Acute Bacterial Skin and Skin-Structure Infections

Acute Bacterial Skin and Skin-Structure Infections (ABSSSI)

RECCE® 327 Topical

RECCE® 327 (R327) as a topical formulation is being studied for efficacy on a broad range of bacterial wounds, burns and skin infections.

Overview

Acute bacterial skin and skin-structure infections (ABSSSIs) are a subtype of skin and soft tissue infections, classified as lesions with a minimum surface area of 75 cm and can include cellulitis, major skin abscesses, wound infections, and erysipelas. ABSSSIs present a considerable challenge to the healthcare system. While new antibiotic treatments have recently been developed to combat Gram-positive organisms, there remains a crucial need for antibiotics to address both Gram-positive and Gram-negative pathogens. Those particularly at high risk of skin infections and poor outcomes from ABSSSI are patients with diabetes.

ABSSSI Cases by Geographical Area

Australia

Skin and soft tissue infections occur in

274.2 per 100,000

individuals in Australia
based on a retrospective
study

USA

3.4 million

emergency room visits and a cost of approximately $4.5 billion was caused by skin and soft tissue infections, including ABSSSI.

Phase II Clinical Trial

RECCE® 327 topical gel (R327G) has demonstrated a 93% primary efficacy endpoint in its Phase II clinical trial for Acute Bacterial Skin and Skin Structure Infections (ABSSSI), including Diabetic Foot Infections (DFIs). The trial results confirmed that R327G is safe, well tolerated, and effective, with no serious adverse events reported.

This success supports the Company’s approach for the upcoming registrational Phase 3 trials in Indonesia and Australia. The robust data reinforces the potential of Recce’s synthetic anti-infective technology to address critical unmet needs in infection treatment.

Trial Design

The Phase II clinical trial is an open-label, pilot efficacy study and exploratory evaluation of the systemic bioavailability of single and/or multiple doses of R327 as a topical gel applied to ABSSSI, designed to evaluate the efficacy and systemic absorption of R327G when applied directly to the infected area.

A Significant Opportunity

The global ABSSSI treatment market size was valued at $7.3B USD in 2018 and is projected to reach $26B USD by 2032, representing a CAGR of 9.5% between 2019 and 2032. ABSSSI refers to a bacterial infection of the skin and its related tissues. Examples of skin conditions commonly included in that category are DFIs, necrotizing fasciitis, postoperative wound infections and more.

ABSSSIs present a considerable challenge to the healthcare system. While new antibiotic treatments have recently been developed to combat Gram-positive organisms, there remains a crucial need for antibiotics that can address both Gram-positive and Gram-negative pathogens.

The FDA has increased its focus on the critical role of new antibiotics, specifically broad-spectrum antibiotics (such as R327G) in addressing AMR, particularly when immediate treatment is required, or the pathogen is unknown.

Treatments effective against both Gram-positive and Gram-negative bacteria, enable a rapid response to resistant and mixed bacterial infections. Those particularly at high risk of skin infections and poor outcomes from ABSSSI are diabetic patients.

Patient Journey

While most patients experiencing these infections are successfully treated in an outpatient setting with a course of antibiotics, ABSSSIs are increasingly common in healthcare settings, and frequently, patients are seen having failed their initial course.

The rise of antimicrobial resistance in both Gram-positive and Gram-negative bacteria, particularly methicillin-resistant Staphylococcus aureus (MRSA), presents a growing challenge in treating these infections, as there is an increase in the prevalence of MRSA among hospitalised patients.

Under 50% of patients presenting to their physician have their infection resolved after the first round of antibiotic treatment, requiring adjustments to their care or hospital stays.

About RECCE® 327 Topical

RECCE® 327 (R327) is a synthetic anti-infective developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria, including the full suite of ESKAPE pathogens, even in their superbug forms. R327’s novel mechanism of action (MOA) is designed to safely enter the body, identify and treat an infection, and exit – with the potential to overcome antimicrobial resistance.

R327, as a topical therapy, is being studied in a broad range of bacterial wounds, burns, and skin infections.

In a preclinical study in rats, R327 showed significant antibacterial activity against Methicillin-resistant Staphylococcus aureus (MRSA), difficult-to-treat bacteria that causes staph infections. The data demonstrated a reduced bacterial load and a higher percentage of wound closure with increasing doses of R327 compared to Soframycin.

In an ongoing Phase I/II study in patients with infected burn wounds, R327, as a topical spray, has demonstrated promising data thus far with the return of healthy skin growth, reduced swelling and infection, and indications of tissue penetration to the underlying infection.

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Acute Bacterial Skin and Skin-Structure Infections