Recce Pharmaceuticals Enters Final Phase II Dosing for Acute Bacterial Skin Infections

Recce Pharmaceuticals Ltd, a company specializing in synthetic anti-infectives, has announced significant progress in its Phase II trial of RECCE® 327 topical gel (R327G) for treating acute bacterial skin and skin structure infections (ABSSSI). As of now, 20 out of the 30 total patients have been dosed, and the trial is on track to be completed by the end of 2024. The interim data reveals a promising efficacy and safety profile for R327G, with all treated patients either completely cured or showing notable improvement. No Serious Adverse Events (SAEs) have been reported, indicating a strong therapeutic response.

According to Dr. Alan W. Dunton, Chief Medical Advisor of Recce Pharmaceuticals, these interim results signify a major step forward in addressing critical unmet medical needs in anti-infective therapies. The observed positive outcomes in curing complex bacterial infections, such as diabetic foot infections, highlight the potential impact of R327G as the trial heads toward completion.

The company is committed to delivering a synthetic anti-infective topical therapy to address ABSSSI, a market projected to reach $26 billion by 2032. The continuation of the trial follows the non-Data Safety Monitoring Board’s (DSMB) unanimous endorsement, further supporting the development and regulatory evaluation of R327G.

Recce Pharmaceuticals Ltd is known for developing a new class of synthetic anti-infectives targeting antibiotic-resistant superbugs and emerging viral pathogens. Its anti-infective pipeline includes three patented broad-spectrum synthetic polymer anti-infectives: RECCE® 327 (R327), RECCE® 435 (R435), and RECCE® 529 (R529). These therapies are designed to tackle serious and potentially life-threatening infections caused by Gram-positive and Gram-negative bacteria, including their superbug forms, as well as viral infections. The multi-layered mechanisms of action of Recce’s anti-infectives offer the potential to overcome resistance mechanisms that challenge existing antibiotics.

The World Health Organization (WHO) has recognized Recce’s efforts to combat antimicrobial resistance by including R327, R435, and R529 in its list of antibacterial products in clinical development for priority pathogens. Additionally, the U.S. Food and Drug Administration (FDA) has granted R327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act, which provides Fast Track Designation and 10 years of market exclusivity post-approval. R327 is also listed on The Pew Charitable Trusts’ Global New Antibiotics in Development Pipeline as the sole synthetic polymer and sepsis drug candidate in development.

Recce Pharmaceuticals maintains full ownership of its automated manufacturing processes, which support current clinical trials. By leveraging its unique technologies, the company aims to address synergistic, unmet medical needs through its anti-infective pipeline.

The company's ongoing clinical trials are registered in the Australia New Zealand Clinical Trial Registry, with trial ID ACTRN12624000973516. Recce Pharmaceuticals continues to focus on advancing its pipeline and addressing the urgent global health challenges posed by antibiotic-resistant bacteria and emerging viral threats.