its phase 3 clinical trial in Indonesia.
The DMC will provide its recommendations to the Company following the conclusion of its meeting expected as soon as mid-November.
The study is a pivotal, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of RECCE 327 Gel (R327G) in the treatment of diabetic foot infections (DFI) in Indonesia. Currently, 90 patients are enrolled with an existing enrolment rate of 4.5 patients per week.
An important component of any pivotal clinical study conducted in accordance with good clinical practice (GCP) is oversight by an independent data monitoring committee. The DMC’s role is to periodically review accumulating clinical trial data, including efficacy and safety outcomes, and provide recommendations regarding the ongoing conduct of the study.
Recce CEO, James Graham, said the independent DMC will unblind and review efficacy and safety data. While the DMC performs this ad-hoc review, the company, clinical investigators and patients will remain fully blinded to the treatment groups to protect the scientific integrity of the trial.
He said this enables the committee to assess patient outcomes by treatment group and determine appropriate recommendations regarding the progression of the study. The study will continue during the DMC review process. This DMC process is built into the clinical trial protocol and typically part of any pivotal GCP protocol.
“The forthcoming DMC review represents an important milestone in our phase 3 diabetic foot infection program,” Mr Graham said.
“While Recce remains blinded to treatment allocation, the overall efficacy and safety profile observed to date is encouraging.
“DFI represents a significant global healthcare challenge and an area of substantial unmet medical need where R327G is anticipated to become the standard of care for the treatment of diabetic foot ulcer infections.”
RCE was up 20.7% to 35.0¢. Mkt cap $88.67M.
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