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Alan Dunton, MD, director and chief medical advisor, Recce Pharmaceuticals, discusses the company’s novel product, R327G (RECCE 327), and offers insights into its potential indications and clinical trials.

Skin and soft tissue infections, which include acute bacterial skin and skin structure infections (ABSSSI), continue to be challenging. It has been estimated to cause 3.4 million emergency department visits and cost roughly $4.5 billion in the US.

One of the ongoing challenges in treating these troublesome infections is multidrug resistance especially with gram-negative pathogens. Looking to address a limited pipeline, Sydney, Australia-based Recce Pharmaceuticals has developed a novel, topical gel, R327G (RECCE 327), to treat ABSSSI.

“There are currently no fully synthetic antibiotics either on the market or in development to our knowledge. Recce products’ proposed mechanism of action is unique. It cannot be compared in terms of the spectrum of activity which is broad and has not been defeated by any bacteria tested, including multidrug-resistant bacteria and rapidity of onset of activity," Alan Dunton, MD, director and chief medical advisor, Recce Pharmaceuticals, said.

“We started studies with the product as an intravenous formulation, classic phase 1, ascending dose pharmacokinetics, and it was very safe, up to 4000 milligrams IV over 1 hour. It's a broad-spectrum antibiotic. We thought it would be useful as a topical formulation as well. We started with a spray, and we saw some very good results in diabetic foot infections. And then we proceeded to formulate a gel, which we are now using in larger clinical trials as a broad spectrum antibiotic. It has been able to treat every multidrug resistant species provided by the CDC and other clinical specimens.”

Last month, Recce Pharmaceuticals reported positive findings from its phase 2 study examining the efficacy and safety of its product in patients with ABSSSI, including those with diabetic foot infections (DFI). R327G demonstrated a 93% primary efficacy endpoint over 14 days, meeting all study endpoints.

The study enrolled 30 patients and of those, 29 were included in the final data analysis. One patient was withdrawn due to pre-existing pain at the wound site that was deemed unrelated to R327G. The study achieved all primary and secondary endpoints as an open-label clinical trial evaluating the safety, tolerability, efficacy, and plasma pharmacokinetics of R327G when applied directly to the infected area. 

The study included men and women with a minimum age of 18 years old and no maximum age limit. After 7 days of treatment, 86% of patients (25 out of 29) treated with R327G had a successful clinical response. At 14 days of treatment, 93% of patients (27 out of 29) achieved a primary efficacy endpoint. R327G demonstrated to be safe and well tolerated, with no serious adverse events (SAE) reported, achieving all endpoints. 

The company says the data supports potential commercialization for the gel and are moving towards a phase 3 trial in Australia for ABSSSI and DFI. Driven by the high response rates in this study, it has been determined the company’s current registrational phase 3 study for DFI can meet a statistically significant positive endpoint after completing approximately 100 patients compared to the study baseline of 300 patients.

The Indonesian Drug and Food Regulatory Authority (Badan POM) approved protocol has a built-in interim analysis. Recce anticipates completing this data set by the end of the year.

Dunton says they do expect to enter the US market with clinical trials in the future.

“We'll obviously wrap those studies up in Indonesia and Australia, and then move on to the US for the intravenous product,” Dunton said. “We'll probably have a number of products coming out of all that preclinical work that's being done right now, and move into IV studies for complicated urinary tract infection. The drug is highly concentrated in the urine and is able to kill across the spectrum in very high concentrations that occur in the bladder, but these occur very safely. There's no side effects whatsoever when it's exposed in the bladder as well for patients.”

Read the full article here: https://www.contagionlive.com/view/synthetic-gel-shows-utility-across-absssi-company-sees-other-indications

Synthetic Gel Shows Utility Across ABSSSI, Company Sees Other Indications