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Recce Pharmaceuticals Moves Forward with Phase II ABSSSI Trial After Safety Approval

Recce’s R327G Phase II trial shows promising safety and efficacy for ABSSSI; non-DSMB endorses.

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  • Oct 28, 2024

  • Simantini Singh Deo

Recce Pharmaceuticals Moves Forward with Phase II ABSSSI Trial After Safety Approval

Recce Pharmaceuticals Limited is excited to share that an independent non-Data Safety Monitoring Board (non-DSMB) has successfully concluded its evaluation of the safety and efficacy data from the Company’s ongoing Phase II clinical trial. This trial focuses on the Company’s lead compound, RECCE® 327 Gel (R327G), targeting patients suffering from Acute Bacterial Skin and Skin Structure Infections (ABSSSI), which encompasses diabetic foot infections (DFI).


In their assessment, the non-DSMB reported no safety issues and unanimously endorsed the continuation of the clinical trial, which is expected to wrap up by the end of the year. This recommendation stems from the impressive safety profile of R327G, which recorded no serious adverse events (SAEs) among patients, along with highly promising efficacy data.


Most patients treated with R327G exhibited remarkable efficacy, with all those who completed the treatment meeting the primary endpoint and achieving either a complete cure or significant improvement. Notably, many patients experienced complete resolution of their condition within just seven days.


These results were evaluated using the Lipsky Clinical Resolution of Infection Scale (Lipsky Scale), a well-established instrument for assessing infection resolution, particularly in diabetic foot infections. The FDA recognizes the Lipsky Scale as an approved and dependable method for evaluating wound infection treatments. The non-DSMB's favorable findings reinforce the robust safety profile of Recce’s pioneering anti-infective therapy.


The conditions addressed comprised diabetic foot ulcers, eczema, and infections from scratches and puncture wounds. A diverse range of bacteria, both Gram-positive and Gram-negative, were identified and effectively managed. All patients who adhered to their treatment protocols experienced improvement or complete resolution of their infections.


Professor Eugene Athan, Coordinating Principal Investigator of the study, said in a statement, "We're seeing some very promising results from the interim data in the Phase II trial, which confirm the safety and potential efficacy of R327G in treating Acute Bacterial Skin and Skin Structure Infections, including diabetic foot infections."


CEO, James Graham, mentioned, “We are extremely encouraged by the feedback from the non-Data Safety Monitoring Board and the ongoing safety and efficacious profile of R327G. The absence of serious adverse events, coupled with the wide range of broad-spectrum efficacy across challenging wound infections, reinforces the potential of R327G to address unmet medical needs in the treatment of serious bacterial infections.”

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