The company has now dosed all 30 patients in the trial with results pending. Pic: Getty Images
Health & Biotech
Special Report: Recce Pharmaceuticals has wrapped up dosing of all patients in its phase II clinical trial of its topical gel treatment for acute bacterial skin and skin structure infections.
The trial is testing the efficacy of the RECCE 327 topical gel (R327G) applied once daily for seven or 14 days to areas infected by ABSSSI (bacterial infection of the skin and its related tissues).
Recce Pharmaceuticals (ASX:RCE) chief medical advisor Dr Alan Dunton said the “robust results demonstrate the potential of R327G to address the ABSSSI market. And that’s a global market which, the company notes, is predicted to be valued at US$26Bn by 2032, up from US$7.3Bn in 2018.
“We are thrilled to see such robust clinical results from our phase II trial,” Dr Dunton said.
“This milestone marks significant progress in our clinical development journey.”
In recent years, the US Food and Drug Administration (FDA) has increased its focus on the critical role of new broad-spectrum antibiotics (such as R327G) in addressing antimicrobial resistance, particularly when immediate treatment is required, or the pathogen is unknown.
The FDA has also 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.
Not to mention, the World Health Organisation (WHO) added R327 to its list of antibacterial products in clinical development for priority pathogens, recognising Recce’s efforts to combat antimicrobial resistance.
Already, preliminary data is indicating there were no Serious Adverse Events (SAEs) and patients have experienced either a complete cure or significant improvement in infection symptoms following the treatment.
“R327G has made significant progress over the last year, confirming its safety profile and demonstrating impressive efficacy as a topical gel formulation, especially considering the high degree of bacterial resistance present in many of the patients being treated in this Phase II trial,” RCE CEO James Graham said.
“We look forward to the full dataset, which we expect will further support R327G’s progress toward regulatory evaluation.”
A full analysis of results is due in Q1 25, with the company aiming to advance an additional phase III Australian registrational trial in the first half of the year.
The phase III trial will serve as a registrational trial for both the US FDA and Australian Therapeutic Goods Administration.
The company has also received approval for a registrational phase III clinical trial for R327G for the treatment of diabetic foot infections (DFIs) in Indonesia in what will be one of the largest DFIs studies in the world and the first of its kind across Indonesia.
Recce says this trial could lead to potential commercial opportunities for the company in the ASEAN region.
This article was developed in collaboration with Recce Pharmaceuticals, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Health & Biotech
Health & Biotech
Health & Biotech
