Recce Pharmaceuticals Ltd is nearing the finish line of its Phase II clinical trial evaluating RECCE® 327 topical gel (R327G) for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The trial has reached a significant milestone, with 20 out of the planned 30 patients now dosed. Interim data from the study highlights the potential efficacy and safety of R327G.
Promising Efficacy and Safety Profile
According to the company's announcement, all patients who have completed treatment with R327G have demonstrated a positive therapeutic response, achieving either a complete cure or a notable improvement in their condition. Importantly, no serious adverse events (SAEs) related to R327G have been reported during the trial.
"These interim results reflect a remarkable advancement in our journey to address critical unmet medical needs in anti-infective therapies," stated Alan W Dunton, MD, Chief Medical Advisor of Recce Pharmaceuticals. "The robust response we are seeing with R327G is encouraging, especially as we near the completion of the Phase II trial. Achieving a response of complete cure or notable improvement in all patients treated so far highlights the potential impact of R327G in treating complex bacterial infections, including diabetic foot infections."
Trial Design and Progress
The Phase II trial is designed to assess the safety and efficacy of R327G in patients with ABSSSI. The primary endpoints of the study focus on evaluating the rate of clinical cure and the incidence of adverse events. The trial is registered on the Australia New Zealand Clinical Trial Registry (ACTRN12624000973516).
Recce Pharmaceuticals anticipates completing patient dosing by the end of 2024. The company is focused on developing a synthetic anti-infective topical therapy to address ABSSSI, a market projected to reach $26 billion by 2032.
RECCE® 327: A Novel Anti-Infective
RECCE® 327 is a broad-spectrum, synthetic polymer anti-infective being developed for both intravenous and topical applications. It is designed to combat serious and potentially life-threatening infections caused by Gram-positive and Gram-negative bacteria, including superbug forms. The World Health Organization (WHO) has recognized R327 as an antibacterial product in clinical development for priority pathogens. The FDA has granted R327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act, providing Fast Track Designation and 10 years of market exclusivity post approval.
