An independent non-data safety monitoring board (non-DSMB) has given the green light to Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) to continue the Phase 2 clinical trial of its lead asset RECCE® 327 Gel (R327G), with the trial meeting positive primary endpoints for participants.
On track for end-of-year wrap
The trial is investigating the efficacy of the compound in patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) including diabetic foot infections (DFI) and is on track to be completed within the calendar year.
The board, which is overseeing the trial, reviewed interim safety and efficacy data and confirmed that R327G has an excellent safety profile, being safe and well-tolerated among patients.
No serious adverse events have been recorded – and the trial has thus far yielded highly encouraging efficacy results too.
With these latest findings, Recce Pharmaceuticals is set to advance R327G through the clinical trial process, to establish it as a safe and effective option for treating ABSSSI and related bacterial skin infections.
Efficacy outcomes excellent
The trial is designed to evaluate the efficacy and systemic absorption of R327G when applied directly to the infected area.
The conditions treated included diabetic foot ulcer, eczema, scratch and puncture wound infections.
All patients treated with R327G demonstrated highly encouraging efficacy results including a positive primary endpoint – this means they achieved either a complete cure or improvement.
These results were observed as early as seven days into treatment, which points to the gel’s rapid action against infections.
A wide variety of infecting bacteria (Gram positive and Gram negative) were isolated and successfully treated with Improvement/Cure of infection in all patients that continued with their treatment.
The outcomes were measured using the Lipsky Clinical Resolution of Infection Scale (Lipsky Scale), a tool widely recognised in the assessment of infection resolutions – particularly in diabetic foot infections.
Recognised by the FDA, the Lipsky Scale is an approved and reliable method for evaluating the treatment of wound infections.
The non-DSMB's positive findings further underscore the strong safety profile of Recce’s innovative anti-infective therapy.
While no serious adverse events were noted, one patient was discontinued due to pain at the wound site which was judged to be unlikely related to R327G.
A global market
The Global ABSSSI treatment market size was valued at US$7.3 billion in 2018 and is projected to reach US$26 billion by 2032, representing a CAGR of 9.5% between 2019 and 2032.
Coordinating principal investigator of the study, Professor Eugene Athan, said: "We're seeing some very promising results from the interim data in the Phase 2 trial, which confirm the safety and potential efficacy of R327G in treating Acute Bacterial Skin and Skin Structure Infections, including diabetic foot infections."
Recce CEO James Graham added: “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.”