Recce Pharmaceuticals releases positive data from Phase II trial of topical gel for skin infections
Recce Pharmaceuticals (ASX: RCE) has released positive patient data analysis from a Phase II clinical trial of its Recce 327 topical gel (R327G) for the treatment of acute bacterial skin and skin structure infections.
The company designed the open-label trial to assess the efficacy and safety of R327G in 30 male and female patients, with one patient withdrawing due to pre-existing pain at a wound site deemed unrelated to R327G.
After seven days of treatment, 25 out of the remaining 29 patients (86%) treated with R327G had a successful clinical response, while 27 patients (93%) had achieved the primary efficacy endpoint by the 14-day mark.
No serious adverse events
The trial met all primary and secondary endpoints relating to the safety and tolerability, efficacy and plasma pharmacokinetics of R327G when applied directly to an infected area.
No serious adverse events were reported.
The results align with the US Food and Drug Administration’s increased demand for novel broad-spectrum antibiotics to address antimicrobial resistance in skin infections.
Unmet medical needs
Recce chief medical advisor Dr Alan Dunton said the trial results underscored the potential of R327G to meet critical unmet medical needs in infection treatment.
“These results reflect the broad-spectrum nature and rapid onset of effect of R327G,” he said.
“We have demonstrated that R327 anti-infective compounds are effective against a diverse species of bacteria, including in vitro against over 500 clinical isolates, many of which were previously considered drug-resistant.”
Diabetic foot infection trial
The Indonesian Drug and Food Regulatory Authority gave Recce approval in December 2024 to initiate a Phase III trial of R327G for the treatment of diabetic foot infections (DFIs).
DFIs, the most common cause of non-traumatic foot amputations in diabetes sufferers, are generally found at the bottom of the foot within the soft tissue and are caused by various pathogens, with up to 80% of wounds being polymicrobial.
Studies have shown that foot ulceration precedes 85% of diabetes-related amputations, with between 14% and 24% of diabetics who develop a foot ulcer ultimately requiring an amputation.
The total medical cost in the US for treating DFIs is as high as $20 billion per year.
Potential treatments
The DFI trial is expected to contribute positively to Indonesia’s healthcare landscape by introducing potential novel treatments for more than 19.5 million adults living with diabetes.
It also aligns with Recce’s commitment to addressing critical health challenges on an international scale.
Recce chief executive officer James Graham said the pivotal trial was a significant achievement that would bring the company closer to commercialisation and profitability.