Recce Pharmaceuticals Ltd. has announced that it has dosed 15 patients in its Phase II trial evaluating RECCE® 327 topical gel (R327G) for the treatment of acute bacterial skin and skin structure infections (ABSSSI). This milestone marks the halfway point in the trial, which is expected to enroll a total of 30 participants by the end of 2024.
The Phase II trial is designed as an open-label, pilot efficacy study to evaluate the efficacy and systemic absorption of R327G when applied directly to the infected area. The study is also exploring the systemic bioavailability of single and/or multiple doses of R327 as a topical gel for ABSSSIs.
Addressing Unmet Needs in ABSSSI Treatment
ABSSSIs, which include diabetic foot infections (DFI) and other wound infections, represent a significant healthcare challenge with substantial unmet medical needs. The increasing frequency of bacterial skin infections, particularly those caused by drug-resistant strains, is expanding the ABSSSI market. According to company estimates, the global ABSSSI market was valued at $1.34 billion in 2023 and is projected to reach $2.31 billion in the next 10 years.
"We are thrilled to pass the halfway point of this pivotal Phase II study for the unmet clinical need of topical skin infections," said James Graham, Chief Executive Officer of Recce Pharmaceuticals. "Indications of promising antibacterial effect are significant achievements, with patient recruitment to be completed within the year."
Promising Antibacterial Effects and Tolerability
Initial data indicate that R327G has been safe and well-tolerated across subjects, demonstrating promising antibacterial responses in patients. These findings suggest a significant opportunity to expand the application of R327G's formulation.
Expanding Trial Locations
In addition to the lead site, Barwon Health, Recce Pharmaceuticals has added two new sites: the Australian Clinical Research Network NSW and ACRN Melbourne. This expansion aims to broaden access to this potentially novel treatment approach for patients with ABSSSI.
Recce's Anti-Infective Pipeline
Recce Pharmaceuticals is focused on developing a new class of synthetic anti-infectives to address the global health challenges posed by antibiotic-resistant superbugs and emerging viral pathogens. The company's anti-infective pipeline includes RECCE® 327 (R327) as an intravenous and topical therapy, RECCE® 435 (R435) as an orally administered therapy for bacterial infections, and RECCE® 529 (R529) for viral infections.
Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the processes utilized by bacteria and viruses to develop resistance, a significant challenge facing existing antibiotics. R327 has been granted Qualified Infectious Disease Product designation by the FDA, providing Fast Track Designation and 10 years of market exclusivity post approval.
