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A successful phase II clinical trial has taken place, assessing efficacy and safety of R327G in patients with acute bacterial skin and skin structure infections

Recce said objectives exceeded with a 93% primary efficacy endpoint achieved for R327G over 14 days of treatment

Data confirms approach for registrational phase 3 diabetic foot infections Indonesian trial, where efficacy can now be confirmed earlier in trial

Special Report: Recce Pharmaceuticals is up ~9% today after reporting positive patient data analysis from its phase II clinical trial of RECCE 327 topical gel (R327G) for the treatment of acute bacterial skin and skin structure infections, including diabetic foot infections.

Recce Pharmaceuticals (ASX:RCE) said the phase II open-label clinical trial – evaluating the safety and tolerability, efficacy and plasma pharmacokinetics of R327G when applied directly to the infected area – achieved all primary and secondary endpoints.

The trial, including both men and women with a minimum age of 18 years old and no maximum age limit, demonstrated 93% primary efficacy endpoint over 14-days and no serious adverse events.

After seven 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.

The study enrolled 30 patients, with 29 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 One patient was withdrawn due to pre-existing pain at the wound site that was deemed unrelated to R327G.

Recce said the study would progress to a registrational phase 3 in acute bacterial skin and skin structure infections (ABSSSI) and diabetic foot infections (DFIs).

The developer of a new class of synthetic anti-infectives said data received from the phase II trial aligned with the US Food and Drug Administration’s (FDA) increased demand for novel broad-spectrum antibiotics (such as R327G) to address antimicrobial resistance.

ABSSSIs are a significant healthcare concern, encompassing indications such as DFIs, necrotising fasciitis, and post-operative wound infections.

Recce said there were no ABSSSI placebo-controlled studies as international regulators deem it unethical to withhold appropriate treatment of patient infections.

The trial used FDA-accepted diagnosis tools for assessing the severity of patient wounds, including the Lipsky Clinical Resolution of Infection Scale and/or the Bates Jensen Wound Assessment tool.

The study’s investigators used these methods to evaluate patient wound healing and subsequently rated patients as either cured or improved.

Both assessments (cured/improved) demonstrate that wound healing has been observed, with ‘cured’ meaning a full clinical response and ‘improved’ demonstrating partial wound healing with the potential of a cure beyond the 14-day timeframe.

Positive Implications for phase 3 registrational trial

Recce said driven by the high response rates in the phase II study, experts have determined its current registrational phase 3 trial for diabetic foot infections (DFIs) can meet a highly statistically significant positive endpoint earlier after completing 100 patients, compared to the baseline of 300 patients.

The company announced in December it had been granted approval to conduct the registrational trial in Indonesia – which had one of the world’s largest diabetes patient populations – by the Indonesian Drug and Food Regulatory Authority (Badan POM).

The company is forecasting a readout of the interim analysis by the end of 2025.

Recce CEO James Graham said the global ABSSSI treatment market was a substantial commercial opportunity, valued at US$7.3 billion in 2018 and expected to reach US$26bn by 2032, at a CAGR of 9.5% between 2019 and 2032.

“These impressive results underscored the potential of our topical gel to meet critical unmet medical needs in infection treatment,” Graham said.

“As we advance towards registrational phase 3 trials in Indonesia and Australia, we are encouraged by the rapid efficacy and strong safety outcomes demonstrated in this study.”

Recce director and chief medical advisor Dr Alan Dunton emphasised that the company’s robust dataset, from pre-clinical, clinical, and Australia’s Therapeutic Goods Administration (TGA) special access scheme use cases provides confidence in the potential of the topical gel.

“These results reflect the broad-spectrum nature and rapid onset of effect of R327G, which positions us well for the upcoming registrational phase 3 trials in Indonesia and Australia,” Dr Dunton said.

“Importantly, Recce has also demonstrated that its R327 anti-infective compounds are effective against diverse species of bacteria, including in-vitro against over 500 clinical isolates, many previously considered as drug-resistant."

Read the full article here: https://www.theaustralian.com.au/business/stockhead/content/recce-soars-on-phase-ii-skin-infection-trial-results/news-story/f2679c7e698c8f43552bbff08073655f

Recce soars on phase II skin infection trial results